Novo Nordisk on Wednesday said that it has completed headline results of the phase 3a trials PIONEER 4 comparing oral semaglutide as a treatment for adults with type 2 diabetes to Victoza and placebo, as well as PIONEER 7 which had a goal to compare oral semaglutide once daily tablet, as a treatment for adults with type 2 diabetes to sitagliptin 100 mg.
Novo Nordisk said that wwo distinct statistical approaches to evaluate the effects of oral semaglutide – a new GLP-1 analogue taken once daily as a tablet – were applied in the PIONEER 4 and 7 trials. One was a primary statistical approach required by recent regulatory guidance, evaluating the effect regardless of discontinuation of treatment and use of rescue medication. A secondary statistical approach was describing the effect while on treatment and without use of rescue medication.
In both trials, oral semaglutide was well-tolerated and with a profile consistent with GLP-1-based therapy.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk said that with the significant one-year results in a real-world dose setting, oral semaglutide was superior to sitagliptin by documenting a greater proportion of people achieving the ADA target. He also said that, at the same time, it was shown that oral semaglutide is even more efficacious in lowering glucose and body weight than the most widely used injectable GLP-1 treatment, Victoza.