Date: 2015-02-20
Type of information: Completion of the trial
phase: 2
Announcement: completion of the trial
Company: Novo Nordisk (Denmark)
Product: OG217SC - oral formulation of semaglutide
Action
mechanism: peptide/glucagon-like peptide analog. Semaglutide is a human GLP-1 (Glucagon-Like Peptide-1) analogue developed for once-weekly treatment of type 2 diabetes patients. The mechanism behind blood glucose lowering and reduction of body weight follows the same principles as liraglutide (Victoza®); however, with a longer intrinsic circulation half-life. The molecule is in development for once-weekly subcutaneous use and for once-daily oral administration for the treatment of type 2 diabetes. The oral formulation, OG217SC, is provided in a tablet formulation with an absorption-enhancing excipient, SNAC. SNAC is an absorptionenhancing excipient included in the Eligen® Carrier Concept. The Eligen® technology is licenced from Emisphere Technologies.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On February 20, 2015, Novo Nordisk announced that it has successfully completed the phase 2 trial for OG217SC; an oral formulation of the long-acting GLP-1 analogue semaglutide, investigating dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in around 600 people with type 2 diabetes treated for 26 weeks.From a mean baseline HbA1c of 7.9%, people 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. By comparison, people treated with a dose of 1 mg subcutaneous semaglutide or placebo achieved improvements of 1.9% and 0.3% respectively. Confirming the primary end-point of the trial, all doses of oral semaglutide were statistically significantly superior to placebo. Furthermore, from a mean baseline weight of 92 kg, people treated with subcutaneous semaglutide experienced a weight loss of around 6.5 kg, which was comparable to the weight loss experienced by the people treated with the highest doses of oral semaglutide. People treated with placebo experienced a weight loss of just over 1 kg. In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were related to the gastrointestinal system, primarily nausea and vomiting, and diminished over time. The gastrointestinal adverse events appeared to be dose-dependent and were more prevalent for the highest doses of oral semaglutide compared to subcutaneous semaglutide. No other apparent differences between the treatment groups were observed with respect to overall adverse events and standard safety parameters. Based on these results, Novo Nordisk will initiate consultations with regulatory authorities subsequent to which a decision of whether to progress OG217SC into phase 3 development will be made.
