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Novo Nordisk successfully completes fifth phase 3a trial with semaglutide in people with type 2 diabetes

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Additional Relevant Details The trial successfully achieved its objective by demonstrating that people treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.4% and 1.8% respectively, from a mean baseline HbA1c of 8.4%, compared with an improvement in HbA1c of 0.1% with placebo. Additionally, the end of trial insulin dose for people treated with 0.5 mg and 1.0 mg semaglutide was reduced by 10% and 15% respectively, compared with 3% for the placebo group. 61% of the people treated with 0.5 mg semaglutide and 79% of the people treated with 1.0 mg semaglutide achieved the treatment target of HbA1cbelow 7% set by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), compared with 11% of the people treated with placebo. From a mean baseline body weight of 92 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 3.7 kg and 6.4 kg respectively, compared with a weight loss of 1.4 kg for people treated with placebo. In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea. Nausea was reported by 11% of the people treated with 0.5 mg semaglutide and by 17% of the people treated with 1.0 mg semaglutide, compared with 5% of people treated with placebo. Severe or blood glucose-confirmed symptomatic hypoglycaemia was experienced by 8% and 11% of people treated with 0.5 mg or 1.0 mg once-weekly semaglutide respectively, compared with 5% in the placebo group. The discontinuation rate due to adverse events was 5% and 6% for people treated with 0.5 mg semaglutide and 1.0 mg semaglutide respectively, compared to 1% for people treated with placebo.
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Catalyst Date
Occurred on:
Feb 23, 2016
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Related Keywords Sustain, Glp-1 Analogue, Sustain5, Type 2 Diabetes, Semaglutide, Phase 3a Trial