DEVOTE trial: Insulin degludec similar to insulin glargine in cardiovascular safety, with reduced hypoglycemia

Insulin degludec (IDeg), a new, ultra-long acting insulin product, may significantly reduce severe hypoglycemia in patients with type 2 diabetes, and has a cardiovascular safety profile similar to that of insulin glargine U100 (IGlar), according to data presented at the 77th Scientific Sessions of the American Diabetes Association.

IDeg is a new generation, once-daily, injectable basal insulin that provides a duration of action of at least 42 hours.

Researchers of the phase 3, multi-center, international, randomized, double-blind DEVOTE study sought to test the relative cardiovascular safety of IDeg compared with IGlar U100 when added to a standard of care regimen for people with type 2 diabetes.

Between October 2013 and November 2014, they included 7,637 people from 20 countries and 436 sites with type 2 diabetes at high risk of major adverse cardiovascular events (MACE). Of these patients, 6,506 had prior cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors.

Patients were randomized to either injectable daily IDeg or IGlar, plus other medications the patients were already taking.

First occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, occurred with a hazard ratio of 0.91 in favor of IDeg relative to IGlar, with no statistically significant difference between the two treatments.

In addition, treatment with IDeg resulted in 27% fewer patients experiencing an episode of severe hypoglycemia and a 40% overall reduction of total episodes of severe hypoglycemia. Furthermore, IDeg patients had a 53% reduction in the rate of nocturnal severe hypoglycemia.

“The findings of the DEVOTE study are in line with previous clinical trials comparing insulin degludec to insulin glargine U100, so we are pleased to be able to provide conclusive evidence regarding the safety of insulin degludec for patients with type 2 diabetes who are at high risk of cardiovascular complications,” said study investigator Dr. Steven Marso, MD, chief medical officer for HCA Midwest Health cardiovascular services.

“These results will provide reassurance for both people with type 2 diabetes and their health care providers that this new insulin product has comparable cardiovascular safety to IGlar,” said study investigator Dr. John Buse, MD, PhD, director of the Diabetes Center, director of the NC Translational and Clinical Sciences Institute, and executive associate dean for clinical research at the University of North Carolina School of Medicine in Chapel Hill. “It is exciting that with IDeg, patients can achieve positive glycemic control along with a major reduction in the risk of severe hypoglycemia, particularly nocturnal severe hypoglycemia.”