Tresiba® demonstrated no increased risk of major cardiovascular (CV) events and significant reduction in rates of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial.
DEVOTE is a long-term, a multinational, randomized, 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 with type 2 diabetes at high risk of CV disease were randomized to treatment with either Tresiba® or insulin glargine U100 in a vial in addition to standard of care.
The result from the trial was presented at the American Diabetes Association’s 77th Scientific Sessions (ADA 2017) and also published simultaneously in the New England Journal of Medicine.
In the trial, Tresiba® demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycemia: 27% fewer patients in the Tresiba® treated group experienced an episode of severe hypoglycemia, resulting in a 40% overall reduction of total episodes of adjudicated severe hypoglycemia. Furthermore, patients in the Tresiba® treated group experienced a 54% reduction in the rate of nocturnal severe hypoglycemia.
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 hypoglycemia compared to insulin glargine U100,” said Dr. Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada and a member of the DEVOTE Steering Committee.
“Risk of cardiovascular disease and hypoglycemia 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.”