Novo Nordisk says 'DEVOTE' trial meets primary goal
Novo Nordisk announced primary results from DEVOTE, the first randomised, double-blind, treat-to-target, event-driven trial comparing two basal insulins, Tresiba and insulin glargine U100, in adults with type 2 diabetes at high risk of cardiovascular disease. The trial demonstrated that Tresiba met the primary endpoint of non-inferiority compared with insulin glargine U100 for major adverse CV events with a hazard ratio of 0.91. Additionally, the findings for each component of MACE were consistent with the overall endpoint, including first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke. Results were presented at the American Diabetes Association's annual meeting. Results from the secondary endpoints of the trial showed a significant reduction in the rate of severe -- 40% -- and nocturnal severe -- 53% -- hypoglycaemia with Tresiba vs. insulin glargine U100. Additionally, post hoc analyses showed similar levels of glycaemic control with an end of trial A1C estimated treatment difference of 0.01% between the two treatment groups and significantly lower fasting plasma glucose levels with Tresiba after 2 years vs. insulin glargine U100. The safety profile of Tresiba in DEVOTE was generally consistent with previous Tresiba clinical trials.