DEVOTE: degludec offers CV equivalence and hypoglycemic superiority to glargine
medwireNews: The ultralong-acting, once-daily basal insulin degludec has equivalent cardiovascular (CV) safety to that of insulin glargine and reduces hypoglycemia risk in patients with type 2 diabetes, the DEVOTE investigators have reported at the American Diabetes Association scientific sessions in San Diego, California.
“These results were achieved at equivalent glycemic control in the two groups,” Steven Marso (Research Medical Center, Kansas City, Missouri, USA) and team write in the simultaneous publication in The New England Journal of Medicine.
The patients were an average of 65.0 years old, with an average diabetes duration of 16.4 years; around 63% had established CV disease only, 16% had chronic kidney disease only, and 20% had both.
During a median observation time of 1.99 years, 8.5% of the 3818 patients randomly assigned to receive once-daily degludec had a primary CV endpoint (CV death or nonfatal myocardial infarction or stroke). This was statistically noninferior to the rate of 9.3% among the 3819 patients assigned to once-daily glargine.
“Whether these findings can be extrapolated to longer exposure, to patients with a lower risk of cardiovascular events, or both is uncertain,” note the researchers.
Severe hypoglycemia, defined as that requiring the assistance of another person to give carbohydrate or glucagon, occurred at a rate of 3.70 and 6.25 events per 100 patient–years in the degludec and glargine groups, giving a significantly reduced rate ratio of 0.60. The same was true for nocturnal severe hypoglycemia, which occurred at corresponding rates of 0.65 and 1.40 events per 100 patient–years, with a rate ratio of 0.47.
Both insulins used in the trial are long-acting and given once daily, which helps patients to achieve more stable glucose levels and less hypoglycemia.
“The reduction in severe hypoglycemia that is reported in our trial and in previous trials that have compared degludec with glargine probably results from the improved pharmacodynamic profile of degludec,” says the team.
Patients’ average baseline glycated hemoglobin level was 8.4%, and this fell to 7.5% during the course of the trial, with no significant difference between the groups. The estimated dose of basal insulin was a nonsignificant 2 units higher for degludec than glargine and the initiation of other antidiabetic medications did not differ between the groups.
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