Patients with type 2 diabetes who received semaglutide had statistically significant reductions in cardiovascular risk compared with patients who received placebo, according to a phase 3a trial.
The groups had similar rates of major cardiovascular events, which the researchers defined as the composite of the first occurrence of cardiovascular death, nonfatal MI or nonfatal stroke.
Novo Nordisk, which announced the top-line results in a news release, said that the company expects to file for an FDA approval in the fourth quarter of 2016.
Semaglutide is a glucagon-like peptide-1 analogue administered subcutaneously once weekly in patients with type 2 diabetes. Novo Nordisk is also evaluating semaglutide in an oral tablet and a once-daily subcutaneous injection to treat type 2 diabetes.
This double-blinded trial, known as SUSTAIN 6, enrolled 3,300 people with type 2 diabetes who were treated for 104 weeks with semaglutide or placebo. During the study, there were 250 major adverse cardiovascular events, although Novo Nordisk did not disclose how many events occurred in each group.
The company also mentioned that the safety of semaglutide was consistent with five previous trials that examined the drug.
In September, the FDA approved two drugs from Novo Nordisk to treat type 2 diabetes: insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg 70/30). Both drugs are injectable, long-acting insulins.