Date: 2015-08-26
Type of information: Initiation of the trial
phase: 3a
Announcement: initiation of the trial
Company: Novo Nordisk (Denmark)
Product: semaglutide
Action
mechanism: glucagon-like Peptide 1 (GLP-1) analogue. 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. Hence, the semaglutide molecule has a pharmacokinetic profile particularly suitable for once-weekly subcutaneous administration.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On August 26, 2015, Novo Nordisk announced the decision to initiate a phase 3a programme with oral semaglutide. The decision follows the encouraging results of the proof-of-concept phase 2 trial announced on 20 February 2015 and the subsequent consultations with regulatory authorities. Novo Nordisk intends to initiate a global phase 3a programme, named PIONEER, comprising seven trials with approximately 8,000 people with type 2 diabetes. The PIONEER programme will include six safety and efficacy trials and one trial for evaluating the cardio-vascular safety of oral semaglutide. The first trial in the programme is planned for initiation in 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 to once-daily oral anti-diabetic sitagliptin dose of 100 mg. The remaining six trials of the PIONEER programme are all expected to be initiated during 2016. In order to meet capacity requirements for current and future diabetes care products, including oral semaglutide, Novo Nordisk expects to invest an estimated $ 2 billion over the coming five years in two new production facilities; a new production facility for a range of active pharmaceutical ingredients in Clayton, North Carolina, US and a new drug-product facility in Måløv, Denmark. The final design and cost of the new production facilities will be presented for approval by the company's board of directors in 2016.
