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Oral Diabetes Treatment Semaglutide Enters Phase III Trial
Novo Nordisk is set to begin a phase III study of semaglutide, its diabetes drug that can be taken orally rather than by injection, after “encouraging” results were reported in previous trials, according to a report from Reuters.
Semaglutide is a glycagon-like peptide-1 (GLP-1) antagonist.
Novo also initiated the development of the world’s first once-weekly insulin injection last year.
In a 26-week, phase II study, reported in February, diabetic patients treated with 40 mg of oral semaglutide demonstrated a 1.9% reduction in hemoglobin A1C (HbA1C), a marker of glucose levels. In comparison, 1 mg of weekly injected semaglutide also resulted in a 1.9% reduction in HbA1C, and placebo lowered HbA1C by 0.3%. At that time, Novo said the oral version also led to weight loss comparable with that of weekly semaglutide, which helped patients lose more than 14 pounds from a baseline of approximately 203 pounds.
The first study in the phase III PIONEER program will begin in the first quarter of 2016 and will investigate the efficacy and safety of once-daily oral semaglutide doses of 3 mg, 7 mg, and 14 mg compared with sitagliptin (100 mg once daily). The remaining six trials in the program are also expected to be initiated during 2016.
Approximately 387 million people have diabetes worldwide, according to the International Diabetes Federation, a number expected to increase by 205 million by 2035.
Source: Reuters; August 26, 2015.