Policy & Regulation
Novo Nordisk reports success in two Semaglutide phase 3a trials
22 June 2018 -

Denmark-based Novo Nordisk's oral Semaglutide has succeeded in two phase 3a trials by registering statistically significantly greater reduction in HbA1c and weight in adults with type 2 diabetes, it was reported yesterday.

The product is a human glucagon-like peptide-1 (GLP-1) receptor agonist and it was evaluated in comparison to Victoza (1.8mg liraglutide) and placebo in the Pioneer four trial and with sitagliptin 100mg in the Pioneer 7 trial. Both trials evaluated semaglutide for the treatment of type 2 diabetes.

The 52-week Pioneer four trial featured 711 type two diabetes patients whose condition was inadequately controlled on metformin, with or without an SGLT-2 inhibitor. Pioneer 4 met its primary goal by indicating a non-inferior reduction in HbA1c and statistically significant and superior weight loss at 26 weeks with 14mg oral semaglutide, in comparison to Victoza.

The GLP-1 analogue also delivered statistically significant and superior reductions in HbA1c and weight, in comparison to placebo. In the 52-week long Pioneer 7 trial, oral semaglutide was investigated with dose adjustment based on clinical evaluation of glycaemic control and drug tolerability. It was compared with the DPP-IV inhibitor 100mg sitagliptin in 504 people with type 2 diabetes, whose condition was inadequately controlled on 1-2 oral antidiabetics.

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