Updated results of DEVOTE Phase III trial of Tresiba (insulin degludec injection 100 U/mL) in type 2 diabetes patients with high risk CV disease- Novo Nordisk

Novo Nordisk has announced the primary results from DEVOTE the first randomised, double-blind, treat-to-target, event-driven trial comparing two basal insulins, Tresiba (insulin degludec injection 100 U/mL) and insulin glargine U100, in adults with type 2 diabetes at high risk of cardiovascular (CV) disease. The trial demonstrated that Tresiba met the primary endpoint of non-inferiority compared with insulin glargine U100 for major adverse CV events (MACE) with a hazard ratio (HR) of 0.91 (95% confidence interval [CI]: 0.78; 1.06, p=0.209). Additionally, the findings for each component of MACE were consistent with the primary endpoint, including first occurrence of CV death (HR=0.96, 95% CI: 0.76; 1.21, p=0.714), non-fatal myocardial infarction (HR=0.85, 95% CI: 0.68; 1.06, p=0.150) or non-fatal stroke (HR=0.90, 95% CI: 0.65; 1.23, p=0.502). Results from the trial, involving 7,637 people with type 2 diabetes followed for approximately two years, were presented at the American Diabetes Association's 77th Scientific Sessions (ADA 2017) and also published simultaneously in the New England Journal of Medicine.

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 (both p<0.001). Additionally, post hoc analyses showed: similar levels of glycaemic control with an end of trial HbA1c estimated treatment difference of 0.01% (p=0.779) between the two treatment groups and significantly lower fasting plasma glucose levels with Tresiba after 2 years vs. insulin glargine U100 (estimated treatment difference -7.2 mg/dL, p<0.001). The safety profile of Tresiba in DEVOTE was generally consistent with previous Tresiba clinical trials.

Severe hypoglycaemia was defined as an episode requiring assistance of another person, and nocturnal severe defined as between the hours of 00:01-05:59, inclusive.

See- "Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes"- Steven P. Marso, M.D., Darren K. McGuire, M.D., Bernard Zinman, M.D., Neil R. Poulter, F.Med.Sci., Scott S. Emerson, M.D., Ph.D. et al., for the DEVOTE Study Group*-June 12, 2017DOI: 10.1056/NEJMoa1615692.