This material is intended for global medical media only.
This material is not approved for Canadian journalists or Canadian audiences.
For journalistic assessment and preparation before publication.
Results from the Perceptions of Control (POC) study showed that people with type 2 diabetes uncontrolled on basal insulin were reluctant to intensify insulin therapy due to concerns such as medication side effects, perceptions of getting sicker and not wanting to add more injections. Physicians' concerns around insulin intensification included a lack of patient agreement to intensify insulin therapy, hypoglycaemia and patients' cognitive status.[1] Findings from the Perceptions of Control study which evaluated the perceptions of diabetes control amongst patients and physicians were presented today at the World Diabetes Congress of the International Diabetes Federation (IDF).
"A better understanding of how patients and physicians make decisions around insulin intensification could significantly improve communication during consultations and help people with type 2 diabetes, uncontrolled on basal insulin, to intensify treatment when needed," said Meryl Brod, PhD, lead investigator of the POC study. "Addressing patient concerns with additional information and treatment options may lead to an increased number of patients agreeing to change their treatment to get into better control."
The POC study results showed that people with type 2 diabetes uncontrolled on basal insulin were apprehensive to intensify therapy and initiate basal-bolus insulin despite their physician's recommendation due to factors such as fear of weight gain caused by the medication (45%), feeling they were getting sicker (44%), fear of hypoglycaemia (low blood sugar) (41%) and not wanting to add more injections (41%).[1] In total, over half (57%) were only somewhat or not at all willing (39% somewhat / a little willing, 18% not at all willing) to add one additional daily injection of bolus insulin to help control their type 2 diabetes and 37% were concerned that the regimen would be too complicated.[1]
Physician study participants reported that the primary reason they were reluctant to intensify insulin therapy for people with type 2 diabetes uncontrolled on basal insulin was due to thinking their patients would not agree (62%).[1] Physicians were also reluctant to intensify therapy due to concerns around hypoglycaemia (46%), especially if it was particularly dangerous in a patient's workplace (54%).[1] Physicians were also concerned about recommending intensification if a patient had a mental illness or altered mental status (48%),[1] poor cognitive skills (46%) and concerns of patient compliance (41%).[1]
About the Perceptions of Control (POC) Study The POC study was based on information collected from a web survey of 300 physicians and 1,012 adults with type 2 diabetes uncontrolled on basal insulin (physician-confirmed HbA1c> 8% (64 mmol/mol)) from the UK (n=100 physicians and 620 patients), Sweden (n=100 physicians and 240 patients) and Switzerland (n=100 physicians and 152 patients). Information was also collected from a control group of 295 adults with type 2 diabetes controlled on basal insulin (physician-confirmed HbA1c <7.5% (59 mmol/mol) from the UK. In total, data were collected from 1,607 patients and physicians for analysis.[1]-[3] The purpose of the study was to explore how physicians and people with type 2 diabetes define control, identify obstacles to achieving control,[2],[3] perceive the impact of uncontrolled type 2 diabetes on daily life[2],[3] and reluctance to intensify insulin therapy.[1]
About Novo Nordisk Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ]
Further information
Media:
Katrine Sperling
+45 4442 6718
krsp@novonordisk.com
Asa Josefsson
+45 3079 7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45 3075 9085
phak@novonordisk.com
Daniel Bohsen
+45 3079 6376
dabo@novonordisk.com
Melanie Raouzeos
+45 3075 3479
mrz@novonordisk.com
Kasper Veje
+45 3079 8519
kpvj@novonordisk.com
Frank Daniel Mersebach (US)
+1 609 235 8567
fdni@novonordisk.com
References
1) Brod M, Pfeiffer KM, Barnett AH, et al. Patient/physicians inertia in insulin intensification for patients with uncontrolled type 2 diabetes using basal insulin. Poster presentation (1081-P) at the International Diabetes Federation (IDF) World Diabetes Congress, 1 December 2015.
2) Brod M, Pfeiffer KM, Barnett AH, et al. Perceptions of control among type 2 diabetes patients treated with basal insulin. Poster presentation (0742-P) at the International Diabetes Federation (IDF) World Diabetes Congress, 1 December 2015.
3) Brod M, Pfeiffer KM, Barnett AH, et al. Perceptions of diabetes control among physicians and patients with uncontrolled type 2 diabetes using basal insulin. Poster presentation (0741-P) at the International Diabetes Federation (IDF) World Diabetes Congress, 1 December 2015.
Source: Novo Nordisk
PRNewswire
Showing posts with label Novo Nordisk. Show all posts
Showing posts with label Novo Nordisk. Show all posts
Friday, December 4, 2015
Ryzodeg(R) Delivers Significantly Lower Rates of Hypoglycaemia and Nocturnal Hypoglycaemia in a Broad Range of Type 2 Diabetes Patients
- This material is intended for global medical media only.
- This material is not approved for Canadian journalists or Canadian audiences.
- For journalistic assessment and preparation before publication.
Abstracts 0336-P, 0337-P, 0338-P
New analyses demonstrate that Ryzodeg(R) (insulin degludec/insulin aspart) achieved successful glycaemic control with significantly lower rates of hypoglycaemia (low blood sugar) and nocturnal hypoglycaemia in patients with type 2 diabetes versus BIAsp 30 and/or a basal-bolus regimen of insulin degludec and insulin aspart[1]-[3]. These findings were presented today at the 23rd World Diabetes Congress of the International Diabetes Federation (IDF).
The analyses of pooled data from five clinical studies highlighted that these benefits were delivered to patients irrespective of baseline HbA1c, disease duration or body mass index (BMI)[1]-[3]. The results also revealed that Ryzodeg(R) versus both comparators resulted in statistically significant reductions in fasting plasma glucose (FPG), and a lower insulin dose with significant differences in patients with BMI less than or equal to30 or a disease duration longer than 10 years[1]-[3].
"Managing hypoglycaemia while also achieving optimal glycaemic control are important considerations when selecting a treatment regimen," commented Dr. Helena Rodbard, presenting author of the analyses. "These findings are especially relevant in the era of personalised medicine, and provide valuable assistance to the clinical use of Ryzodeg(R) in patients with type 2 diabetes."
These data are from the analyses of five 26-week treat-to-target phase 3a/b clinical trials in people with type 2 diabetes.
About the analyses
The post-hoc pooled analyses evaluated the efficacy and safety of Ryzodeg(R) in controlling glycaemic parameters and rates of hypoglycaemia in patients with type 2 diabetes stratified according to baseline HbA1c, disease duration and body mass index (BMI). End of trial HbA1c, FPG, insulin dose and confirmed and nocturnal confirmed hypoglycaemia were analysed in the aforementioned patient categories, according to baseline characteristics stratification: HbA1c (<7.5%, greater than or equal to7.5-<8.5%, greater than or equal to8.5-<9.0%, greater than or equal to9.0%), FPG (<5.5, >5.5-<7.0, >7.0-<10.0, >10.0 mmol/L), disease duration (less than or equal to10 or >10 years) and BMI (less than or equal to30 or >30 kg/m2)[1]-[3].
About Ryzodeg(R)
Ryzodeg(R) is a combination of two distinct insulin analogues (insulin degludec and insulin aspart in the ratio of 70% and 30%) making it the first combination of a basal insulin with a long duration of action and a well-established mealtime insulin in one pen for people with type 2 diabetes[4]-[6]. Ryzodeg(R) delivers a simple regimen with fewer injections than basal and bolus therapy[7].
Ryzodeg(R) received its first regulatory approval in December 2012, and has since been approved in more than 60 countries globally. Ryzodeg(R) was most recently approved by the U.S. Food and Drug Administration on 25 September 2015 for the treatment of diabetes mellitus in adults and is currently commercially available in India, Mexico and Bangladesh.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ] References
1) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma glucose and
hypoglycaemia rates independent of baseline HbA1c. Presented at the IDF World Diabetes
Congress, Vancouver, Canada; 30 November - 4 December 2015.
2) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma glucose and
hypoglycaemia rates independent of disease duration. Presented at the IDF World
Diabetes Congress, Vancouver, Canada; 30 November - 4 December 2015.
3) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma glucose and
rates of hypoglycaemia irrespective of body mass index. Presented at the IDF World
Diabetes Congress, Vancouver, Canada; 30 November - 4 December 2015.
4) Ryzodeg(R) Summary of Product Characteristics (SPC). Bagsvaerd, Denmark, Novo Nordisk
A/S; April 2015.
5) Fulcher G, Christiansen JS, Bantwal G, et al; on behalf of the BOOST: Intensify Premix
I Investigators. Comparison of insulin degludec/insulin aspart and biphasic insulin
aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized,
treat-to-target trial. Diabetes Care. 2014;37(8):2084-2090.
6) De Rycke A, Mathieu C. Degludec - first of a new generation of insulins. European
Endocrinology. 2011;7(2):84-87
7) Cooper et al. Treatment intensification with IDegAsp BID vs IDeg OD plus IAsp in
insulin-treated patients with type 2 diabetes: a randomised, controlled phase 3 trial.
Diabetologia, 2014;57(Suppl 1):s69 (abstract147)
Source: Novo Nordisk
PRNewswire
- This material is not approved for Canadian journalists or Canadian audiences.
- For journalistic assessment and preparation before publication.
Abstracts 0336-P, 0337-P, 0338-P
New analyses demonstrate that Ryzodeg(R) (insulin degludec/insulin aspart) achieved successful glycaemic control with significantly lower rates of hypoglycaemia (low blood sugar) and nocturnal hypoglycaemia in patients with type 2 diabetes versus BIAsp 30 and/or a basal-bolus regimen of insulin degludec and insulin aspart[1]-[3]. These findings were presented today at the 23rd World Diabetes Congress of the International Diabetes Federation (IDF).
The analyses of pooled data from five clinical studies highlighted that these benefits were delivered to patients irrespective of baseline HbA1c, disease duration or body mass index (BMI)[1]-[3]. The results also revealed that Ryzodeg(R) versus both comparators resulted in statistically significant reductions in fasting plasma glucose (FPG), and a lower insulin dose with significant differences in patients with BMI less than or equal to30 or a disease duration longer than 10 years[1]-[3].
