Novo Nordisk announced on Friday the first Phase III success for its once-weekly GLP-1 analogue semaglutide.
Semaglutide is Novo’s new glucagon-like peptide-1 (GLP-1) analogue targetted at helping people with type 2 diabetes see improvement in blood glucose with low risk of hypoglycaemia. The compound worked well in this late-stage clinical trial, and gives hopes for agency approval on this medicine, which some analysts say as key for the firm maintaining it’s the diabetes field.
The trial was assessing efficacy and safety of 0.5 mg and 1.0 mg doses over 30 weeks of treatment, in comparison to placebo. 388 patients with type 2 diabetes previously on diet and exercise were involved.
The trial’s primary objective was achieved, showing that from a mean baseline HbA1c reading of 8.1%, people treated with doses of 0.5 mg and 1.0 mg semaglutide had superior improvements in HbA1c of 1.5% and 1.6%, compared to no change in HbA1c in the placebo group.
HbA1c is a measure commonly used to determine average blood sugar concentration. 74% and 73% of the people treated with 0.5 mg and 1.0 mg semaglutide reached the American Diabetes Association and the European Association for the Study of Diabetes treatment target of HbA1c below 7%.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, says:
“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. We look forward to further results from the SUSTAIN clinical development programme.”
Semaglutide also can result in weight loss by decreasing appetite and food intake. Semaglutide administered once-weekly is currently in development for the treatment of type 2 diabetes.