Novo Nordisk Announces Phase 3a Trial Results for Oral Semaglutide

On Friday, Novo Nordisk announced the results from PIONEER 1, a phase 3a trial featuring oral semaglutide for treatment of adults with type 2 diabetes (T2D). Oral semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue taken once daily as a tablet, making this investigational therapy the first oral treatment in this class.

In December 2017, the FDA approved the pre-filled pen version of Novo Nordisk’s semaglutide.

The global 26-week trial investigated the efficacy and safety of 3 mg, 7 mg, and 14 mg doses of oral semaglutide compared with placebo in 703 people with T2D.

Two approaches were used in evaluating the efficacy of oral semaglutide in the PIONEER 1 trial: a primary statistical principle required by recent regulatory guidelines evaluating the effect regardless of treatment adherence, and a secondary method of describing the effect if participants had adhered to treatment and did not initiate rescue medication.

The first objective was achieved by demonstrating a significant and superior improvement in glycated hemoglobin (A1C) for all 3 doses of oral semaglutide compared with placebo. In addition, the 14 mg dose also demonstrated significant weight loss compared with placebo; weight loss for 7 mg and 3 mg doses did not reach statistical significance.

When evaluating the secondary objective of the study, patients treated with 3 mg, 7 mg, and 14 mg doses of oral semaglutide achieved reductions in A1C of 0.8%, 1.3%, and 1.5%, respectively, compared with a reduction of 0.1% in people treated with placebo from a mean baseline of 8%. The American Diabetes Association (ADA) treatment target of A1C below 7% was achieved by 59%, 72%, and 80% of people treated with 3 mg, 7 mg, and 14 mg doses, respectively, compared with 34% of people treated with placebo.

Results showed oral semaglutide appeared to have a safe and well-tolerated clinical profile. The most common adverse effect for all 3 doses was mild to moderate nausea, which diminished over time. Between 5% and 16% of people treated experienced nausea.

“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. We look forward to providing data from the remaining 9 PIONEER trials throughout this year and an expected regulatory submission in 2019,” Mads Krogsgaard Thomsen, DVM, PhD, executive vice president and chief science officer of Novo Nordisk said in a statement.