LISBON, Portugal, September 12, 2017 /PRNewswire/
A post-hoc analysis of the SUSTAIN 1-5 trials demonstrated that a greater proportion of adults with type 2 diabetes achieved a clinically meaningful reduction in both HbA1c and body weight with once-weekly semaglutide vs. comparator treatments. Comparators included placebo, sitagliptin, insulin glargine U100 or exenatide extended release (ER). The analysis was presented today at the 53rd Annual Meeting of the European Association For The Study Of Diabetes.
"As a physician, helping patients with type 2 diabetes achieve glycaemic and weight loss targets can be challenging," said Dr Helena Rodbard, SUSTAIN 5 investigator and medical director at Endocrine and Metabolic Consultants, Rockville, Maryland. "The meaningful reductions demonstrated with semaglutide in both glucose and body weight are encouraging, as more treatment strategies are needed to help meet this challenge."
Significantly more people treated with once-weekly semaglutide achieved the clinically meaningful composite endpoint of ≥1% HbA1c reduction and ≥5% weight loss with 0.5 mg (25-35%) and 1.0 mg (38-56%) semaglutide vs. all comparators (2-13%; p<0.0001) in SUSTAIN 1-5.
In addition, more people achieved the composite endpoint with once-weekly semaglutide 1.0 mg compared with semaglutide 0.5 mg (p<0.0001 for SUSTAIN 2, 4 and 5; p=0.17 for SUSTAIN 1).
In this post-hoc analysis, semaglutide was well tolerated, with a safety profile similar to that of other glucagon-like peptide-1 receptor agonists. The most common adverse event with semaglutide was nausea. In SUSTAIN 1-4, severe or blood glucose confirmed symptomatic hypoglycaemia events were fewer or similar with once-weekly semaglutide vs. comparators. In SUSTAIN 5, on a background of basal insulin, more events were observed with once-weekly semaglutide than with placebo.
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.-Once-weekly semaglutide is currently under review by seven regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
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 41,400 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
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1. Rodbard H, Bellary S, Hramiak I, et al. Responder analysis of subjects achieving HbA1c ≥1% and weight loss ≥5% across SUSTAIN 1-5 clinical trials. Poster 802. 53rd Annual Meeting of the European Association For The Study Of Diabetes (EASD), Lisbon, Portugal; 11-15 September 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. 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD), Munich, Germany; 12-16 September 2016.
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5. Saad H, Hjersted J, Axelsen MB, et al. Semaglutide improves postprandial glucose and lipid metabolism and delays first-hour gastric emptying in subjects with obesity. Canadian Journal of Diabetes. 2016; 40:S34-S35.
Peter Hugreffe Ankersen
Kasper Veje (US)