The results from SUSTAIN-1, the first phase 3a trial for Semaglutide, a new GLP-1 analogue administered once-weekly were presented.
The trial investigated the efficacy and safety of 0.5 mg and 1.0 mg Semaglutide as monotherapy during 30 weeks of treatment compared with placebo in 388 people with type 2 diabetes previously on diet and exercise.
The trial achieved its primary objective by demonstrating that from a mean baseline HbA1c of 8.1%, people treated with doses of 0.5 mg and 1.0 mg Semaglutide, achieved superior improvements in HbA1c of 1.5% and 1.6%, respectively, compared to no change in HbA1c in the placebo group.
74% and 73% of the people treated with 0.5 mg and 1.0 mg Semaglutide, respectively, achieved the American Diabetes Association ( ADA ) and the European Association for the Study of Diabetes ( EASD ) treatment target of HbA1c below 7% compared with 25% of the people treated with placebo.
Furthermore, from a mean baseline of 92 kg, people treated with Semaglutide in both doses of 0.5 mg and 1.0 mg experienced a superior weight loss of 3.8 kg and 4.6 kg, respectively, compared with a weight loss of 1.0 kg for people treated with placebo.
In the trial, Semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were related to the gastrointestinal system, primarily nausea, were comparable to Liraglutide ( Victoza ) in similar trials and diminished over time.
The discontinuation rates due to all adverse events for 0.5 mg and 1.0 mg Semaglutide were 6% and 5% compared to a discontinuation rate of 2% for placebo.
Semaglutide is a new glucagon-like peptide-1 analogue that can help people with type 2 diabetes achieve substantial improvement of blood glucose with a low risk of hypoglycaemia.
In addition, Semaglutide induces weight loss by decreasing appetite and food intake.
Semaglutide administered once-weekly is in development for the treatment of type 2 diabetes. ( Xagena )
Source: Novo Nordisk, 2015