Novo Nordisk 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.
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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.
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.
In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea which diminished over time. Nausea was reported by 22% of people treated with 1.0 mg semaglutide once-weekly compared with 11% of people treated with 2.0 mg exenatide once-weekly. The discontinuation rate due to all adverse events for 1.0 mg semaglutide was 9.4% compared to 7.2% for 2.0 mg exenatide.
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"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."
Novo Nordisk expects to announce headline results of the four remaining SUSTAIN trials within the next coming quarters.
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