Practice Update: Diabetes

ADA 2017 13

New, Ultra-Long-Acting Insulin Degludec Demonstrates Cardiovascular Safety and Reduces Risk of Severe Hypoglycemia A new, ultra-long-acting insulin product, insulin degludec, has been found to confer comparable cardiovascular safety to insulin glargine U100 and is also associated with significant reductions in severe hypoglycemia. This outcome of the phase 3, multicenter, international, randomized, double-blind Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) trial was reported at the American Diabetes Association’s 77th Scientific Sessions, from June 9–13. S teven Marso, MD, of HCA Midwest Health, Kansas City, Missouri, explained that the DEVOTE trial cardiovascular disease or chronic kidney disease, and the remainder had multiple cardiovascular risk factors.

Results of the study confirmed the cardiovascular safety of insulin degludec vs insulin glargine U100 by demonstrating noninferiority of major adverse cardiac events, such as first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (hazard ratio 0.91 in favor of insulin degludec vs insulin glargine, no statistically significant difference between the two treatments). Findings of DEVOTE also demonstrated the hypoglycemic benefit of insulin degludec. Severe hypoglycemia remains the most serious treatment risk of insulin therapy, and trials have suggested that insulin degludec is associated with a lower risk of hypoglycemia than insulin glargine U100. Severe hypoglycemia is the most serious acute complication of insulin treatment and can be lead to seizures, coma, and even death. Insulin degludec resulted in 27% fewer episodes of severe hypoglycemia and 40% overall reduction of total episodes of severe hypoglycemia. Patients in the insulin degludec group also experienced a 53% reduction in the rate of nocturnal severe hypoglycemia. All severe hypoglycemic events were evaluated and confirmed by external experts, and differences were all statistically significant. Dr Marso concluded, “Findings of the DEVOTE study are in line with previous clinical trials comparing insulin degludec vs insulin glargine U100, so we are pleased to provide conclusive evidence of the safety of insulin degludec for patients with type 2 diabetes at high risk of cardiovascular complications.” Coinvestigator John Buse, MD, PhD, of the University of North Carolina School of Medicine, Chapel Hill, said, “These results provide reassurance that this new insulin product confers comparable cardiovascular safety to insulin glargine. It is exciting that with insulin degludec, patients can achieve positive glycemic control along with a major reduction in the risk of severe hypoglycemia, particularly nocturnal severe hypoglycemia.”

evaluated the relative cardiovascular safety of insulin degludec vs insulin glargine U100 when added to a standard-of-care regimen for patients with type 2 diabetes. Insulin degludec is a new-generation, once- daily, injectable basal insulin that provides duration of action of at least 42 h. Insulin glargine is the most commonly prescribed insulin product for type 2 diabetes. Its cardiovascular safety was established in the 2012 Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. The DEVOTE trial evaluated 7637 patients with type 2 diabetes who were at high risk of major adverse cardiovascular events, for a period of approximately 2 years. The study enrolled patients between 2013 and 2014 at 436 sites in 20 countries. Of study participants, 6506 had suffered from prior

All patients were randomized to either injectable daily insulin degludec or insulin glargine, in addition to other medications the patients had been taking. Neither patient nor provider, however, knew which insulin formulation the patient was receiving/ administering. This blinding allowed for a robust exploration of safety and efficacy and is unique for comparative studies of insulin.

These results provide reassurance that this new insulin product confers comparable cardiovascular safety to insulin glargine.

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PracticeUpdate Editorial team.

VOL. 1 • NO. 2 • 2017