Degludec is noninferior to glargine regarding the incidence of major cardiovascular events among patients with type 2 diabetes at high cardiovascular risk, according to data published in the New England Journal of Medicine and presented at the American Diabetes Association 77th Scientific Sessions, held in San Diego, California.
Steven P. Marso, MD, from the Research Medical Center in Kansas City, and colleagues conducted a double-blind, treat-to-target, event-driven cardiovascular outcomes trial, in which 7,637 patients with type 2 diabetes were randomly assigned to receive insulin degludec (n=3,818) or insulin glargine U100 (n=3,819) once a day between dinner and bedtime.
At the start of the study, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, the mean glycated hemoglobin level was 8.4 ± 1.7%, and 83.9% of the patients were receiving insulin. In addition, 85.2% of the participants had established cardiovascular disease, chronic kidney disease, or both.
The primary outcome of the study was the first occurrence of an adjudicated major cardiovascular event with a prespecified noninferiority of 1.3. Cardiovascular events included mortality from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
A cardiovascular event occurred in 8.5% of patients receiving degludec, and in 9.3% of patients receiving glargine (hazard ratio, 0.91). At 24 months, the mean glycated hemoglobin level was 7.5 ± 1.2% in each group. However, the mean fasting plasma glucose level was significantly lower among patients taking degludec compared with patients taking glargine (128 ± 56 vs 136 ± 57 mg per deciliter).
The researchers also observed prespecified adjudicated severe hypoglycemia in 4.9% of patients receiving degludec and in 6.6% of patients receiving glargine (rate ratio, 0.60). Adverse event rates did not differ between the 2 groups.
- Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017 Jun 12. 2017. doi:10.1056/NEJMoa1615692