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Positive Results Reported for Oral Semaglutide in Diabetes Patients

Mid-stage trial compares oral and subcutaneous formulations

 Positive results have been reported from a phase II study of OG217SC (Novo Nordisk), an oral formulation of the long-acting glucagon-like peptide-1 (GLP-1) analogue semaglutide, compared with placebo or subcutaneous (SC) semaglutide in approximately 600 subjects with type-2 diabetes.

The trial investigated clinical efficacy and safety, along with the dosing range and dose escalation, in subjects receiving once-daily oral semaglutide, once-daily oral placebo, or once-weekly SC semaglutide for 26 weeks.

From a mean baseline hemoglobin A1c (HbA1c) of 7.9%, subjects treated with oral semaglutide in five different doses ranging from 2.5 mg to 40 mg achieved dose-dependent improvements in HbA1c of 0.7% to 1.9% after 26 weeks of therapy. In comparison, subjects treated with a 1-mg dose of subcutaneous semaglutide or placebo achieved improvements of 1.9% and 0.3%, respectively. All doses of oral semaglutide were significantly superior to placebo.

Further, from a mean baseline weight of 92 kg, subjects treated with SC semaglutide experienced weight loss of approximately 6.5 kg, which was comparable with the weight loss experienced by subjects treated with the highest doses of oral semaglutide. Subjects treated with placebo experienced weight loss of just over 1 kg.

Semaglutide appeared to be safe and well-tolerated. The most common adverse events (AEs) were related to the gastrointestinal (GI) system, primarily nausea and vomiting, and diminished over time. GI AEs appeared to be dose-dependent and were more prevalent for the highest doses of oral semaglutide compared with SC semaglutide. No other apparent differences among the treatment groups were observed with respect to overall AEs and standard safety parameters.

As a long-acting human GLP-1 analogue, semaglutide stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. The molecule is in development for once-weekly SC use and once-daily oral administration for the treatment of type-2 diabetes. The oral formulation is provided in a tablet with an absorption-enhancing excipient, SNAC.

Source: Novo Nordisk; February 20, 2015.

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