Todd Hobbs, MD, chief medical officer of Novo Nordisk North America, discusses the results of PIONEER 4 at ADA 2019 in San Francisco, CA.
Use of oral semaglutide and results of the various Pioneer trials were a hot topic of discussion at the American Diabetes Association (ADA) 2019 Scientific Sessions in San Francisco, CA.
On Saturday, the results from PIONEER 4, which examined oral semaglutide versus liraglutide and placebo, were presented and investigators found that oral semaglutide was non-inferior to liralglutide in lowering HbA1c and superior to liraglutide and placebo in reducing body weight in patients with type 2 diabetes.
PIONEER 2 was a 52-week double-blind trial that involved a total of 711 patients. Of the 711, 285 were randomized to receive oral semaglutide 14mg, 284 received liraglutide 1.8mg, and 142 were randomized into the placebo group.
Novo Nordisk submitted a new drug application (NDA) to the US Food and Drug Administration for oral semaglutide in April. In an interview with MD Magazine at ADA 2019, Todd Hobbs, MD, chief medical officer of Novo Nordisk North America, said the company is excited to learn the status of their NDA in September.
MD Mag: What were the results of the Pioneer 4 trial?Hobbs: When we first started looking at semaglutide early on we knew it was a much more robust molecule from an A1c lowering and also from a weight perspective. When I started talking about oral semaglutide, I think the goal was that we could reproduce liraglutide in a pill and this trial actually showed we, in fact, did better than that. Going against our once-daily leader Victoza were looking to see if we could a have similar, if not a little better, A1c effect and then certainly hoping and expecting we would see a little more robust weight reduction and we did see that. Its encouraging that patients can now have an oral option for GLP1 therapy instead of having to go to injection.