"Managing hypoglycaemia while also achieving optimal glycaemic control are important considerations when selecting a treatment regimen," commented Dr. Helena Rodbard, presenting author of the analyses. "These findings are especially relevant in the era of personalised medicine, and provide valuable assistance to the clinical use of Ryzodeg(R) in patients with type 2 diabetes."
These data are from the analyses of five 26-week treat-to-target phase 3a/b clinical trials in people with type 2 diabetes.
About the analyses
The post-hoc pooled analyses evaluated the efficacy and safety of Ryzodeg(R) in controlling glycaemic parameters and rates of hypoglycaemia in patients with type 2 diabetes stratified according to baseline HbA1c, disease duration and body mass index (BMI). End of trial HbA1c, FPG, insulin dose and confirmed and nocturnal confirmed hypoglycaemia were analysed in the aforementioned patient categories, according to baseline characteristics stratification: HbA1c (<7.5%, greater than or equal to7.5-<8.5%, greater than or equal to8.5-<9.0%, greater than or equal to9.0%), FPG (<5.5, >5.5-<7.0, >7.0-<10.0, >10.0 mmol/L), disease duration (less than or equal to10 or >10 years) and BMI (less than or equal to30 or >30 kg/m2)[1]-[3].
About Ryzodeg(R)
Ryzodeg(R) is a combination of two distinct insulin analogues (insulin degludec and insulin aspart in the ratio of 70% and 30%) making it the first combination of a basal insulin with a long duration of action and a well-established mealtime insulin in one pen for people with type 2 diabetes[4]-[6]. Ryzodeg(R) delivers a simple regimen with fewer injections than basal and bolus therapy[7].
Ryzodeg(R) received its first regulatory approval in December 2012, and has since been approved in more than 60 countries globally. Ryzodeg(R) was most recently approved by the U.S. Food and Drug Administration on 25 September 2015 for the treatment of diabetes mellitus in adults and is currently commercially available in India, Mexico and Bangladesh.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ] References
1) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma glucose and
hypoglycaemia rates independent of baseline HbA1c. Presented at the IDF World Diabetes
Congress, Vancouver, Canada; 30 November - 4 December 2015.
2) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma glucose and
hypoglycaemia rates independent of disease duration. Presented at the IDF World
Diabetes Congress, Vancouver, Canada; 30 November - 4 December 2015.
3) Rodbard H et al. Insulin degludec/insulin aspart lowers fasting plasma glucose and
rates of hypoglycaemia irrespective of body mass index. Presented at the IDF World
Diabetes Congress, Vancouver, Canada; 30 November - 4 December 2015.
4) Ryzodeg(R) Summary of Product Characteristics (SPC). Bagsvaerd, Denmark, Novo Nordisk
A/S; April 2015.
5) Fulcher G, Christiansen JS, Bantwal G, et al; on behalf of the BOOST: Intensify Premix
I Investigators. Comparison of insulin degludec/insulin aspart and biphasic insulin
aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized,
treat-to-target trial. Diabetes Care. 2014;37(8):2084-2090.
6) De Rycke A, Mathieu C. Degludec - first of a new generation of insulins. European
Endocrinology. 2011;7(2):84-87
7) Cooper et al. Treatment intensification with IDegAsp BID vs IDeg OD plus IAsp in
insulin-treated patients with type 2 diabetes: a randomised, controlled phase 3 trial.
Diabetologia, 2014;57(Suppl 1):s69 (abstract147)
Source: Novo Nordisk
PRNewswire
New data highlight impact of post-meal hyperglycaemia on people with diabetes
This material is intended for global medical media only.
This material is not approved for Canadian journalists or Canadian audiences.
For journalistic assessment and preparation before publication.
Abstracts: 0720-P, 0721-P, 1074-P, 0956-P
New data from four analyses[1],[2],[3],[4] demonstrate that post-meal hyperglycaemia (when blood sugar goes too high after eating) is associated with a negative physical and emotional impact on people with type 1 and type 2 diabetes[3], greater use of healthcare resources[1], missed work time and reduced productivity[4]. These results were presented today at the World Diabetes Congress of the International Diabetes Federation (IDF).
To view the Multimedia News Release, please click: http://www.multivu.com/players/uk/7700051-post-meal-hyperglycaemia-diabetes
Nearly two thirds (561 out of 906) of participants in two of the analyses experienced post-meal hyperglycaemia in the past week prior to participation in the study[1],[2] and almost one third (272 out of 906) experienced post-meal hyperglycaemia three or more times in the same period[1],[2]. Post-meal glucose control is an important contributor to achieving overall HbA1c targets[5] and, by this, helps to reduce the risk of long-term diabetes-related complications[6].
"It is important in diabetes management to get the balance right in blood glucose control. Post-meal hyperglycaemia is a persistent challenge due to the limitations of current methods of insulin delivery, yet until now there has been limited research into its implications and the experience for people living with diabetes," said Professor Simon Heller, Professor of Clinical Diabetes at Sheffield University and lead author on one of the studies. "These data support the need for more research in this area to help patients and healthcare professionals understand the importance of post-meal blood glucose control."
The experience of post-meal hyperglycaemia was associated with economic implications[1] ,[4], including an effect on working life for working people with diabetes, with 27% missing work time and 71% reporting work productivity issues[4]. In addition, those experiencing post-meal hyperglycaemia made more use of healthcare resources, having significantly greater contact with healthcare professionals (5.5 visits in the past year prior to participation in the study) compared to those not experiencing post-meal hyperglycaemia (4.4 visits in the same period)[1]. People who experienced post-meal hyperglycaemia in the past week measured their blood glucose significantly more frequently than those who did not (average extra measurement per day 1.9 vs 1.2, p<0.001)[1]. People with diabetes experiencing post-meal hyperglycaemia were also more likely to report diabetes related medical complications[1].
People with type 1 and type 2 diabetes also reported a number of daily life situations as potential contributing factors for experiencing post-meal hyperglycaemia, including stress (27%), eating out at a restaurant (25%), being busy (21%) and feeling tired (19%) [2]. The experience of post-meal hyperglycaemia was associated with a number of uncomfortable symptoms including physical impacts, such as tiredness and dizziness, emotional and cognitive impacts, sometimes leaving people with diabetes feeling demoralised, unsociable and irritable[3]. As a result, people reported an impact on a range of daily life activities, including in their working and social life, cognition and ability to drive[3].
About the studies
Three of the analyses investigated data collected from a web survey among 906 adults with type 1 (n=356) and type 2 (n=550) diabetes receiving self-administered mealtime insulin in the US (n=365), UK (n=236), and Germany (n=305). The analyses assessed the impact of respondent-reported post-meal hyperglycaemia on healthcare resource use[1], missed work and work productivity[4], and the experience of post-meal hyperglycaemia, causes, contributing situations and corrective actions following episodes[2].
The other study used a qualitative approach with one-to-one interviews and focus groups with 24 people in the UK and US aged 18 years and over with type 1 or type 2 diabetes receiving insulin therapy. Data were collected via telephone interviews and focus groups to provide insight into whether people experienced post-meal hyperglycaemia and how it affected them[3].
These studies were funded by Novo Nordisk.
About post-meal glucose
Post-meal or post-prandial glucose (also known as PPG) is the level of blood glucose concentration measured 1-2 hours after eating. It is an important factor to consider in achieving overall blood glucose control in diabetes.
The use of a mealtime insulin primarily seeks to control PPG, and therapy with a basal (long-acting) insulin primarily seeks to control blood glucose between meals and overnight, including fasting plasma glucose (FPG)[7],[8].
About post-meal hyperglycaemia
In diabetes, the body cannot produce enough or cannot respond to insulin. This means glucose can stay in the bloodstream. When blood glucose levels become too high it is known as hyperglycaemia. When blood glucose levels are higher than target levels two hours after eating, this is considered post-meal hyperglycaemia.
There is a lack of consensus between various guidelines regarding recommended PPG target levels. ADA guidelines recommend a PPG target of <10 mmol/L (180 mg/dL) to help lower HbA1c[9]. AACE/ACE guidelines recommend an out-patient target of <7.8 mmol/L (140 mg/dL) to achieve target HbA1c levels (less than or equal to6.5%), and 7.8 to 10 mmol/L (140 to 180 mg/dL) for hospitalised patients in the intensive care unit (ICU) and <10 mmol/L (180 mg/dL) for hospitalised patients not in the ICU, provided this can be done safely[10]. IDF guidelines recommend PPG be measured 1-2 hours after a meal. The target for PPG is 9.0 mmol/l (160 mg/dL), as long as hypoglycaemia is avoided[11].
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ]
References
1. Brod M, et al. Post-prandial hyperglycaemic episodes and healthcare resource use among people with diabetes in the US, UK and Germany. Research supported by Novo Nordisk. Presented at the World Diabetes Congress (Poster #0720-P), 30 November - 4 December 2015.
2. Pfeiffer KM, et al. The impact of post-prandial hyperglycaemia (PPH) on diabetes management. Research supported by Novo Nordisk. Presented at the World Diabetes Congress (Poster #1074-P), 30 November - 4 December 2015.
3. Heller S, et al. Towards a better understanding of acute post-prandial hyperglycaemic episodes: A qualitative study. Study conducted by ICON Patient Reported Outcomes under a consulting agreement with Novo Nordisk A/S. Presented at the World Diabetes Congress (Poster #0956-P), 30 November - 4 December 2015.
4. Brod M, et al. Post-prandial hyperglycaemia (PPH): Missed work time and reduced productivity among people with diabetes. Research supported by Novo Nordisk. Presented at the World Diabetes Congress (Poster #0721-P), 30 November - 4 December 2015.
5. Monnier, et al. Postprandial and basal glucose in type 2 diabetes: Assessment and respective impacts. Diabetes Technology & Therapeutics 2011;13(S1):25-32.
6. Ceriello A, et al. Guideline for management of postmeal glucose. Nutrition, Metabolism & Cardiovascular Diseases 2008;18:S17-33.
7. DeWitt DE and Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: Scientific review. JAMA 2003;289(17):2254-2264.
8. American Association of Clinical Endocrinologists (AACE). Diabetes resource centre. Treatment of Type 1 Diabetes. Available at: http://outpatient.aace.com/type1-diabetes/treatment . Last accessed: October 2015.
