Novo Nordisk wants to submit its new type 2 diabetes tablet in 2019, first phase trial hits aim

February 22, 2018 Off By Dino Mustafić

Novo Nordisk has completed the first phase 3a trial, PIONEER 1, with oral semaglutide, for treating type 2 diabetes in the adults.

Novo Nordisk has announced the headline results from its trial, the first phase 3a trial with oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet. The global 26-week trial investigated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo in 703 people with type 2 diabetes.

The company said that the trial achieved its primary objective according to the primary statistical principle by demonstrating significant and superior improvements in HbA1c (long-term blood sugar) for all three doses of oral semaglutide compared to placebo. Moreover, the 14 mg dose of oral semaglutide demonstrated significant and superior weight loss versus placebo, weight loss was observed for the 7 mg and 3 mg doses but did not reach statistical significance.

“We are very encouraged by the results of the PIONEER 1 trial, which confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. He added that the company looks to submit it for further regulations in 2019.