San Diego, US, 12 June 2017 - Novo Nordisk today 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).1
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.1
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).1
“In the DEVOTE trial degludec demonstrated no increase in the risk of major cardiovascular events and significant reductions in the rates of severe and nocturnal severe hypoglycaemia compared to insulin glargine U100,” said Dr Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada and member of the DEVOTE Steering Committee. “Risk of cardiovascular disease and hypoglycaemia are important concerns for those with type 2 diabetes and the results from DEVOTE add to the mounting evidence that will play an important role in treatment decisions.”
The safety profile of Tresiba® in DEVOTE was generally consistent with previous Tresiba® clinical trials.1 In DEVOTE, systematic collection of adverse events was limited to serious adverse events, adverse events leading to permanent discontinuation of investigational product (5.2% of patients in the Tresiba® arm and 5.8% of patients in the insulin glargine U100 arm), medication errors leading to serious adverse events and adverse events related to technical complaints.
*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.1
About DEVOTE
DEVOTE is a long-term, multi-national, randomised, double-blind and event-driven trial conducted to confirm the CV safety of Tresiba® (insulin degludec) compared to insulin glargine U100. In the trial, 7,637 people (Tresiba®: n=3,818, insulin glargine U100: n=3,819) with type 2 diabetes at high risk of CV disease were randomised to treatment with either Tresiba® or insulin glargine U100 in vial in addition to standard of care.1
The primary endpoint in DEVOTE was time from randomisation to the first occurrence of a three-component composite CV outcome comprising CV death, non-fatal myocardial infarction or non-fatal stroke. Secondary endpoints included severe hypoglycaemia, nocturnal severe hypoglycaemia, HbA1c and fasting plasma glucose.1
About Tresiba®
Tresiba® (insulin degludec) is a once-daily basal insulin that provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.2,3 It provides low within-day and day-to-day variability and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100.1,2 On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.2 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is now commercially available in more than 50 countries.
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