Semaglutide is a once-weekly investigational analogue of human glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon secretion in a glucosedependent manner, while decreasing appetite and food intake.
Novo Nordisk announced that semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, significantly improved glycaemic control compared to placebo, as add-on to basal insulin alone or in combination with metformin, in adults with a mean type 2 diabetes duration of 13 years. Results from SUSTAIN 5 were presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.
The 30-week trial showed that, from a mean baseline HbA1c of 8.4%, adults treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significant and superior HbA1c reductions of 1.4% and 1.8%, respectively, vs 0.1% reduction with placebo. In addition, more adults treated with 0.5 mg and 1.0 mg semaglutide achieved HbA1c targets compared with placebo: HbA1c <7% (61% and 79% vs 11%) and ≤6.5% (41% and 61% vs 5%).1 Adults with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved superior weight loss vs placebo (3.7 kg and 6.4 kg vs 1.4 kg) from a mean baseline body weight of 91.7 kg.
“In the SUSTAIN 5 trial, we have seen that adding once-weekly semaglutide to basal insulin alone or in combination with metformin can help people with long-standing type 2 diabetes achieve glycaemic control and weight loss,” said Dr Helena Rodbard, SUSTAIN 5 investigator and Medical Director at Endocrine and Metabolic Consultants, Rockville, Maryland. “As a treating physician, I am encouraged by these findings as many people with long-standing type 2 diabetes experience suboptimal glucose control and weight gain.”
Adults treated with both doses of semaglutide demonstrated significantly greater reductions in fasting plasma glucose (FPG) vs placebo (1.6 mmol/L and 2.4 mmol/L vs 0.5 mmol/L), from a mean FPG baseline of 8.6 mmol/L. Furthermore, both semaglutide doses resulted in significant postprandial glucose reduction, measured as the postprandial increment of 7-point self-measured plasma glucose compared to placebo.
Adverse events were reported for 68.9% and 64.1% of adults treated with 0.5 mg and 1.0 mg semaglutide, respectively, and for 57.9% of adults treated with placebo. The rates of serious adverse events observed for adults treated with 0.5 mg and 1.0 mg semaglutide compared with placebo were 6.1% and 9.2% vs 6.8%. The proportion of adults treated with 0.5 mg and 1.0 mg semaglutide discontinuing due to adverse events were 4.5% and 6.1% vs 0.8% with placebo; the majority of discontinuations with semaglutide were due to gastrointestinal adverse events.