DEVOTE: Tresiba Offers Same CV Safety, 40% Drop in Hypoglycemia vs Lantus

The study's lead author said that complications from cardiovascular disease remain an unmet clinical challenge in type 2 diabetes.

Insulin degludec, the ultra long-acting basal insulin from Novo Nordisk sold as Tresiba, offers the same level of cardiovascular (CV) safety as insulin glargine U100, but with a 40% reduction in severe hypoglycemia for adults with type 2 diabetes (T2D), according to trial results reported Monday.

Novo Nordisk had already reported topline results from DEVOTE, the first head-to-head, treat-to-target, event-driven trial involving 2 basal insulins, and it recently sought an updated label with FDA based on the results. The presentation at the 77th Scientific Sessions of the American Diabetes Association (ADA) offered a chance to dig deeper into the findings, which offered some surprises for scientists taking part in the study.

“The complications from cardiovascular disease remain an unmet clinical challenge for type 2 diabetes,” said Steven Marso, MD, of the Heart and Vascular Institute, HCA Midwest Health in Kansas City, Missouri, one of the study’s authors. During a press conference ahead of the presentation, he noted how the trial showed the need for those who spend their careers treating heart disease to recognize the impact of hypoglycemia—yet another example of how the fields of diabetes and cardiology overlapped at this year’s meeting.

“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,” said a study co-author, Berman Zinman, MD, of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto.

The FDA had asked for the trial to show that the newer generation of insulin was as safe as earlier ones, and the trial met the primary endpoint of noninferiority with insulin glargine for major CV events (heart attack, stroke, and CV death). The trial followed 7637 people with T2D for roughly 2 years.

Results from the secondary endpoints of DEVOTE included the significant reduction in the rate of severe hypoglycemia, as well as a 53% reduction for nocturnal severe hypoglycemia for insulin degludec, compared with insulin glargine. Incidents at night are especially feared by people with diabetes, particularly if they have lived with diabetes for a long time and are unlikely to awaken with symptoms. Severe hypoglycemia was defined simply as requiring the assistance of another person.

Findings for each component of the primary endpoint were:

· First occurrence of CV death, hazard ratio (HR, 0.96; 95% CI, 0.76; 1.21; P = .714).

· Non-fatal myocardial infarction, (HR, 0.85; 95% CI, 0.68-1.06; P = .150).

· Non-fatal stroke, (HR, 0.90; 95% CI, 0.65-1.23; P = .502).

Reference

Marso SP, McGuire DK, Zinman B, Pratley R, Buse J. Cardiovascular safety of insulin degludec vs insulin glargine in patients with type 2 diabetes at high risk of cardiovascular events (DEVOTE) trial results. Presented at the 77th Scientific Sessions of the American Diabetes Association, June 9-13, San Diego, California.