ORLANDO, Florida, April 2, 2017 /PRNewswire/ --
Abstract #620
Findings from a post hoc analysis of the phase 3a SUSTAIN 2-4 trials demonstrated greater mean reductions in HbA1c and body weight with once-weekly semaglutide treatment compared to sitagliptin, exenatide extended release (ER) and insulin glargine U100 in adults with type 2 diabetes, across multiple background oral antidiabetic (OAD) treatment categories. The results were presented today at the Endocrine Society's 99th Annual Meeting and Expo (ENDO 2017) in Orlando, FL, US.[1]
"Type 2 diabetes is a complex disease, and as a result many patients are not reaching their targets on current oral antidiabetic therapy," said Vanita Aroda, SUSTAIN 4 investigator and physician investigator at the MedStar Health Research Institute, Hyattsville, MD, US. "Results from this post hoc analysis show that once-weekly semaglutide consistently lowered blood glucose and weight in people with type 2 diabetes regardless of their current oral antidiabetic therapy."
On a background of metformin or metformin plus sulfonylurea, treatment with semaglutide (0.5 mg/1.0 mg) significantly reduced HbA1c compared with all treatment comparators (p<0.05). In the smaller groups of people on a background of less commonly used OADs (thiazolidinedione [TZD] alone, or TZD in combination with metformin or sulfonylurea), semaglutide 1.0 mg significantly reduced HbA1c vs. sitagliptin (p<0.05); there was a numerically greater reduction in HbA1c with semaglutide 0.5 mg vs. sitagliptin (p=non-significant [ns]); and semaglutide 1.0 mg demonstrated a greater reduction in HbA1c vs. exenatide ER, although statistical significance was not reached.[1]
Furthermore, people treated with semaglutide 1.0 mg achieved significantly greater reductions in mean body weight across all OAD categories vs. all comparators (p<0.05). People treated with semaglutide 0.5 mg on a background of metformin or metformin plus sulfonylurea achieved significantly greater reductions in mean body weight vs. sitagliptin, exenatide ER and insulin glargine U100 (p<0.0001). The reductions seen across the background treatment category of OADs less commonly used in this post hoc analysis did not reach statistical significance.[1]
The rate of severe or blood glucose-confirmed symptomatic hypoglycaemia for people treated with semaglutide (0.5 mg/1.0 mg) was comparable with sitagliptin and exenatide ER and lower compared with insulin glargine U100, irrespective of background OAD treatment.[1]
Semaglutide was well tolerated, with a similar safety profile to that of other GLP-1 receptor agonists.[1]
About semaglutide Semaglutide is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, while decreasing appetite and food intake.[2]-[5]
Once-weekly semaglutide is currently under review by the US Food and Drug Administration, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. If approved, the indication of once-weekly semaglutide will reflect the trial results and assessment by the regulatory authorities.
About the SUSTAIN clinical trial programme SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) is a clinical trial programme for semaglutide, administered once weekly, that comprises seven phase 3a global clinical trials and a cardiovascular outcomes trial, involving more than 8,000 adults with type 2 diabetes.
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 42,000 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information Media: Katrine Sperling +45-4442-6718 [email protected] Åsa Josefsson +45-3079-7708 [email protected] Investors : Peter Hugreffe Ankersen +45-3075-9085 [email protected] Hanna Ögren +45-3079-8519 [email protected] Anders Mikkelsen +45-3079-4461 [email protected] Kasper Veje (US) +1-609-235-8567 [email protected]
References
1. Aroda V, Pablo Frias J, Tabak Ö, et al. Semaglutide reduces HbA1c and body weight across multiple background OAD treatment categories. Abstract 620. 99th Annual Meeting of the Endocrine Society (ENDO), Orlando, USA; 1-4 April 2017.
2. Korsatko A, Brunner M, Sach-Friedl S, et al. Effect of once-weekly semaglutide on the counter-regulatory response to hypoglycaemia in subjects with type 2 diabetes. Abstract 764. European Association for the Study of Diabetes, 52nd Annual Meeting (EASD), Munich, Germany; 12-16 September 2016.
3. Blundell J, Finlayson G, Bhuhl Axelsen M, et al. Semaglutide reduces appetite and energy intake, improves control of eating and provides weight loss in subjects with obesity. American Diabetes Association, 76th Annual Meeting (ADA), New Orleans, USA; 10-14 June 2016.
4. Hjerpsted J, Buhl Axelsen M, Brooks A, et al. Semaglutide Improves Postprandial Glucose and Lipid Metabolism and Delays First-Hour Gastric Emptying in Subjects with Obesity. Abstract 1046. American Diabetes Association, 76th Annual Meeting (ADA), New Orleans, USA; 10-14 June 2016.
5. Kapitza C, Dahl K, Jaconsen B, et al. The effects of once-weekly semaglutide on ß-cell function in subjects with type 2 diabetes. Abstract 754. European Association for the Study of Diabetes, 52nd Annual Meeting (EASD), Munich, Germany; 12-16 September 2016.
