Headline results of the PIONEER 2 trial, a 52-week, randomized, open-label, active-controlled, parallel-group, multicenter, multinational, phase 3a trial, were announced. In the PIONEER 2 trial, the efficacy and safety of 14 mg semaglutide was compared with 25 mg empagliflozin in 816 type 2 diabetes (T2DM) patients, insufficiently controlled by metformin. The primary endpoints were change in HbA1c and body weight at 26 weeks. Secondary endpoints included change in HbA1c and body weight at 52 weeks.

Patients with semaglutide achieved a statistically significant improvement in HbA1c of 1.4% at 26 weeks and 1.3% at 52 weeks compared to 0.9% and 0.8%, respectively, with empagliflozin. Weight loss was 4.2 kg at 26 weeks and 4.7 kg at 52 weeks with semaglutide versus 3.8 kg with empagliflozin at both 26 weeks and 52 weeks. Increased weight loss with semaglutide was statistically significant compared to empagliflozin at the 52-week time point.

Semaglutide was well-tolerated. The most common adverse event with semaglutide treatment was nausea (20% of patients). Drug discontinuation due to adverse event was 11% for semaglutide and 4% for empagliflozin.

PIONEER 2 is part of the PIONEER program, evaluating semaglutide in 8845 T2DM in 10 clinical trials and expected to complete in 2018.

Source: press release Novo Nordisk, May 29, 2018