Todd Hobbs, MD, CMO of Novo Nordisk, discusses the findings of the PIONEER 2 study.
Use of oral semaglutide resulted in reductions in HbA1c and body weight compared to empagliflozin in patients with uncontrolled type 2 diabetes at both the week 26 and week 52 endpoints in a recent trial.
Investigators presented the results of Pioneer 2 trial, which examined oral semaglutide versus empagliflozin added onto metformin monotherapy, at the American Diabetes Association (ADA) 2019 Scientific Sessions in San Francisco, CA.
PIONEER 2 was a 52-week randomized, open-label trial that compared GLP-1 oral semaglutide in a 14mg dose daily to empagliflozin 25mg in patients with uncontrolled Type 2 Diabetes. The trial involved a total of 821 patients (411 to oral semaglutide, 410 to empagliflozin).
Investigators found that oral semaglutide was superior to empagliflozin at reducing HbA1c at week 26, but was not superior in reducing weight at this point. At week 52, HbA1c reductions continued and were considered significantly greater compared to empagliflozin. Additionally, investigators noted that differences in weight loss between the 2 groups at week 52 showed that use of oral semaglutide resulted in greater reductions — unlike what was found at week 26.
Proportions of adverse events were similar between both groups. The most frequent adverse events were mild to moderate gastrointestinal events.
Novo Nordisk submitted a new drug application (NDA) to the US Food and Drug Administration for oral semaglutide in March. In an interview with MD Magazine® at ADA 2019, Todd Hobbs, MD, chief medical officer of Novo Nordisk North America, said the company is hopeful to learn whether their new treatment is approved by the FDA.
MD Mag: What were the results of the PIONEER 2 study?
Hobbs: So pioneer 2 which is versus empagliflozin, or Jardiance, was one of our trials presented here at the ADA just today. It's part of the PIONEER program and we were looking at comparators versus, really, all the relevant oral and even injectable therapies out there in type 2 diabetes patients. So, PIONEER 2 we went against the leading SGLT2 inhibitors and, fortunately as you saw, the results did show a significant a1c reduction at 26 weeks versus Jardiance — as well as significant weight benefits that were not statistically significant but were very relevant for that patient population and in that amount of weight loss. So, we're very encouraged by these results and they were received very well here today in San Francisco.
MD Mag: Why do you think the differences in reductions were greater at week 52 compared to week 26?
Hobbs: I think a lot of it had to do with with the study design of the trial going out to 52 weeks and certainly have dropouts in each arm and if you look at the primary s demand it actually takes in consideration rescue therapy so if those individuals drop out of the glp-1 arm they're probably going to get a rescue therapy that doesn't help their weight and vice-versa in the sglt2 arm if they drop out they could actually go on a glp-1 so there could be some of that at play and really the weight reductions in both arms were very nice and and a positive message that that you know three to four kilograms of weight reduction I think that the long-term the 52-week result kind of speaks to the durability of oral some aglet ID that that patients actually did stay on this therapy they did adhere to the dosing of this in the morning time and continue to see the good results both with a1c and wait throughout the entire 52 weeks.