BioCentury
ARTICLE | Clinical News

Oral semaglutide: Phase II data

February 23, 2015 8:00 AM UTC

A double-blind, international Phase II trial in about 600 Type II diabetics showed that all 5 doses of once-daily oral semaglutide met the primary endpoint of reducing HbA1c from baseline to week 26 vs. placebo. Specifically, oral semaglutide led to dose-dependent improvements in HbA1c of 0.7%-1.9% vs. 0.3% for placebo.

Once-weekly subcutaneous semaglutide led to a weight loss of around 6.5 kg from baseline, which was comparable to the weight loss experienced by patients treated with the highest doses of oral semaglutide. Placebo led to a weight loss just over 1 kg. Semaglutide was well tolerated. The most common adverse events reported were related to the gastrointestinal system, primarily nausea and vomiting. Patients received ascending doses of 2.5, 5, 10, 20 and 40 mg once-daily oral semaglutide, ascending doses of 0.25, 0.5 and 1 mg once-weekly subcutaneous semaglutide or placebo. Novo Nordisk plans to consult with regulatory authorities before deciding whether to progress the oral formulation of semaglutide into Phase III testing. ...