9. American Diabetes Association. Standards of medical care in diabetes-2015. Diabetes Care 2015;38(suppl 1):S1-S93.
10. Handelsman Y, et al. American Association of Clinical Endocrinologists and American College of Endocrinology - clinical practice guidelines for developing a diabetes mellitus comprehensive care plan - 2015. Endocrine Practice 2014;21(Suppl 1).
11. International Diabetes Federation (IDF). Guideline for Management of Post Meal Glucose in Diabetes. 2011. Available at: http://www.idf.org/sites/default/files/postmeal%20glucose%20guidelines.pdf . Last accessed: October 2015.
(Logo: http://photos.prnewswire.com/prnh/20120911/559804 )
Video: http://www.multivu.com/players/uk/7700051-post-meal-hyperglycaemia-diabetes
Source: Novo Nordisk
PRNewswire
This material is not approved for Canadian journalists or Canadian audiences.
For journalistic assessment and preparation before publication.
Abstracts: 0720-P, 0721-P, 1074-P, 0956-P
New data from four analyses[1],[2],[3],[4] demonstrate that post-meal hyperglycaemia (when blood sugar goes too high after eating) is associated with a negative physical and emotional impact on people with type 1 and type 2 diabetes[3], greater use of healthcare resources[1], missed work time and reduced productivity[4]. These results were presented today at the World Diabetes Congress of the International Diabetes Federation (IDF).
To view the Multimedia News Release, please click: http://www.multivu.com/players/uk/7700051-post-meal-hyperglycaemia-diabetes
Nearly two thirds (561 out of 906) of participants in two of the analyses experienced post-meal hyperglycaemia in the past week prior to participation in the study[1],[2] and almost one third (272 out of 906) experienced post-meal hyperglycaemia three or more times in the same period[1],[2]. Post-meal glucose control is an important contributor to achieving overall HbA1c targets[5] and, by this, helps to reduce the risk of long-term diabetes-related complications[6].
"It is important in diabetes management to get the balance right in blood glucose control. Post-meal hyperglycaemia is a persistent challenge due to the limitations of current methods of insulin delivery, yet until now there has been limited research into its implications and the experience for people living with diabetes," said Professor Simon Heller, Professor of Clinical Diabetes at Sheffield University and lead author on one of the studies. "These data support the need for more research in this area to help patients and healthcare professionals understand the importance of post-meal blood glucose control."
The experience of post-meal hyperglycaemia was associated with economic implications[1] ,[4], including an effect on working life for working people with diabetes, with 27% missing work time and 71% reporting work productivity issues[4]. In addition, those experiencing post-meal hyperglycaemia made more use of healthcare resources, having significantly greater contact with healthcare professionals (5.5 visits in the past year prior to participation in the study) compared to those not experiencing post-meal hyperglycaemia (4.4 visits in the same period)[1]. People who experienced post-meal hyperglycaemia in the past week measured their blood glucose significantly more frequently than those who did not (average extra measurement per day 1.9 vs 1.2, p<0.001)[1]. People with diabetes experiencing post-meal hyperglycaemia were also more likely to report diabetes related medical complications[1].
People with type 1 and type 2 diabetes also reported a number of daily life situations as potential contributing factors for experiencing post-meal hyperglycaemia, including stress (27%), eating out at a restaurant (25%), being busy (21%) and feeling tired (19%) [2]. The experience of post-meal hyperglycaemia was associated with a number of uncomfortable symptoms including physical impacts, such as tiredness and dizziness, emotional and cognitive impacts, sometimes leaving people with diabetes feeling demoralised, unsociable and irritable[3]. As a result, people reported an impact on a range of daily life activities, including in their working and social life, cognition and ability to drive[3].
About the studies
Three of the analyses investigated data collected from a web survey among 906 adults with type 1 (n=356) and type 2 (n=550) diabetes receiving self-administered mealtime insulin in the US (n=365), UK (n=236), and Germany (n=305). The analyses assessed the impact of respondent-reported post-meal hyperglycaemia on healthcare resource use[1], missed work and work productivity[4], and the experience of post-meal hyperglycaemia, causes, contributing situations and corrective actions following episodes[2].
The other study used a qualitative approach with one-to-one interviews and focus groups with 24 people in the UK and US aged 18 years and over with type 1 or type 2 diabetes receiving insulin therapy. Data were collected via telephone interviews and focus groups to provide insight into whether people experienced post-meal hyperglycaemia and how it affected them[3].
These studies were funded by Novo Nordisk.
About post-meal glucose
Post-meal or post-prandial glucose (also known as PPG) is the level of blood glucose concentration measured 1-2 hours after eating. It is an important factor to consider in achieving overall blood glucose control in diabetes.
The use of a mealtime insulin primarily seeks to control PPG, and therapy with a basal (long-acting) insulin primarily seeks to control blood glucose between meals and overnight, including fasting plasma glucose (FPG)[7],[8].
About post-meal hyperglycaemia
In diabetes, the body cannot produce enough or cannot respond to insulin. This means glucose can stay in the bloodstream. When blood glucose levels become too high it is known as hyperglycaemia. When blood glucose levels are higher than target levels two hours after eating, this is considered post-meal hyperglycaemia.
There is a lack of consensus between various guidelines regarding recommended PPG target levels. ADA guidelines recommend a PPG target of <10 mmol/L (180 mg/dL) to help lower HbA1c[9]. AACE/ACE guidelines recommend an out-patient target of <7.8 mmol/L (140 mg/dL) to achieve target HbA1c levels (less than or equal to6.5%), and 7.8 to 10 mmol/L (140 to 180 mg/dL) for hospitalised patients in the intensive care unit (ICU) and <10 mmol/L (180 mg/dL) for hospitalised patients not in the ICU, provided this can be done safely[10]. IDF guidelines recommend PPG be measured 1-2 hours after a meal. The target for PPG is 9.0 mmol/l (160 mg/dL), as long as hypoglycaemia is avoided[11].
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ]
References
1. Brod M, et al. Post-prandial hyperglycaemic episodes and healthcare resource use among people with diabetes in the US, UK and Germany. Research supported by Novo Nordisk. Presented at the World Diabetes Congress (Poster #0720-P), 30 November - 4 December 2015.
2. Pfeiffer KM, et al. The impact of post-prandial hyperglycaemia (PPH) on diabetes management. Research supported by Novo Nordisk. Presented at the World Diabetes Congress (Poster #1074-P), 30 November - 4 December 2015.
3. Heller S, et al. Towards a better understanding of acute post-prandial hyperglycaemic episodes: A qualitative study. Study conducted by ICON Patient Reported Outcomes under a consulting agreement with Novo Nordisk A/S. Presented at the World Diabetes Congress (Poster #0956-P), 30 November - 4 December 2015.
4. Brod M, et al. Post-prandial hyperglycaemia (PPH): Missed work time and reduced productivity among people with diabetes. Research supported by Novo Nordisk. Presented at the World Diabetes Congress (Poster #0721-P), 30 November - 4 December 2015.
5. Monnier, et al. Postprandial and basal glucose in type 2 diabetes: Assessment and respective impacts. Diabetes Technology & Therapeutics 2011;13(S1):25-32.
6. Ceriello A, et al. Guideline for management of postmeal glucose. Nutrition, Metabolism & Cardiovascular Diseases 2008;18:S17-33.
7. DeWitt DE and Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: Scientific review. JAMA 2003;289(17):2254-2264.
8. American Association of Clinical Endocrinologists (AACE). Diabetes resource centre. Treatment of Type 1 Diabetes. Available at: http://outpatient.aace.com/type1-diabetes/treatment . Last accessed: October 2015.
9. American Diabetes Association. Standards of medical care in diabetes-2015. Diabetes Care 2015;38(suppl 1):S1-S93.
10. Handelsman Y, et al. American Association of Clinical Endocrinologists and American College of Endocrinology - clinical practice guidelines for developing a diabetes mellitus comprehensive care plan - 2015. Endocrine Practice 2014;21(Suppl 1).
11. International Diabetes Federation (IDF). Guideline for Management of Post Meal Glucose in Diabetes. 2011. Available at: http://www.idf.org/sites/default/files/postmeal%20glucose%20guidelines.pdf . Last accessed: October 2015.
(Logo: http://photos.prnewswire.com/prnh/20120911/559804 )
Video: http://www.multivu.com/players/uk/7700051-post-meal-hyperglycaemia-diabetes
Source: Novo Nordisk
PRNewswire
Victoza(R) (liraglutide) provides greater glycaemic control than SGLT-2 inhibitors
This material is intended for global medical media only.
This material is not approved for Canadian journalists or Canadian audiences.
For journalistic assessment and preparation before publication.
New findings from a network meta-analysis show that treatment with Victoza(R) (liraglutide) provides a greater HbA1c reduction and an improved likelihood of reaching glycaemic goals compared to sodium-glucose co-transporter 2 (SGLT-2) inhibitors in people with type 2 diabetes who are inadequately controlled with metformin alone or in combination with sulfonylurea, dipeptidyl peptidase-4 (DPP-4) inhibitors or thiazolidinedione.[1] Findings were presented today at the World Diabetes Congress of the International Diabetes Federation (IDF) in Vancouver, Canada.
The meta-analysis evaluated the relative efficacy of Victoza(R) to SGLT-2 inhibitors, including canagliflozin, empagliflozin and dapagliflozin.[1] In an analysis of 17 randomised controlled trials (RCTs), Victoza(R) demonstrated greater reductions in mean HbA1c compared to all SGLT-2 inhibitors (placebo-adjusted mean change -1.01%/-1.18% for Victoza(R) 1.2 mg/1.8 mg; -0.64%/-0.79% for canagliflozin 100 mg/300 mg; -0.32%/-0.38% for dapagliflozin 5 mg/10 mg; -0.59%/-0.62% for empagliflozin 10 mg/25 mg).[1]
"In the absence of head-to-head trials, this analysis provides valuable insight into the comparative outcomes with liraglutide versus SGLT-2 inhibitors in people with type 2 diabetes uncontrolled on oral antidiabetic treatments," said Maria Lorenzi, MSc, lead author and research manager, Redwood Outcomes, CA, US.
The networks of evidence analysed to evaluate the relative efficacy of Victoza(R) compared with approved SGLT-2 inhibitors were based on available data from RCTs that were published when the meta-analysis was initiated.
