Novo Nordisk has reported that its oral semaglutide medicine showed non-inferiority compared to placebo in major adverse cardiovascular events (MACE) during the PIONEER 6 clinical trial in type 2 diabetes patients.
Oral semaglutide is an investigational glucagon-like peptide-1 (GLP-1) analogue formulated as a pill reports Drug Development Technology.
The Trial was conducted globally, and its aim was to investigate the cardiovascular safety of oral semaglutide in patients with type 2 diabetes.
The study was a randomized, double-blinded, placebo-controlled, event-driven, pre-approval cardiovascular, outcomes trial compared the cardiovascular safety of the therapeutic to placebo when added to standard of care. It recruited a total of 3,183 patients at high risk of cardiovascular events.
The Trial Results
The trial’s primary endpoint was the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. PIONEER 6 met the endpoint with a hazard ratio of 0.79 in favor of semaglutide compared to placebo. The data is an aggregation of 137 first major adverse cardiovascular events and a median follow-up of 16 months. Novo Nordisk has reported that its oral semaglutide medicine showed non-inferiority compared to placebo in major adverse cardiovascular events (MACE) during the PIONEER 6 clinical trial in type 2 diabetes patients.
Cardiovascular death events were 15 with oral semaglutide compared to 30 with placebo, while non-fatal stroke events were 12 versus 16.
It should be noted that the number of non-fatal myocardial infarctions with the therapeutic was not significantly different to placebo, with the numbers being recorded at 37 and 31 respectively.
Moreover, there was a lower incidence of all-cause deaths in the oral semaglutide group as compared to the placebo group. Novo Nordisk reported that the safety profile was consistent with that of GLP-1 receptor agonist class and similar to subcutaneous semaglutide.
Overall Pioneer Program
The overall PIONEER clinical development program involved 9,543 type 2 diabetes patients in 10 clinical trials.