Novo Nordisk has announced headline data from the PIONEER 2 trial showing that oral semaglutide was better at improving HbA1c levels in patients with type II diabetes than Lilly’s and Boehringer Ingelheim's Jardiance.
Oral semaglutide, a once-daily, oral GLP-1 analogue while Jardiance (empagliflozin) is an SGLT-2 inhibitor.
The PIONEER 2 trial employed two distinct statistical approaches to evaluating the effects of oral semaglutide; a primary statistical approach, required by recent regulatory guidance evaluating the effect regardless of discontinuation of treatment and use of rescue medication, and a secondary statistical approach, describing the effect while on treatment and without use of rescue medication.
The trial achieved its primary goal of showing a statistically significant and superior improvement in HbA1c at 26 weeks in patients receiving oral semaglutide compared to those given Jardiance using the primary approach, but difference in weight loss between the two treatment groups was not statistically significant.
When applying the secondary statistical approach, people treated with oral semaglutide achieved a significant improvement in HbA1c of 1.4 percent at 26 weeks and 1.3 percent at 52 weeks, compared with 0.9 percent and 0.8 percent with Jardiance, respectively.
Patients taking oral semaglutide showed weight loss of 4.2kg at 26 weeks and 4.7kg at 52 weeks, versus 3.8 kg with Jardiance at both 26 weeks and 52 weeks, with the difference reaching statistical significant at 52 weeks.
Novo also said oral semaglutide was “well-tolerated and with a profile consistent with GLP-1-based therapy”, the most common adverse event being mild to moderate nausea, which diminished over time.
In PIONEER 2, 20 percent of people taking oral semaglutide experienced nausea during the trial, while the proportion discontinuing treatment due to adverse events was 11 percent versus 4 percent in the Jardiance arm.
“We are very excited about these results, which demonstrate that people treated with 14mg oral semaglutide for one year achieved statistically significant reductions in blood glucose and body weight compared to people treated with 25mg empagliflozin,” said Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer.
“PIONEER 2 is an important milestone in the clinical development of oral semaglutide and we look forward to further understanding the clinical profile of oral semaglutide in the remaining PIONEER trials.”