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Novo Nordisk’s semaglutide succeeds in two phase 3a type 2 diabetes trials

PBR Staff Writer Published 21 June 2018

Novo Nordisk said that oral semaglutide succeeded in two phase 3a trials by registering statistically significantly greater reductions in HbA1c and weight in adults with type 2 diabetes.

Semaglutide, which is a human glucagon-like peptide-1 (GLP-1) receptor agonist, was evaluated in comparison to Victoza (1.8mg liraglutide) and placebo in the Pioneer 4 trial and with sitagliptin 100mg in the Pioneer 7 trial.

Both the trials assessed semaglutide for the treatment of type 2 diabetes.

The 52-week Pioneer 4 trial featured 711 type 2 diabetes patients whose condition was inadequately controlled on metformin, with or without an SGLT-2 inhibitor.

Pioneer 4 met its primary goal by showing 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.

Pioneer 7, also met its primary goal by proving semaglutide to be statistically significant and superior to sitagliptin 100mg in the portion of patients achieving the American Diabetes Association (ADA) treatment target of HbA1c under 7% at week 52.

Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said: "With the significant one-year results in a real-world dose setting, oral semaglutide was superior to sitagliptin by documenting a greater proportion of people achieving the ADA target.

"At the same time, we have shown that oral semaglutide is even more efficacious in lowering glucose and body weight than the most widely used injectable GLP-1 treatment, Victoza".

Earlier, this year, semaglutide, branded as Ozempic, was approved by the European Commission for the treatment of adults with type 2 diabetes. Prior to that, in December 2017, Novo Nordisk secured approval for semaglutide injection from the US Food and Drug Administration to improve glycaemic control in adults with type 2 diabetes mellitus.

In another development, the Danish pharma company entered into a research collaboration and option agreement with the US-based Kallyope to discover peptide therapeutics for the treatment of obesity and diabetes.

As per the terms of the agreement, Novo Nordisk can license exclusive worldwide rights to develop and commercialize a maximum of six products discovered in the collaboration.


Image: Novo Nordisk headquarters in Bagsværd, Denmark. Photo: courtesy of Novo Nordisk A/S.