About network meta-analyses
In network meta-analyses (NMA), multiple treatments are included, using data from trials that compare at least two of these treatments. A NMA offers the advantage of being able to compare any treatments included in the network, including those that have not been compared directly, and, in the right circumstances, allows the full set of treatments to be ranked.[2] As with any NMA, some of the indirect comparisons in the Victoza(R) compared to SGLT-2 inhibitors NMA may be biased due to differences in patient characteristics between trials, most notably duration of diabetes, and the number of concomitant oral antidiabetic drugs.
About Victoza(R)
Victoza(R) (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza(R) works by stimulating the beta-cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza(R) is associated with a low rate of hypoglycaemia.*[3] In addition, Victoza(R) reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered energy intake.[3]
Victoza(R) was launched in the EU in 2009 and is commercially available in more than 80 countries with more than three million patient years of use in people with type 2 diabetes globally.[3],[4] In Europe, Victoza(R) is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.[3]
*Hypoglycaemia has primarily been observed when Victoza(R) is combined with a sulfonylurea or basal insulin.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube. [http://www.youtube.com/novonordisk ]
Further information
Media:
Katrine Sperling
+45 4442 6718
krsp@novonordisk.com
Asa Josefsson
+45 3079 7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45 3075 9085
phak@novonordisk.com
Melanie Raouzeos
+45 3075 3479
mrz@novonordisk.com
Daniel Bohsen
+45 3079 6376
dabo@novonordisk.com
Kasper Veje
+45 3079 8519
kpvj@novonordisk.com
Frank Daniel Mersebach (US)
+1 609 235 8567
fdni@novonordisk.com
References
1) Lorenzi M, Ploug U, Langer J, et al. Liraglutide vs SGLT-2 inhibitors in people with type 2 diabetes: a network meta-analysis. Presented at 23rd World Diabetes Congress, Vancouver, BC, Canada; 30 November - 4 December 2015. Abstract number 0226-P.
2) Jackson D, Barrett J, Rice S, et al. A design-by-treatment interaction model for network meta-analysis with random inconsistency effects. Stat Med. 2014; 33:3639-3654.
3) EMA. Victoza(R) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf Last accessed October 2015.
4) Internal Calculations based on IMS Midas Quantum data. September 2015.
Source: Novo Nordisk
PRNewswire
This material is not approved for Canadian journalists or Canadian audiences.
For journalistic assessment and preparation before publication.
New findings from a network meta-analysis show that treatment with Victoza(R) (liraglutide) provides a greater HbA1c reduction and an improved likelihood of reaching glycaemic goals compared to sodium-glucose co-transporter 2 (SGLT-2) inhibitors in people with type 2 diabetes who are inadequately controlled with metformin alone or in combination with sulfonylurea, dipeptidyl peptidase-4 (DPP-4) inhibitors or thiazolidinedione.[1] Findings were presented today at the World Diabetes Congress of the International Diabetes Federation (IDF) in Vancouver, Canada.
The meta-analysis evaluated the relative efficacy of Victoza(R) to SGLT-2 inhibitors, including canagliflozin, empagliflozin and dapagliflozin.[1] In an analysis of 17 randomised controlled trials (RCTs), Victoza(R) demonstrated greater reductions in mean HbA1c compared to all SGLT-2 inhibitors (placebo-adjusted mean change -1.01%/-1.18% for Victoza(R) 1.2 mg/1.8 mg; -0.64%/-0.79% for canagliflozin 100 mg/300 mg; -0.32%/-0.38% for dapagliflozin 5 mg/10 mg; -0.59%/-0.62% for empagliflozin 10 mg/25 mg).[1]
"In the absence of head-to-head trials, this analysis provides valuable insight into the comparative outcomes with liraglutide versus SGLT-2 inhibitors in people with type 2 diabetes uncontrolled on oral antidiabetic treatments," said Maria Lorenzi, MSc, lead author and research manager, Redwood Outcomes, CA, US.
The networks of evidence analysed to evaluate the relative efficacy of Victoza(R) compared with approved SGLT-2 inhibitors were based on available data from RCTs that were published when the meta-analysis was initiated.
About network meta-analyses
In network meta-analyses (NMA), multiple treatments are included, using data from trials that compare at least two of these treatments. A NMA offers the advantage of being able to compare any treatments included in the network, including those that have not been compared directly, and, in the right circumstances, allows the full set of treatments to be ranked.[2] As with any NMA, some of the indirect comparisons in the Victoza(R) compared to SGLT-2 inhibitors NMA may be biased due to differences in patient characteristics between trials, most notably duration of diabetes, and the number of concomitant oral antidiabetic drugs.
About Victoza(R)
Victoza(R) (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza(R) works by stimulating the beta-cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza(R) is associated with a low rate of hypoglycaemia.*[3] In addition, Victoza(R) reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered energy intake.[3]
Victoza(R) was launched in the EU in 2009 and is commercially available in more than 80 countries with more than three million patient years of use in people with type 2 diabetes globally.[3],[4] In Europe, Victoza(R) is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.[3]
*Hypoglycaemia has primarily been observed when Victoza(R) is combined with a sulfonylurea or basal insulin.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://www.novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube. [http://www.youtube.com/novonordisk ]
Further information
Media:
Katrine Sperling
+45 4442 6718
krsp@novonordisk.com
Asa Josefsson
+45 3079 7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45 3075 9085
phak@novonordisk.com
Melanie Raouzeos
+45 3075 3479
mrz@novonordisk.com
Daniel Bohsen
+45 3079 6376
dabo@novonordisk.com
Kasper Veje
+45 3079 8519
kpvj@novonordisk.com
Frank Daniel Mersebach (US)
+1 609 235 8567
fdni@novonordisk.com
References
1) Lorenzi M, Ploug U, Langer J, et al. Liraglutide vs SGLT-2 inhibitors in people with type 2 diabetes: a network meta-analysis. Presented at 23rd World Diabetes Congress, Vancouver, BC, Canada; 30 November - 4 December 2015. Abstract number 0226-P.
2) Jackson D, Barrett J, Rice S, et al. A design-by-treatment interaction model for network meta-analysis with random inconsistency effects. Stat Med. 2014; 33:3639-3654.
3) EMA. Victoza(R) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf Last accessed October 2015.
4) Internal Calculations based on IMS Midas Quantum data. September 2015.
Source: Novo Nordisk
PRNewswire
Monday, November 16, 2015
Victoza(R) (liraglutide) is cost-effective vs. lixisenatide and cost-saving vs. exenatide in the UK
Abstract: PDB54 B20
New findings from a health economics and outcomes research (HEOR) analysis demonstrated that Victoza(R) (liraglutide) 1.2 mg is cost-effective for the treatment of type 2 diabetes in the UK market when compared to lixisenatide and is cost-saving compared to exenatide.[1] Findings were presented today at the 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Milan, Italy.
The analysis assessed the cost-effectiveness of liraglutide (1.2 mg), exenatide (10 microg BID) and lixisenatide (20 microg), prescribed for the treatment of type 2 diabetes in the UK. Liraglutide (1.2 mg) was found to be cost-effective versus lixisenatide, with an incremental cost-effectiveness ratio (ICER)* of GBP7,367 per QALY* gained. Liraglutide (1.2 mg) was associated with cost-savings of GBP87 versus exenatide 10 mug BID.
"As the population with type 2 diabetes increases, it is vital that cost-effective medications such as liraglutide are available to help improve patients' quality of life and prevent complications," said Dr Klaus Henning Jensen, Head of Clinical, Medical and Regulatory at Novo Nordisk, UK & Ireland.
The analysis was based on changes seen in blood glucose level (HbA1c), blood pressure and body mass index on initiation of each treatment, taken from a network meta-analysis of 13 randomized controlled trials. These trials evaluated the efficacy and safety of GLP-1 receptor agonists for the treatment of people with type 2 diabetes uncontrolled on oral antidiabetic drugs.[1]
* An ICER calculation is used to quantify the additional benefit gained from an intervention and its associated cost.
* Quality-adjusted life year (QALY) is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to one year of life in perfect health.
About Victoza(R)
Victoza(R) (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza(R) works by stimulating the beta-cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza(R) is associated with a low rate of hypoglycaemia.[Section], [2] In addition, Victoza(R) reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered energy intake.[2]
Victoza(R) was launched in the EU in 2009 and is commercially available in more than 80 countries with more than 3 million patient years of use in people with type 2 diabetes globally.[2],[3] In Europe, Victoza(R) is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.[2]
Section Hypoglycaemia has primarily been observed when Victoza(R) is combined with a sulfonylurea or a basal insulin.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ]
References
1. Ashley D, Vega G, Hunt B, et al. Evaluating the cost-effectiveness of GLP-1 receptor agonists for the treatment of type 2 diabetes in the UK. PDB 54: B20. 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Milan, Italy, 7-11 November 2015.
2. EMA. Victoza(R) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf Last accessed October 2015.
3. Internal Calculations based on IMS Midas Quantum data. April 2015.
Further information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-3079-7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Kasper Veje
+45-3079-8519
kpvj@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Source: Novo Nordisk
PRNewswire
New findings from a health economics and outcomes research (HEOR) analysis demonstrated that Victoza(R) (liraglutide) 1.2 mg is cost-effective for the treatment of type 2 diabetes in the UK market when compared to lixisenatide and is cost-saving compared to exenatide.[1] Findings were presented today at the 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Milan, Italy.
The analysis assessed the cost-effectiveness of liraglutide (1.2 mg), exenatide (10 microg BID) and lixisenatide (20 microg), prescribed for the treatment of type 2 diabetes in the UK. Liraglutide (1.2 mg) was found to be cost-effective versus lixisenatide, with an incremental cost-effectiveness ratio (ICER)* of GBP7,367 per QALY* gained. Liraglutide (1.2 mg) was associated with cost-savings of GBP87 versus exenatide 10 mug BID.
"As the population with type 2 diabetes increases, it is vital that cost-effective medications such as liraglutide are available to help improve patients' quality of life and prevent complications," said Dr Klaus Henning Jensen, Head of Clinical, Medical and Regulatory at Novo Nordisk, UK & Ireland.
