Bagsværd, Denmark, 10 July 2015 - Novo Nordisk today announced the headline results from SUSTAIN1, the first phase 3a trial for semaglutide, a new GLP-1 analogue administered once-weekly. 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 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.
"We are excited about these results, which confirm that semaglutide has the potential to help people with type 2 diabetes achieve both good glycaemic control and a significant weight loss with one weekly injection," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We look forward to further results from the SUSTAIN clinical development programme."
Novo Nordisk expects to announce headline results of the five remaining SUSTAIN trials within the next nine months.
Semaglutide is a new glucagon-like peptide-1 (GLP-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.
About the SUSTAIN clinical programme
The SUSTAIN programme is a phase 3 clinical programme comprising six global trials of semaglutide administered once-weekly encompassing more than 7,000 people with type 2 diabetes.
SUSTAIN 1 - a 30-week efficacy and safety trial of semaglutide versus placebo in 388 drug-naïve people with type 2 diabetes.
SUSTAIN 2 - a 56-week efficacy and safety trial of semaglutide versus sitagliptin once-daily as add-on to metformin and/or TZD in 1,231 people with type 2 diabetes.
SUSTAIN 3 - a 56-week efficacy and safety trial of semaglutide versus exenatide ER 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs in 811 people with type 2 diabetes.
SUSTAIN 4 - a 30-week efficacy and safety trial of semaglutide versus insulin glargine once-daily as add-on to metformin with or without sulphonylurea in 1,089 insulin-naïve people with type 2 diabetes.
SUSTAIN 5 - a 30-week efficacy and safety trial of semaglutide versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in 397 people with type 2 diabetes.
SUSTAIN 6 - a 2-year trial to evaluate cardiovascular and other long-term outcomes with semaglutide in 3,297 people with type 2 diabetes.