Tresiba was not inferior to lantus regarding CVD outcomes. About 8,000 adults with type 2 diabetes and established cardiovascular disease were randomized to receive either tresiba or lantus. Baseline characteristics were; mean age 65, DM2 duration 16 years and A1c 8.5%. Participants were followed for about 2 years.
Other relevant findings; severe hypoglycemia and elevated fasting glucose were significantly lower among individuals receiving tresiba vs. lantus. Otherwise, adverse events were similar between the two study groups.
Unless cost or idiosyncratic reaction is an issue, patients would benefit more from tresiba than lantus.
N E J M
Background: Degludec is an ultralong-acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-to-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec.
Methods: We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-to-target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-to-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-adjusted secondary outcome.
Results: Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age = 65.0 years, the mean DM2 duration 16.4 years, and the mean A1c 8.4%; 83.9% of the patients were receiving insulin.
The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (HR 0.91; 95% CI 0.78-1.06; P<0.001 for noninferiority).
At 24 months, the mean A1c was 7.5% in each group,
Mean fasting glucose level was significantly lower in the degludec group than in the glargine group (128 vs. 136 mg/dL, P<0.001).
Prespecified adjudicated severe hypoglycemia occurred in 187 patients (4.9%) in the degludec group and in 252 (6.6%) in the glargine group, for an absolute difference of 1.7 percentage points (rate ratio, 0.60; P<0.001 for superiority; odds ratio, 0.73; P<0.001 for superiority).
Rates of adverse events did not differ between the two groups.
Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine with respect to the incidence of major cardiovascular events.