• Danish drugmaker Novo Nordisk said Tuesday its PIONEER 2 study testing oral semaglutide in patients with type 2 diabetes met its primary objective, showing a statistically significant and superior improvement in HbA1c at 26 weeks compared to Boehringer Ingelheim and Eli Lilly’s rival Jardiance.
• Novo analyzed the trial data under two statistical methods. Per a secondary statistical approach, patients treated with semaglutide achieved a HbA1c level of 1.4% at 26 weeks and 1.3% at 52 weeks — higher than the 0.9% and 0.8% achieved at the same time points by those given Jardiance.
• The difference in weight loss between the two treatments, however, was not statistically significant under the primary statistical approach, which assesses the drug’s effect regardless of discontinuation or use of rescue medication.

Earlier this year, Novo Nordisk’s oral semaglutide hit the primary endpoint in its first Phase 3 trial, called PIONEER 1. In this, the first of ten PIONEER Phase 3a studies, patients taking oral semaglutide saw improvements in both HbA1c and weight loss versus placebo.
The headline results from this PIONEER 2 Phase 3a study, despite the mixed results on weight loss, should further support development of the agent for treatment of type 2 diabetes.
Using the secondary approach, Novo found that 72% of patients treated with semaglutide reached the American Diabetes Association (ADA) treatment target of HbA1c below 7.0%, compared to the 47% of patients treated with Jardiance (empagliflozin).
The ten PIONEER studies, which include 8,845 people with type 2 diabetes, are all expected to complete during 2018.
Novo’s once-weekly subcutaneous semaglutide, branded as Ozempic, first hit the U.S. market in December 2017 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, with an additional approval in February 2018 as a monotherapy for metformin-intolerant patients.
The Danish drugmaker has also turned its focus towards obesity as rising competition and pricing pressures have weighed on the diabetes market in the U.S. Toward that end, semaglutide is currently being tested in a 4,500-patient Phase 3 study in obesity, and the company is running a study in 12,500 people looking at cardiovascular outcomes in obese patients using semaglutide.
Despite its size and unmet need, however, the obesity market also presents numerous challenges that have tripped up previously approved prescription weight loss drugs.