The analysis was based on changes seen in blood glucose level (HbA1c), blood pressure and body mass index on initiation of each treatment, taken from a network meta-analysis of 13 randomized controlled trials. These trials evaluated the efficacy and safety of GLP-1 receptor agonists for the treatment of people with type 2 diabetes uncontrolled on oral antidiabetic drugs.[1]
* An ICER calculation is used to quantify the additional benefit gained from an intervention and its associated cost.
* Quality-adjusted life year (QALY) is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to one year of life in perfect health.
About Victoza(R)
Victoza(R) (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza(R) works by stimulating the beta-cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza(R) is associated with a low rate of hypoglycaemia.[Section], [2] In addition, Victoza(R) reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered energy intake.[2]
Victoza(R) was launched in the EU in 2009 and is commercially available in more than 80 countries with more than 3 million patient years of use in people with type 2 diabetes globally.[2],[3] In Europe, Victoza(R) is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.[2]
Section Hypoglycaemia has primarily been observed when Victoza(R) is combined with a sulfonylurea or a basal insulin.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://novonordisk.com ], Facebook [http://www.facebook.com/novonordisk ], Twitter [http://www.twitter.com/novonordisk ], LinkedIn [http://www.linkedin.com/company/novo-nordisk ], YouTube [http://www.Youtube.com/novonordisk ]
References
1. Ashley D, Vega G, Hunt B, et al. Evaluating the cost-effectiveness of GLP-1 receptor agonists for the treatment of type 2 diabetes in the UK. PDB 54: B20. 18th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Milan, Italy, 7-11 November 2015.
2. EMA. Victoza(R) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf Last accessed October 2015.
3. Internal Calculations based on IMS Midas Quantum data. April 2015.
Further information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-3079-7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Kasper Veje
+45-3079-8519
kpvj@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Source: Novo Nordisk
PRNewswire
Monday, September 21, 2015
Victoza(R) (liraglutide) Provides Significantly Greater HbA1c Reduction than Lixisenatide in New Clinical Trial
This material is intended for global medical media only.
For journalistic assessment and preparation before publication.
Abstract #75
Findings from a head-to-head trial comparing Victoza(R) (liraglutide) and lixisenatide, both in combination with metformin, demonstrated a significantly greater reduction in HbA1c of -1.83% for liraglutide vs -1.21% for lixisenatide in adults with type 2 diabetes.[1]Results from the LIRA-LIXI trial were announced today in an oral presentation at the 51st Annual Meeting of the European Association for the Study of Diabetes (EASD) in Stockholm, Sweden.
The 26-week LIRA-LIXI trial compared the efficacy and safety of Victoza(R) versus lixisenatide, both as add-on to metformin in 404 people with type 2 diabetes.[1] People with type 2 diabetes treated with Victoza(R) achieved a significantly greater reduction in HbA1c versus lixisenatide at 26 weeks, meeting the trial's primary endpoint (-1.83% vs -1.21%; estimated treatment difference [ETD] -0.62% [-0.80; -0.44]; P<0.0001).[1] In addition, more people treated with Victoza(R) achieved HbA1c targets of <7% (74.2% vs 45.5%; odds ratio (OR) 4.16; [2.58; 6.73]; P<0.0001)[1] and less than or equal to6.5% (54.6% vs 26.2%; OR 3.66; [2.31; 5.81]; P<0.0001) compared with lixisenatide.[1]
"The significant difference in blood glucose control between liraglutide and lixisenatide reported in the LIRA-LIXI trial reinforces the value of liraglutide as an efficacious treatment for those with type 2 diabetes otherwise treated with oral glucose-lowering drugs," said Professor Michael A Nauck, director and diabetologist, Division of Diabetology, St. Josef Hospital, Ruhr-University Bochum, Germany and principal investigator of the LIRA-LIXI trial. "Many people living with type 2 diabetes remain uncontrolled and it is crucial for these patients to gain control of their blood glucose levels to help prevent further complications from this disease."
Furthermore, Victoza(R) demonstrated significantly greater reductions in fasting plasma glucose (-2.85 mmol/L vs -1.70 mmol/L; ETD -1.15 mmol/L [95% CI -1.51; -0.80] ; P<0.0001) and mean 9-point self-measured plasma glucose (-2.64 mmol/L vs. -1.89 mmol/L; ETD -0.75 mmol/L [95% CI -1.08; -0.42]; P<0.0001) compared with lixisenatide.[1] Lixisenatide, however, had smaller postprandial increments for the meal following injection compared to Victoza(R) (morning meal: -2.12 mmol/L vs -0.88 mmol/L; ETD 1.24 mmol/L; [0.69; 1.79]; P<0.0001; and evening meal: -1.88 mmol/L vs -0.53 mmol/L; ETD 1.36 mmol/L; [0.44; 2.27];P=0.0039).[1]
Weight loss was observed in both treatment groups (Victoza(R): -4.26 kg vs lixisenatide: -3.67 kg; ETD -0.59 kg [-1.55; 0.38]; P=0.2347).[1] Systolic and diastolic blood pressure decreased with both Victoza(R) and lixisenatide treatment (systolic blood pressure: -4.70 mmHg vs -3.49 mmHg; ETD -1.21 mmHg [-3.87; 1.45]; P=0.3722; diastolic blood pressure: -2.62 mmHg vs -2.69 mmHg; ETD 0.07 mmHg [-1.53; 1.67];P=0.9318, respectively).[1]
The safety profile in the LIRA-LIXI trial was similar between the two treatment groups. The most common adverse events were gastrointestinal, which included nausea and diarrhoea. No severe hypoglycaemic episodes were reported.[1]
About the LIRA-LIXI Trial
The trial was a 26-week, parallel group, open-label trial involving 404 adults with type 2 diabetes randomised 1:1.[1] The trial participants were randomised to Victoza(R) 1.8 mg or lixisenatide 20 microg, both as add-on to metformin (at maximum tolerated dose, 1000?3000 mg daily).[1] Dose escalation and administration of Victoza(R) and lixisenatide were according to the approved label for both drugs at the time of the trial.[1] Victoza(R) was administered once-daily at any time of the day irrespective of meals. Lixisenatide was administered once-daily within an hour prior to the morning or evening meal.[1]
About Victoza(R)
Victoza(R) (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza(R) works by stimulating the beta-cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza(R) is associated with a low rate of hypoglycaemia.[*],[2] In addition, Victoza(R) reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered energy intake.[2]
Victoza(R) was launched in the EU in 2009 and is commercially available in more than 80 countries with more than 3 million patient years of use in people with type 2 diabetes globally.[2],[3] In Europe, Victoza(R) is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.[2]
[*]Hypoglycaemia has primarily been observed when Victoza(R) is combined with a sulfonylurea or basal insulin.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube .
References
1. Nauck M, Rizzo M, Pirags V, et al. Once-daily liraglutide vs. lixisenatide as add-on to metformin in type 2 diabetes: a 26-week randomised controlled clinical trial. Oral presentation. Abstract number 75. 51st Annual Meeting of the European Association of Diabetes (EASD). 2015
2. EMA. Victoza(R) EU Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Product_Information/human/001026/WC500050017.pdf Last accessed 17.06.2015.
3. Internal Calculations based on IMS Midas Quantum data. April 2015.
Further information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-30797708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Source: Novo Nordisk
PR Newswire
Friday, September 18, 2015
New Data on Saxenda(R) Show Early Response Predicts Improvements in Weight Loss and Cardiometabolic Risk Factors
This material is intended for global medical media only.
For journalistic assessment and preparation before publication
Abstract #645
Today, new data from a post-hoc analysis of the phase 3a SCALE(TM) clinical development programme were presented at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting.[1] The data demonstrated that adults in the SCALE(TM) Obesity and Prediabetes and SCALE(TM) Diabetes trials who lost at least 5% of their body weight after completing 16 weeks of Saxenda(R) (liraglutide 3 mg) treatment (defined as 'early responders') had greater weight loss after completing 56 weeks, compared with people losing less than 5% body weight with Saxenda(R) after completing 16 weeks ('early non-responders'). All treatment groups included a reduced-calorie diet and increased physical activity.[1]
"These data demonstrate the importance of identifying those adults who respond early to Saxenda(R)," said Professor Matthias Bluher, head of the obesity outpatient clinic at the University of Leipzig, Germany, and SCALE(TM) trial investigator. "Not only are these Saxenda(R) early responders more likely to achieve greater weight loss over time, they are also more likely to experience greater improvements in cardiometabolic risk factors."
After completing 16 weeks of the SCALE(TM) Obesity and Prediabetes trial, 67.5% of adults with obesity or who were overweight with weight-related comorbidities (excluding type 2 diabetes), were early responders to Saxenda(R) (n=2487) and experienced an average weight loss of 11.5% after completing 56 weeks of treatment, compared with a weight loss of 3.8% for early non-responders. The proportion of early responders losing greater than or equal to5%, >10% and >15% of their bodyweight after completing 56 weeks was 88.2%, 54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early non-responders).
After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults with obesity or who were overweight and had type 2 diabetes, were early responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after completing 56 weeks of treatment compared with a weight loss of 3.6% for early non-responders. The proportion of early responders experiencing greater than or equal to5%, >10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]
Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]
The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.
About obesity
Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]
About Saxenda(R)
Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.
Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.[10]
Saxenda(R) was approved by the FDA on 23 December 2014 and Health Canada on 26 February 2015. Please refer to local label for further information.
Guidance is given in all labels that treatment with Saxenda(R) should be discontinued if a specific threshold of weight loss has not been achieved after a certain period of time.
About the SCALE(TM) clinical development programme
Novo Nordisk's phase 3 development programme, called SCALE(TM), investigates liraglutide 3 mg for weight management. SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Non-diabetic and Diabetic people) consists of four, placebo-controlled, multinational trials called: SCALE(TM) Obesity and Prediabetes, SCALE (TM) Diabetes, SCALE(TM) Sleep Apnoea and SCALE(TM) Maintenance. The trials include more than 5,000 people who are overweight (BMI greater than or equal to27 kg/m2) with comorbidities such as hypertension, dyslipidaemia, obstructive sleep apnoea (OSA) or type 2 diabetes, or who have obesity (BMI greater than or equal to30 kg/m2), with or without comorbidities. The studies all involved a reduced-calorie diet and increased physical activity.
