Tresiba® Trial Shows that People with Type 2 Diabetes who Avoid Severe Hypoglycaemia have a Reduced Risk of Death

LISBON, Portugal, September 15, 2017 /PRNewswire/ --

Symposium: S33

Novo Nordisk today announced new analyses from the multinational, double-blinded DEVOTE trial showing that people with type 2 diabetes who experience severe hypoglycaemia (low blood sugar levels) are at greater risk of death. The risk was four-fold higher 15 days after an event and two and a half-fold higher anytime following an episode of severe hypoglycaemia.^[1] In addition, results also showed that daily fluctuations in blood sugar levels in people with type 2 diabetes are associated with a higher risk of death. The results were presented at the European Association for the Study of Diabetes 53^rd Annual Meeting (EASD) and simultaneously published in Diabetologia.^[1],[2]

"Episodes of severe hypoglycaemia are not only distressing for patients and potentially dangerous, they are also associated with an increased risk of death," said Dr Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Canada and member of the DEVOTE Steering Committee. "These results highlight the importance of maintaining low variability in blood sugar levels and reducing the risk of severe hypoglycaemia when treating people with type 2 diabetes."

In the DEVOTE trial, Tresiba^® (insulin degludec) reduced the rate of severe hypoglycaemia by 40% and the rate of nocturnal severe hypoglycaemia by 53% compared to insulin glargine U100 in people with type 2 diabetes.^[3] Similar reductions were seen in the SWITCH 2 trial with 51% lower rates of severe hypoglycaemia during the full treatment period of the trial and a 42% reduction in the rate of nocturnal hypoglycaemia compared to insulin glargine U100 in people with type 2 diabetes.^[4]

Studies have also shown that Tresiba^® provides significantly lower variability in blood sugar levels compared to insulin glargine U100 and U300.^[5],[6]

About DEVOTE 
DEVOTE is a multinational, double-blinded clinical trial which investigated the cardiovascular safety of Tresiba^® compared with insulin glargine U100 over 104 weeks. DEVOTE is the first cardiovascular outcomes trial (CVOT) comparing two basal insulins and enrolled more than 7,500 people with type 2 diabetes. All participants had a high risk of, or existing, cardiovascular disease and were already receiving standard of care to reduce their cardiovascular risk.^[3] The trial demonstrated that Tresiba^® does not increase cardiovascular risk compared with insulin glargine U100, and provides a significant reduction in the rate of severe and nocturnal severe hypoglycaemia at similar levels of glycaemic control.^[3]