Semaglutide is a new glucagon-like-peptide-1 (GLP-1) analogue that can improve blood glucose levels of patients with type 2 diabetes who have a low risk of hypoglycemia. The drug is administered subcutaneously once a week.
These findings were the headline results from the fifth phase 3a clinical trial from the SUSTAIN 5 study. In this new trial, the efficacy and safety of 0.5mg and 1.0mg semaglutide was compared with placebo as add-on to basal insulin alone or basal insulin in combination with metformin. 397 people with type 2 diabetes received treatment for 30 weeks.
Patients treated with 0.5mg and 1.0mg semaglutide achieved mean HbA1c reductions of 1.4 per cent and 1.8 per cent respective. The average baseline HbA1c of these participants was 65.0 mmol/mol (8.4 per cent). In comparison, participants who took placebo only achieved a 0.1 per cent improvement.
Additionally, semaglutide patients experienced a statistically significant weight loss of 3.7kg (from the 0.5mg dose) and 6.4kg (on the 1.0mg dose) compared to weight loss of 1.4kg among patients treated with placebo. People taking insulin were also able to reduce their insulin doses by 10 and 15 per cent, respectively, compared to 3.0 per cent for the placebo group.
The discontinuation rate due to adverse effects was 5.0 and 6.0 per cent for patients taking 0.5mg and 1.0mg semaglutide, which compared to 1.0 per cent in the placebo group.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “We are excited about the results of SUSTAIN 5, showing superior efficacy in glycemic control and weight loss with semaglutide administered once-weekly in patients inadequately controlled on basal insulin.
“The results from the first five SUSTAIN trials support the potential for broad usage of semaglutide in people with type 2 diabetes, as results have been consistent when exploring people with both early onset as well as late stage type 2 diabetes.”
The final SUSTAIN trial, SUSTAIN6, is a two-year trial evaluating cardiovascular and other long-term health outcomes with semaglutide among 3,297 people with type 2 diabetes. Novo Nordisk expects to announce results of the trial in the first half of 2016.