Positive results have been reported from the sixth and last global phase 3a study (SUSTAIN 6) of semaglutide (Novo Nordisk), an investigational glucagon-like peptide-1 (GLP-1) analogue, which was administered subcutaneously once weekly in the SUSTAIN trials. The new double-blind study investigated the long-term cardiovascular and other safety outcomes of semaglutide (0.5 mg and 1.0 mg) compared with placebo, both administered in addition to standard of care. Approximately 3,300 subjects with type-2 diabetes (T2D) were treated for two years.
The SUSTAIN 6 trial achieved its primary endpoint of demonstrating the noninferiority of semaglutide compared with placebo in terms of major cardiovascular events (MACEs), as well as a statistically significant reduction in cardiovascular risk. The primary endpoint was defined as the composite outcome of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
According to Novo Nordisk, semaglutide can help patients with T2D achieve substantial improvement of blood glucose with a low risk of hypoglycemia. In addition, semaglutide induces weight loss by decreasing appetite and food intake. Semaglutide administered subcutaneously once weekly is in phase 3 development for the treatment of patients with T2D. The drug is also being developed as an oral tablet for the treatment of T2D and as once-daily subcutaneous formulations for the treatment of T2D and weight management.
Novo Nordisk expects to file once-weekly subcutaneous semaglutide for FDA review as a T2D treatment in the fourth quarter of 2016.
The phase 3 SUSTAIN clinical trial program consisted of six global studies of semaglutide administered subcutaneously once weekly in more than 7,000 subjects with T2D.
Source: Novo Nordisk; April 28, 2016.