Key results from all trials in the SCALE(TM) clinical development programme have been published, with further data expected to be presented and published in 2015.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
References
1. Bluher F, Hermansen K, Greenway F, et al. Early weight loss with liraglutide 3.0 mg is a good predictor of clinically meaningful weight loss after 56 weeks. 51st EASD Annual Meeting 2015.
2. American Medical Association A. Declaration to classify obesity as a disease. Annual Meeting Report. 19 June 2013.
3. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009; 9:88.
4. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Annals of Internal Medicine. 2003; 138:24-32.
5. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep apnea. Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.
6. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009; 373:1083-1096.
7. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging. 2012; 37:730-732.
8. WHO. Obesity Data and Statistics (Europe). Available at: http://www.euro.who.int/en/health-topics/noncommunicable-diseases/obesity/data-and-statistics (Last accessed 21.08.15).
9. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. Journal of Medicinal Chemistry. 2000; 43:1664-1669.
10. EMA. Saxenda(R) (liraglutide 3 mg) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/0037 80/WC500185786.pdf (Made available: 16 April 2015).
Further information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-3079-7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Source: Novo Nordisk
For journalistic assessment and preparation before publication
Abstract #645
Today, new data from a post-hoc analysis of the phase 3a SCALE(TM) clinical development programme were presented at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting.[1] The data demonstrated that adults in the SCALE(TM) Obesity and Prediabetes and SCALE(TM) Diabetes trials who lost at least 5% of their body weight after completing 16 weeks of Saxenda(R) (liraglutide 3 mg) treatment (defined as 'early responders') had greater weight loss after completing 56 weeks, compared with people losing less than 5% body weight with Saxenda(R) after completing 16 weeks ('early non-responders'). All treatment groups included a reduced-calorie diet and increased physical activity.[1]
"These data demonstrate the importance of identifying those adults who respond early to Saxenda(R)," said Professor Matthias Bluher, head of the obesity outpatient clinic at the University of Leipzig, Germany, and SCALE(TM) trial investigator. "Not only are these Saxenda(R) early responders more likely to achieve greater weight loss over time, they are also more likely to experience greater improvements in cardiometabolic risk factors."
After completing 16 weeks of the SCALE(TM) Obesity and Prediabetes trial, 67.5% of adults with obesity or who were overweight with weight-related comorbidities (excluding type 2 diabetes), were early responders to Saxenda(R) (n=2487) and experienced an average weight loss of 11.5% after completing 56 weeks of treatment, compared with a weight loss of 3.8% for early non-responders. The proportion of early responders losing greater than or equal to5%, >10% and >15% of their bodyweight after completing 56 weeks was 88.2%, 54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early non-responders).
After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults with obesity or who were overweight and had type 2 diabetes, were early responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after completing 56 weeks of treatment compared with a weight loss of 3.6% for early non-responders. The proportion of early responders experiencing greater than or equal to5%, >10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).[1]
Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.[1]
The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively).[1] In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.
About obesity
Obesity is a disease[2] that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy.[3],[4] Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.[3],[5],[6] It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.[7]
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.[8]
About Saxenda(R)
Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake.[9] Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.[10] These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.
Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.[10]
Saxenda(R) was approved by the FDA on 23 December 2014 and Health Canada on 26 February 2015. Please refer to local label for further information.
Guidance is given in all labels that treatment with Saxenda(R) should be discontinued if a specific threshold of weight loss has not been achieved after a certain period of time.
About the SCALE(TM) clinical development programme
Novo Nordisk's phase 3 development programme, called SCALE(TM), investigates liraglutide 3 mg for weight management. SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Non-diabetic and Diabetic people) consists of four, placebo-controlled, multinational trials called: SCALE(TM) Obesity and Prediabetes, SCALE (TM) Diabetes, SCALE(TM) Sleep Apnoea and SCALE(TM) Maintenance. The trials include more than 5,000 people who are overweight (BMI greater than or equal to27 kg/m2) with comorbidities such as hypertension, dyslipidaemia, obstructive sleep apnoea (OSA) or type 2 diabetes, or who have obesity (BMI greater than or equal to30 kg/m2), with or without comorbidities. The studies all involved a reduced-calorie diet and increased physical activity.
Key results from all trials in the SCALE(TM) clinical development programme have been published, with further data expected to be presented and published in 2015.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
References
1. Bluher F, Hermansen K, Greenway F, et al. Early weight loss with liraglutide 3.0 mg is a good predictor of clinically meaningful weight loss after 56 weeks. 51st EASD Annual Meeting 2015.
2. American Medical Association A. Declaration to classify obesity as a disease. Annual Meeting Report. 19 June 2013.
3. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009; 9:88.
4. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Annals of Internal Medicine. 2003; 138:24-32.
5. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep apnea. Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.
6. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009; 373:1083-1096.
7. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging. 2012; 37:730-732.
8. WHO. Obesity Data and Statistics (Europe). Available at: http://www.euro.who.int/en/health-topics/noncommunicable-diseases/obesity/data-and-statistics (Last accessed 21.08.15).
9. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. Journal of Medicinal Chemistry. 2000; 43:1664-1669.
10. EMA. Saxenda(R) (liraglutide 3 mg) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/0037 80/WC500185786.pdf (Made available: 16 April 2015).
Further information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-3079-7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Source: Novo Nordisk
PRNewswire
New Study Shows Different Perceptions of Control Among Physicians and Patients May Lead to Suboptimal Type 2 Diabetes Management
Results presented today at the European Association for the Study of Diabetes (EASD) showed that increased awareness about how patients' and physicians' perceptions of control differ, could benefit physician-patient communication and improve diabetes management.[1] New findings from the Perceptions of Control (POC) study showed adults with type 2 diabetes uncontrolled on basal insulin had a broader definition of control, perceived greater obstacles to maintaining control and that life was impacted significantly more than physicians expected.[1]
To view the Multimedia News Release, please click:
http://www.multivu.com/players/English/7625651-study-perceptions-type-2-diabetes/
"There is a significant gap in perceptions of control between physicians and patients in how they define control, the obstacles and how being uncontrolled on basal insulin impacts patients' daily lives," said Meryl Brod, PhD, lead investigator of the POC research study. "Having a more open dialogue during consultations may provide more insight into these critical factors which could improve diabetes management and lead to more effective individualised treatment plans."
The study identified that physicians defined control in measurable, clinical terms such as frequency/severity of hypoglycaemia (93% vs 69%, p<0.001), complications (89% vs 75%, p<0.001) and HbA1c (85% vs 79%, p<0.05) versus patients uncontrolled on basal insulin respectively.[1] Although these clinical measures were important to people with type 2 diabetes, their definitions of control had a much broader focus than physicians and included the amount of insulin (units) taken per day (78% vs 29%, p<0.001), energy levels (75% vs 33%, p<0.001) and how much they have to think about their disease (68% vs 31%, p<0.001) amongst other factors.[1]
People with type 2 diabetes uncontrolled on basal insulin perceived more obstacles to achieving control compared to physicians, including stress (75% vs 54%, p<0.001), medicine side-effects (70% vs 56%, p<0.001) and a lack of patient support groups (56% vs 11%, p<0.001).[1]
The impact of being uncontrolled on basal insulin and how it interfered in one's life was perceived as significantly greater than physicians believed including aspects such as mood/emotions (63% vs 33%, p<0.001), making plans (62% vs 16%, p<0.001) and how much one accomplished during the day (62% vs 23% p<0.001) amongst other factors.[1]
About the Perception of Control (POC) Study
The POC study was based on information collected from a web survey of 300 physicians and 1,012 adults with type 2 diabetes uncontrolled on basal insulin (physician-confirmed HbA1c> 8% (64 mmol/mol)) from the UK (n=100 physicians and 620 patients), Sweden (n=100 physicians and 240 patients) and Switzerland (n=100 physicians and 152 patients).[1] Information was also collected from a control group of 295 adults with type 2 diabetes controlled on basal insulin (physician-confirmed HbA1c <7.5% (59 mmol/mol) from the UK.[1] In total, data were collected from 1,607 patients and physicians for analysis. The purpose of the study was to investigate how this patient population perceived control and whether it differed from perceptions of control among physicians.[1]
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
Further Information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-3079-7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Reference
1. Brod M, et al. Perceptions of diabetes control among physicians and patients with uncontrolled type 2 diabetes using basal insulin. Poster presentation (#890) at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting, 16 September 2015.
Video: http://www.multivu.com/players/English/7625651-study-perceptions-type-2-diabetes/
Source: Novo Nordisk
PRNewswire
To view the Multimedia News Release, please click:
http://www.multivu.com/players/English/7625651-study-perceptions-type-2-diabetes/
"There is a significant gap in perceptions of control between physicians and patients in how they define control, the obstacles and how being uncontrolled on basal insulin impacts patients' daily lives," said Meryl Brod, PhD, lead investigator of the POC research study. "Having a more open dialogue during consultations may provide more insight into these critical factors which could improve diabetes management and lead to more effective individualised treatment plans."
The study identified that physicians defined control in measurable, clinical terms such as frequency/severity of hypoglycaemia (93% vs 69%, p<0.001), complications (89% vs 75%, p<0.001) and HbA1c (85% vs 79%, p<0.05) versus patients uncontrolled on basal insulin respectively.[1] Although these clinical measures were important to people with type 2 diabetes, their definitions of control had a much broader focus than physicians and included the amount of insulin (units) taken per day (78% vs 29%, p<0.001), energy levels (75% vs 33%, p<0.001) and how much they have to think about their disease (68% vs 31%, p<0.001) amongst other factors.[1]
People with type 2 diabetes uncontrolled on basal insulin perceived more obstacles to achieving control compared to physicians, including stress (75% vs 54%, p<0.001), medicine side-effects (70% vs 56%, p<0.001) and a lack of patient support groups (56% vs 11%, p<0.001).[1]
The impact of being uncontrolled on basal insulin and how it interfered in one's life was perceived as significantly greater than physicians believed including aspects such as mood/emotions (63% vs 33%, p<0.001), making plans (62% vs 16%, p<0.001) and how much one accomplished during the day (62% vs 23% p<0.001) amongst other factors.[1]
About the Perception of Control (POC) Study
The POC study was based on information collected from a web survey of 300 physicians and 1,012 adults with type 2 diabetes uncontrolled on basal insulin (physician-confirmed HbA1c> 8% (64 mmol/mol)) from the UK (n=100 physicians and 620 patients), Sweden (n=100 physicians and 240 patients) and Switzerland (n=100 physicians and 152 patients).[1] Information was also collected from a control group of 295 adults with type 2 diabetes controlled on basal insulin (physician-confirmed HbA1c <7.5% (59 mmol/mol) from the UK.[1] In total, data were collected from 1,607 patients and physicians for analysis. The purpose of the study was to investigate how this patient population perceived control and whether it differed from perceptions of control among physicians.[1]
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
Further Information
Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com
Asa Josefsson
+45-3079-7708
aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com
Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com
Daniel Bohsen
+45-3079-6376
dabo@novonordisk.com
Frank Daniel Mersebach (US)
+1-609-235-8567
fdni@novonordisk.com
Reference
1. Brod M, et al. Perceptions of diabetes control among physicians and patients with uncontrolled type 2 diabetes using basal insulin. Poster presentation (#890) at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting, 16 September 2015.
