GLP-1 Diabetes Drug Shows Promise in Mid-Stage Trial

February 20, 2015
Ryan Marotta, Assistant Editor

Novo Nordisk has positive results from a completed phase 2 trial on the oral formulation of its investigational, long-acting human glucagon-like peptide-1 analogue.

Novo Nordisk today announced positive results from a completed phase 2 trial on the oral formulation of its investigational drug, semaglutide (OG217SC), a long-acting human glucagon-like peptide-1 (GLP-1) analogue that stimulates insulin and suppresses glucagon secretion.

The 26-week trial examined oral semaglutide’s dose range, escalation, efficacy, and safety compared with oral placebo and subcutaneous semaglutide in approximately 600 patients with type 2 diabetes.

The research team found that patient treated with oral semaglutide in 5 different doses ranging from 2.5 mg to 40 mg experienced a 0.7% to 1.9% improvement in HbA1C at 26 weeks, compared with HbA1C improvements of 1.9% and 0.3% with subcutaneous semaglutide and placebo, respectively.

The research team also discovered that patients treated with subcutaneous semaglutide experienced an average weight loss of approximately 6.5 kg, which was comparable to the weight loss experienced by those treated with the highest doses of oral semaglutide. Comparatively, patients treated with placebo experienced an average weight loss of just over 1 kg.

“We are very pleased with the results of this trial confirming the potential of semaglutide to treat type 2 diabetes, both as a once-weekly subcutaneous injection and as a once-daily tablet,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, in a press release. “This clinical proof of concept marks an important milestone for oral peptide therapy within the field of diabetes.”

The most common adverse events associated with the use of semaglutide included nausea and vomiting. While these gastrointestinal adverse events appeared to be dose-dependent and more prevalent with highest doses of oral semaglutide compared with subcutaneous semaglutide, they ultimately diminished over time.

Novo Nordisk plans to use these trial results to decide whether or not the GLP-1 diabetes drug will reach phase 3 development.