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Novo Nordisk completes second Phase 3a trial with semaglutide
25 September 2015 • Author: Victoria White
Novo Nordisk has announced the headline results from the second Phase 3a trial for semaglutide, SUSTAIN3.
Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The trial investigated the efficacy and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide once-weekly after 56 weeks of treatment added on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes.
The trial achieved its objective by demonstrating that from a mean baseline HbA1c of 8.4%, people treated with 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.5% compared to the improvement in HbA1c of 0.9% with 2.0 mg exenatide once-weekly.
66% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below 7% compared with 40% of the people treated with 2.0 mg exenatide once-weekly.
Semaglutide provided greater glycaemic control and weight loss than exenatide
Furthermore, from a mean baseline body weight of 96 kg, people treated with 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 5.6 kg compared with a weight loss of 1.8 kg for people treated with 2.0 mg exenatide once-weekly.
“We are excited about these trial results, which show that 1.0 mg semaglutide injected once weekly provided better glycaemic control and greater weight loss than 2.0 mg exenatide once-weekly,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “These results support that semaglutide has the potential to become the most efficacious GLP-1 product for people with type 2 diabetes. We look forward to further results from the SUSTAIN clinical development programme.”
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