Video: http://www.multivu.com/players/English/7625651-study-perceptions-type-2-diabetes/
Source: Novo Nordisk
PRNewswire
New Xultophy(R) (IDegLira) Phase 3b Trial Shows Improvements in Patient-Reported Outcomes Versus Insulin Glargine
This material is intended for global medical media only. For journalistic assessment and preparation before publication.
New findings from the DUAL(TM) V phase 3b clinical trial showed greater improvements in treatment-related satisfaction and patient-reported physical health in people treated with Xultophy(R) versus insulin glargine U100.[1] The DUAL(TM) V trial evaluated the efficacy and safety of Xultophy(R) (IDegLira), a once-daily single-injection combination of Tresiba(R) (insulin degludec) and Victoza(R) (liraglutide) compared to further intensification with insulin glargine U100 in adults with type 2 diabetes uncontrolled on insulin glargine U100.
The findings based on validated patient-reported outcomes (PRO) questionnaires completed by participants in the DUAL(TM) V trial were announced today at the 51st European Association for the Study of Diabetes (EASD) in Stockholm, Sweden.[1]
"The true impact of a treatment on a patient's life goes beyond efficacy and safety endpoints. The patient's perception of how a treatment influences their well-being and daily living is critical for understanding a therapy's value," said Professor Stephen Gough, University of Oxford and Oxford University Hospitals NHS Trust. "It is for this reason we're excited to see that patients' positive perception in the DUAL(TM) V trial was consistent with the clinical results."
PRO data provide patients' perspective on quality of life (QoL) and treatment satisfaction. This type of data is valuable because it reflects patients' thoughts, complaints and opinions that researchers couldn't otherwise measure or observe.[2] PRO from the DUAL(TM) V trial were assessed by two questionnaires, the Treatment Related Impact Measure for Diabetes (TRIM-D) and Short Form-36 Health Survey (SF-36). The collected data are scored in categories known as domains.
The TRIM-D generates a total score based on the assessment of five domains: treatment burden, daily life, diabetes management, compliance and psychological health. Patients treated with Xultophy(R) achieved a significantly greater improvement from baseline in TRIM-D total score than patients treated with insulin glargine U100 (p=0.003).[1] In particular, patients treated with Xultophy(R) experienced significantly greater improvement in the TRIM-D domains, treatment burden (p=0.017) and diabetes management (p<0.001) than patients treated with insulin glargine U100.[1]
SF-36 is a validated generic questionnaire that can be scored into eight domains and two overall component summary scales: the physical component summary (PCS) which is a measure of physical health, and the mental component summary (MCS), which is a measure of emotional health.[1] Patients treated with Xultophy(R) experienced a significantly greater improvement in the PCS (p<0.001) score than patients treated with insulin glargine U100, whilst there was no difference with regards to the MCS score between the two arms. [1]
In addition, findings from the DUAL(TM) V clinical trial demonstrated that people with type 2 diabetes treated with Xultophy(R) versus insulin glargine U100 achieved superior HbA1c reductions (1.8% vs 1.1%; p?0.001), body weight change (1.4 kg decrease vs 1.8 kg increase, a 3.2 kg difference; p?0.001) and a 57% lower rate of confirmed hypoglycaemia (2.2 vs 5.1 events per patient year exposure; p?0.001).[3][4]
About Xultophy(R)
Xultophy(R) is a once-daily single injection combination of Tresiba(R) (insulin degludec), a once-daily basal insulin analogue, and Victoza(R) (liraglutide), a once-daily human GLP-1 analogue.[5] The maximum dose of Xultophy(R) is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide). Xultophy(R) is being investigated in the DUAL(TM) clinical trial programme which includes two phase 3a and a number of phase 3b trials, encompassing more than 3,500 people with type 2 diabetes. Xultophy(R) was granted marketing authorisation by the European Commission on 18 September 2014 and approved in Switzerland on 12 September 2014.[5][6]
About DUAL(TM) V
DUAL(TM) V was a phase 3b, 26-week, treat-to-target, randomised, open-label, multicentre trial conducted in 10 countries with 557 patients. The trial was designed to show non-inferiority in HbA1c and to subsequently demonstrate superiority in HbA1c, body weight and rate of hypoglycaemia. The trial compared the efficacy and safety of Xultophy(R) versus insulin glargine, both added on to metformin, in adults with type 2 diabetes uncontrolled on insulin glargine (20-50 units). The pretrial mean dose of insulin glargine was 32 units. Patients could be titrated to the maximum dose of Xultophy(R) (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide) and there was no maximum daily dose of insulin glargine.[4]
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
Further information
Media:
Katrine Sperling +45-4442-6718 krsp@novonordisk.com
Asa Josefsson +45-3079-7708 aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen +45-3075-9085 phak@novonordisk.com
Melanie Raouzeos +45-3075-3479 mrz@novonordisk.com
Daniel Bohsen +45-3079-6376 dabo@novonordisk.com
Frank Daniel Mersebach (U.S.) +1-609-235-8567 fdni@novonordisk.com
References
1. Lingvay I, Perez Manghi FC, Garcia-Hernandez PA, et al. Insulin degludec/liraglutide (IDegLira) improves patient-reported outcomes in subjects with type 2 diabetes uncontrolled on insulin glargine + metformin: DUAL V Study. (#831) at 51st European Association for the Study of Diabetes (EASD), 16 September 2015. Stockholm, Sweden.
2. Fayers P, Machin D. Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes. 2007.
3. Buse J, Perez Manghi F, Garcia Hernandez P, et al. Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IG) in A1c reduction, risk of hypoglycemic and weight change: DUAL[TM] V study. Oral presentation (#166-OR) at the 75th Scientific Sessions of the American Diabetes Association (ADA), 7 June 2015.
4. Buse JB, Perez Manghu FC, Garcia-Hernandez PA, et al. Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IGlar) in HbA1c reduction, risk of hypoglycaemia and weight change: DUAL[TM] V Study. Presentation (#836) at the 51st European Association for the Study of Diabetes (EASD), 16 September 2015.
5. EMA. Xultophy(R) summary of product characteristics. Available at: http://ec.europa.eu/health/documents/community-register/2014/20140918129550/anx_129550_en.pdf Last accessed: 1 June 2015.
6. SwissMedic. Xultophy(R): information for professionals.
ZINC ID: HQMMA/XT/0815/0274
Source: Novo Nordisk
PRNewswire
New findings from the DUAL(TM) V phase 3b clinical trial showed greater improvements in treatment-related satisfaction and patient-reported physical health in people treated with Xultophy(R) versus insulin glargine U100.[1] The DUAL(TM) V trial evaluated the efficacy and safety of Xultophy(R) (IDegLira), a once-daily single-injection combination of Tresiba(R) (insulin degludec) and Victoza(R) (liraglutide) compared to further intensification with insulin glargine U100 in adults with type 2 diabetes uncontrolled on insulin glargine U100.
The findings based on validated patient-reported outcomes (PRO) questionnaires completed by participants in the DUAL(TM) V trial were announced today at the 51st European Association for the Study of Diabetes (EASD) in Stockholm, Sweden.[1]
"The true impact of a treatment on a patient's life goes beyond efficacy and safety endpoints. The patient's perception of how a treatment influences their well-being and daily living is critical for understanding a therapy's value," said Professor Stephen Gough, University of Oxford and Oxford University Hospitals NHS Trust. "It is for this reason we're excited to see that patients' positive perception in the DUAL(TM) V trial was consistent with the clinical results."
PRO data provide patients' perspective on quality of life (QoL) and treatment satisfaction. This type of data is valuable because it reflects patients' thoughts, complaints and opinions that researchers couldn't otherwise measure or observe.[2] PRO from the DUAL(TM) V trial were assessed by two questionnaires, the Treatment Related Impact Measure for Diabetes (TRIM-D) and Short Form-36 Health Survey (SF-36). The collected data are scored in categories known as domains.
