Efficacy and Safety of Degludec vs. Glargine in Type 2 Diabetes



Title: Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes

Marso, S.P. et al.


 

What You Need to Know:

In patients with type 2 diabetes at high risk for cardiovascular events, degludec, an ultralong-acting basal insulin dosed once daily, was found to be noninferior to insulin glargine with respect to the occurrence of major cardiovascular events.

Trial Design:

  • Double-blind, treat-to-target, event-driven phase 2 study compared the safety and efficacy of degludec to insulin glargine in patients with type 2 diabetes at high risk for cardiovascular events
  • 7637 patients were randomized to receive insulin degludec (n=3818) or insulin glargine U100 (n=3819) administered daily between dinner and bedtime
  • Primary composite outcome: “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”
  • Multiplicity-adjusted secondary outcome: adjudicated severe hypoglycemia

Key Outcomes:

  • “The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P<0,001 for noninferiority)”
  • Mean glycated hemoglobin level at 24 months: 7.5±1.2% for both groups
  • Mean fasting plasma glucose level at 24 months: 128±56 mg/dL for the degludec group vs 13657 mg/dL for the glargine group (P<0.001)
  • Adjudicated severe hypoglycemia: experienced by 4.9% of degludec patients (187/3818) vs 6.6% of glargine patients (252/3819) (absolute difference: 1.7%; rate ratio: 0.60; P<0.001 for superiority; OR: 0.73; P<0.001 for superiority)
  • No difference in the rates of adverse events observed between the two groups