Novo Nordisk unveiled new data for its long-acting insulin Tresiba at the American Diabetes Association 77th Scientific Sessions.
Investigators performed the first randomized, double-blind, treat-to-target, event driven trial named DEVOTE that tested Tresiba against insulin glargine U100 on 7,367 patients with type 2 diabetes with a high risk of cardiovascular (CV) disease over the course of two years.
Novo’s insulin product is a once-daily long-acting form of the diabetes treatment designed to improve glycemic control in patients that are one years of age or older. The insulin glargine U100, also known as Lantus, is a rival therapy prescribed for adults diagnosed with type 2 diabetes as well as adults and pediatric patients with type 1 diabetes to help control high blood sugar.
The Danish drugmaker revealed Tresiba achieved the primary endpoint of non-inferiority indicating patients taking this drug were no more likely to suffer from a significant adverse CV event like a non-fatal stroke or non-myocardial infarction.
Furthermore, Novo Nordisk’s medication met the secondary endpoints of the trial by producing a 40 percent reduction in severe hypoglycemia rates while nocturnal severe hypoglycemia rates dropped by 53 percent, according to the announcement.
“In the DEVOTE trial…[Tresiba]…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.”
Another one of Novo’s products, Xultophy 100/3.6, was able to achieve a noticeable impact on hypoglycemia levels. An estimated 66 percent of patients taking Xultophy 100/3.6, reached an A1c target of below 7 percent while there was also an 89 percent reduction in severe hypoglycemic events.
Results from the DEVOTE trial were published in The New England Journal of Medicine.
Filed Under: Drug Discovery