The TRIM-D generates a total score based on the assessment of five domains: treatment burden, daily life, diabetes management, compliance and psychological health. Patients treated with Xultophy(R) achieved a significantly greater improvement from baseline in TRIM-D total score than patients treated with insulin glargine U100 (p=0.003).[1] In particular, patients treated with Xultophy(R) experienced significantly greater improvement in the TRIM-D domains, treatment burden (p=0.017) and diabetes management (p<0.001) than patients treated with insulin glargine U100.[1]
SF-36 is a validated generic questionnaire that can be scored into eight domains and two overall component summary scales: the physical component summary (PCS) which is a measure of physical health, and the mental component summary (MCS), which is a measure of emotional health.[1] Patients treated with Xultophy(R) experienced a significantly greater improvement in the PCS (p<0.001) score than patients treated with insulin glargine U100, whilst there was no difference with regards to the MCS score between the two arms. [1]
In addition, findings from the DUAL(TM) V clinical trial demonstrated that people with type 2 diabetes treated with Xultophy(R) versus insulin glargine U100 achieved superior HbA1c reductions (1.8% vs 1.1%; p?0.001), body weight change (1.4 kg decrease vs 1.8 kg increase, a 3.2 kg difference; p?0.001) and a 57% lower rate of confirmed hypoglycaemia (2.2 vs 5.1 events per patient year exposure; p?0.001).[3][4]
About Xultophy(R)
Xultophy(R) is a once-daily single injection combination of Tresiba(R) (insulin degludec), a once-daily basal insulin analogue, and Victoza(R) (liraglutide), a once-daily human GLP-1 analogue.[5] The maximum dose of Xultophy(R) is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide). Xultophy(R) is being investigated in the DUAL(TM) clinical trial programme which includes two phase 3a and a number of phase 3b trials, encompassing more than 3,500 people with type 2 diabetes. Xultophy(R) was granted marketing authorisation by the European Commission on 18 September 2014 and approved in Switzerland on 12 September 2014.[5][6]
About DUAL(TM) V
DUAL(TM) V was a phase 3b, 26-week, treat-to-target, randomised, open-label, multicentre trial conducted in 10 countries with 557 patients. The trial was designed to show non-inferiority in HbA1c and to subsequently demonstrate superiority in HbA1c, body weight and rate of hypoglycaemia. The trial compared the efficacy and safety of Xultophy(R) versus insulin glargine, both added on to metformin, in adults with type 2 diabetes uncontrolled on insulin glargine (20-50 units). The pretrial mean dose of insulin glargine was 32 units. Patients could be titrated to the maximum dose of Xultophy(R) (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide) and there was no maximum daily dose of insulin glargine.[4]
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
Further information
Media:
Katrine Sperling +45-4442-6718 krsp@novonordisk.com
Asa Josefsson +45-3079-7708 aajf@novonordisk.com
Investors:
Peter Hugreffe Ankersen +45-3075-9085 phak@novonordisk.com
Melanie Raouzeos +45-3075-3479 mrz@novonordisk.com
Daniel Bohsen +45-3079-6376 dabo@novonordisk.com
Frank Daniel Mersebach (U.S.) +1-609-235-8567 fdni@novonordisk.com
References
1. Lingvay I, Perez Manghi FC, Garcia-Hernandez PA, et al. Insulin degludec/liraglutide (IDegLira) improves patient-reported outcomes in subjects with type 2 diabetes uncontrolled on insulin glargine + metformin: DUAL V Study. (#831) at 51st European Association for the Study of Diabetes (EASD), 16 September 2015. Stockholm, Sweden.
2. Fayers P, Machin D. Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes. 2007.
3. Buse J, Perez Manghi F, Garcia Hernandez P, et al. Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IG) in A1c reduction, risk of hypoglycemic and weight change: DUAL[TM] V study. Oral presentation (#166-OR) at the 75th Scientific Sessions of the American Diabetes Association (ADA), 7 June 2015.
4. Buse JB, Perez Manghu FC, Garcia-Hernandez PA, et al. Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IGlar) in HbA1c reduction, risk of hypoglycaemia and weight change: DUAL[TM] V Study. Presentation (#836) at the 51st European Association for the Study of Diabetes (EASD), 16 September 2015.
5. EMA. Xultophy(R) summary of product characteristics. Available at: http://ec.europa.eu/health/documents/community-register/2014/20140918129550/anx_129550_en.pdf Last accessed: 1 June 2015.
6. SwissMedic. Xultophy(R): information for professionals.
ZINC ID: HQMMA/XT/0815/0274
Source: Novo Nordisk
PRNewswire
New Data Confirm Tresiba(R) U200 Delivers Significantly Lower Rates of Confirmed Hypoglycaemia Versus Insulin Glargine U100
This material is intended for global medical media only.
For journalistic assessment and preparation before publication.
New data presented today at the 51st annual meeting of the European Association for the Study of Diabetes (EASD) show that patients with type 2 diabetes receiving the U200 formulation of Tresiba(R) (insulin degludec) experienced significantly lower rates of confirmed hypoglycaemia and significantly reduced mean fasting blood glucose compared to those receiving insulin glargine U1001. Tresiba(R) U200 is twice as concentrated as U100, allowing patients to inject up to 160 units in a single injection, rather than in two separate injections.
"These findings provide valuable insights to physicians treating patients with type 2 diabetes, many of whom require higher doses of insulin," commented Dr Mark Warren, lead study investigator. "The more concentrated formulation of Tresiba(R) also means fewer injections, which will be a welcome option for those patients who require higher than 80 units."
The 32-week, open-label, crossover, treat-to-target trial compared the safety, efficacy and patient-reported outcomes of Tresiba(R) U200 to insulin glargine U100 in patients who might benefit from a low-volume basal insulin. In the study, patients with type 2 diabetes also reported higher satisfaction with Tresiba(R) U200, highlighting an overall preference versus insulin glargine U100. Patients receiving the more concentrated formulation of Tresiba(R) also reported numerically lower cases of nocturnal hypoglycaemia and lower weight change and rated the delivery device FlexTouch(R) significantly better for function1.
After 16 weeks, the study demonstrated1:
- Tresiba(R) U200 delivered non-inferiority to insulin glargine with respect to change in patient blood glucose levels
- Significantly reduced mean fasting plasma glucose with Tresiba(R) U200 versus insulin glargine (-0.82 mmol/L vs -0.05 mmol/L, p<0.05)
- Significantly lower confirmed hypoglycaemia rate with Tresiba(R) U200 versus insulin glargine (estimated rate ratio [ERR]; 0.59, p<0.05)
- Tresiba(R) U200 delivered numerically lower nocturnal hypoglycaemia rate versus insulin glargine (ERR; 0.66)
- Lower mean weight change with Tresiba(R) U200 versus insulin glargine (0.42 kg vs 1.04kg).
In addition, 32.1% of patients in the Tresiba(R) U200 arm and 35.2% in the insulin glargine arm reported adverse events. Of these, 2.9% and 2.8% respectively were serious adverse events requiring third party intervention.
About Tresiba(R)
Tresiba(R) (insulin degludec) is a once-daily basal insulin that provides duration of action beyond 42 hours2,3. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba(R) allows for flexibility in day-to-day dosing time when needed2,4,5. Tresiba(R) U200 enables up to 160 units of insulin to be dosed in a single injection, allowing people with diabetes to administer the same amount of insulin in half the volume as they are able to with current U100 formulations. No dose conversion is needed when transferring a patient from U100 to U200.
Tresiba(R) received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
References
1) Warren M, et al. Efficacy, patient reported outcomes and safety of insulin degludec U200 compared with insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Presented at the 51st annual meeting of the European Association for the Study of Diabetes (EASD); Stockholm, Sweden, 14-18 September 2015.
2) Tresiba(R) Summary of Product Characteristics. Bagsv?rd, Denmark, Novo Nordisk A/S; June 2015.
3) Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014;53:787-800.
4) Meneghini L, et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily. Diabetes Care. 2013;36:858-64.
5) Mathieu C, et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013;98:1154-62.
Source: Novo Nordisk
PRNewswire
For journalistic assessment and preparation before publication.
New data presented today at the 51st annual meeting of the European Association for the Study of Diabetes (EASD) show that patients with type 2 diabetes receiving the U200 formulation of Tresiba(R) (insulin degludec) experienced significantly lower rates of confirmed hypoglycaemia and significantly reduced mean fasting blood glucose compared to those receiving insulin glargine U1001. Tresiba(R) U200 is twice as concentrated as U100, allowing patients to inject up to 160 units in a single injection, rather than in two separate injections.
"These findings provide valuable insights to physicians treating patients with type 2 diabetes, many of whom require higher doses of insulin," commented Dr Mark Warren, lead study investigator. "The more concentrated formulation of Tresiba(R) also means fewer injections, which will be a welcome option for those patients who require higher than 80 units."
The 32-week, open-label, crossover, treat-to-target trial compared the safety, efficacy and patient-reported outcomes of Tresiba(R) U200 to insulin glargine U100 in patients who might benefit from a low-volume basal insulin. In the study, patients with type 2 diabetes also reported higher satisfaction with Tresiba(R) U200, highlighting an overall preference versus insulin glargine U100. Patients receiving the more concentrated formulation of Tresiba(R) also reported numerically lower cases of nocturnal hypoglycaemia and lower weight change and rated the delivery device FlexTouch(R) significantly better for function1.
After 16 weeks, the study demonstrated1:
- Tresiba(R) U200 delivered non-inferiority to insulin glargine with respect to change in patient blood glucose levels
- Significantly reduced mean fasting plasma glucose with Tresiba(R) U200 versus insulin glargine (-0.82 mmol/L vs -0.05 mmol/L, p<0.05)
- Significantly lower confirmed hypoglycaemia rate with Tresiba(R) U200 versus insulin glargine (estimated rate ratio [ERR]; 0.59, p<0.05)
- Tresiba(R) U200 delivered numerically lower nocturnal hypoglycaemia rate versus insulin glargine (ERR; 0.66)
- Lower mean weight change with Tresiba(R) U200 versus insulin glargine (0.42 kg vs 1.04kg).
In addition, 32.1% of patients in the Tresiba(R) U200 arm and 35.2% in the insulin glargine arm reported adverse events. Of these, 2.9% and 2.8% respectively were serious adverse events requiring third party intervention.
About Tresiba(R)
Tresiba(R) (insulin degludec) is a once-daily basal insulin that provides duration of action beyond 42 hours2,3. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba(R) allows for flexibility in day-to-day dosing time when needed2,4,5. Tresiba(R) U200 enables up to 160 units of insulin to be dosed in a single injection, allowing people with diabetes to administer the same amount of insulin in half the volume as they are able to with current U100 formulations. No dose conversion is needed when transferring a patient from U100 to U200.
Tresiba(R) received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com , Facebook , Twitter , LinkedIn , YouTube
References
1) Warren M, et al. Efficacy, patient reported outcomes and safety of insulin degludec U200 compared with insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Presented at the 51st annual meeting of the European Association for the Study of Diabetes (EASD); Stockholm, Sweden, 14-18 September 2015.
2) Tresiba(R) Summary of Product Characteristics. Bagsv?rd, Denmark, Novo Nordisk A/S; June 2015.
3) Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014;53:787-800.
4) Meneghini L, et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily. Diabetes Care. 2013;36:858-64.
5) Mathieu C, et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. J Clin Endocrinol Metab. 2013;98:1154-62.
Source: Novo Nordisk
PRNewswire
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