Comparable CV safety, reduced severe hypoglycaemia risk with insulin degludec vs insulin glargine
Insulin degludec had comparable cardiovascular safety and reduced the risk of severe hypoglycaemia compared with insulin glargine U100 in patients with type 2 diabetes and high cardiovascular risk, according to results of the DEVOTE* study.
“[Complications] from cardiovascular disease remain an unmet clinical need for people with type 2 diabetes,” said study investigator Dr Steven Marso, chief medical officer for HCA Midwest Health cardiovascular services, Kansas City, Missouri, US, who presented the findings of the phase III, multicentre (436 sites in 20 countries), head-to-head trial at the 77th Scientific Sessions of the American Diabetes Association (ADA 2017) held in San Diego, California, US.
“[Severe] hypoglycaemia is another very relevant safety issue for both providers and patients, and it is a goal of therapy to lower glucose values in a safe and effective way to reduce microvascular complications.”
“The [DEVOTE] trial demonstrated that [insulin] degludec was as safe as [insulin] glargine with respect to cardiovascular outcomes and safer with respect to hypoglycaemia risk,” he said.
Between October 2013 and November 2014, 7,637 patients with type 2 diabetes and at high risk of major adverse cardiovascular events (MACE; mean age 65 years, mean diabetes duration 16.4 years, mean HbA1c 8.4 percent) were randomized to receive insulin degludec (n=3,818) or insulin glargine U100 (n=3,819) once daily between dinner and bedtime in addition to standard-of-care therapy. Patients were followed up for a median 2 years.
Almost 84 percent of patients were receiving insulin at baseline and 85.2 percent of patients had chronic kidney disease, cardiovascular disease, or both.
Patients on insulin degludec did not experience an increase in the incidence of cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) compared with patients on insulin glargine U100 (8.5 percent vs 9.3 percent, hazard ratio [HR], 0.91, 95 percent confidence interval [CI], 0.78–1.06; p<0.001 for noninferiority). [ADA 2017, session 3-CT-SY22; N Engl J Med 2017;doi:10.1056/NEJMoa1615692]
Patients on insulin degludec also had a 40 percent reduction in the incidence of severe hypoglycaemia compared with patients on insulin glargine U100 (4.9 percent vs 6.6 percent, rate ratio [RR], 0.60, 95 percent CI, 0.48–0.76; p<0.001 for superiority, odds ratio, 0.73, 95 percent CI, 0.60–0.89; p<0.001 for superiority), as well as a 53 percent reduction in the incidence of severe nocturnal hypoglycaemia (1.0 percent vs 1.9 percent, RR, 0.47, 95 percent CI, 0.31–0.73; p<0.001).
“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 Marso.