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Abstract #620
Findings from a post hoc analysis of the phase 3a SUSTAIN 2-4 trials demonstrated greater mean reductions in HbA1c and body weight with once-weekly semaglutide treatment compared to sitagliptin, exenatide extended release (ER) and insulin glargine U100 in adults with type 2 diabetes, across multiple background oral antidiabetic (OAD) treatment categories. The results were presented today at the Endocrine Society's 99th Annual Meeting and Expo (ENDO 2017) in Orlando, FL, US.[1]
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"Type 2 diabetes is a complex disease, and as a result many patients are not reaching their targets on current oral antidiabetic therapy," said Vanita Aroda, SUSTAIN 4 investigator and physician investigator at the MedStar Health Research Institute, Hyattsville, MD, US. "Results from this post hoc analysis show that once-weekly semaglutide consistently lowered blood glucose and weight in people with type 2 diabetes regardless of their current oral antidiabetic therapy."
On a background of metformin or metformin plus sulfonylurea, treatment with semaglutide (0.5 mg/1.0 mg) significantly reduced HbA1c compared with all treatment comparators (p<0.05). In the smaller groups of people on a background of less commonly used OADs (thiazolidinedione [TZD] alone, or TZD in combination with metformin or sulfonylurea), semaglutide 1.0 mg significantly reduced HbA1c vs. sitagliptin (p<0.05); there was a numerically greater reduction in HbA1c with semaglutide 0.5 mg vs. sitagliptin (p=non-significant [ns]); and semaglutide 1.0 mg demonstrated a greater reduction in HbA1c vs. exenatide ER, although statistical significance was not reached.[1]
Furthermore, people treated with semaglutide 1.0 mg achieved significantly greater reductions in mean body weight across all OAD categories vs. all comparators (p<0.05). People treated with semaglutide 0.5 mg on a background of metformin or metformin plus sulfonylurea achieved significantly greater reductions in mean body weight vs. sitagliptin, exenatide ER and insulin glargine U100 (p<0.0001). The reductions seen across the background treatment category of OADs less commonly used in this post hoc analysis did not reach statistical significance.[1]
The rate of severe or blood glucose-confirmed symptomatic hypoglycaemia for people treated with semaglutide (0.5 mg/1.0 mg) was comparable with sitagliptin and exenatide ER and lower compared with insulin glargine U100, irrespective of background OAD treatment.[1]
Semaglutide was well tolerated, with a similar safety profile to that of other GLP-1 receptor agonists.[1]
About semaglutide Semaglutide is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, while decreasing appetite and food intake.[2]-[5]
Once-weekly semaglutide is currently under review by the US Food and Drug Administration, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. If approved, the indication of once-weekly semaglutide will reflect the trial results and assessment by the regulatory authorities.
About the SUSTAIN clinical trial programme SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) is a clinical trial programme for semaglutide, administered once weekly, that comprises seven phase 3a global clinical trials and a cardiovascular outcomes trial, involving more than 8,000 adults with type 2 diabetes.
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 42,000 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information Media: Katrine Sperling +45-4442-6718 [email protected] Åsa Josefsson +45-3079-7708 [email protected] Investors : Peter Hugreffe Ankersen +45-3075-9085 [email protected] Hanna Ögren +45-3079-8519 [email protected] Anders Mikkelsen +45-3079-4461 [email protected] Kasper Veje (US) +1-609-235-8567 [email protected]
References
1. Aroda V, Pablo Frias J, Tabak Ö, et al. Semaglutide reduces HbA1c and body weight across multiple background OAD treatment categories. Abstract 620. 99th Annual Meeting of the Endocrine Society (ENDO), Orlando, USA; 1-4 April 2017.
2. Korsatko A, Brunner M, Sach-Friedl S, et al. Effect of once-weekly semaglutide on the counter-regulatory response to hypoglycaemia in subjects with type 2 diabetes. Abstract 764. European Association for the Study of Diabetes, 52nd Annual Meeting (EASD), Munich, Germany; 12-16 September 2016.
3. Blundell J, Finlayson G, Bhuhl Axelsen M, et al. Semaglutide reduces appetite and energy intake, improves control of eating and provides weight loss in subjects with obesity. American Diabetes Association, 76th Annual Meeting (ADA), New Orleans, USA; 10-14 June 2016.
4. Hjerpsted J, Buhl Axelsen M, Brooks A, et al. Semaglutide Improves Postprandial Glucose and Lipid Metabolism and Delays First-Hour Gastric Emptying in Subjects with Obesity. Abstract 1046. American Diabetes Association, 76th Annual Meeting (ADA), New Orleans, USA; 10-14 June 2016.
5. Kapitza C, Dahl K, Jaconsen B, et al. The effects of once-weekly semaglutide on ß-cell function in subjects with type 2 diabetes. Abstract 754. European Association for the Study of Diabetes, 52nd Annual Meeting (EASD), Munich, Germany; 12-16 September 2016.
