Effects of Insulin Degludec vs Glargine U100 on Hypoglycemia in T2D



Title: Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes

Wysham, C et al.


 

What You Need to Know:

According to results obtained from the SWITCH 2 clinical trial, 32-week treatment with insulin degludec reduced the rate of overall symptomatic hypoglycemia compared to insulin glargine U100 in patients with type 2 diabetes previously treated with insulin who were at risk for hypoglycemia.

Trial Design:

  • Double-blind, treat-to-target crossover study assessed whether insulin degludec was associated with a lower rate of hypoglycemic episodes compared to insulin glargine U100 in patients in type 2 diabetes with 1 risk factor for hypoglycemia who were treated previously with basal insulin +/- oral antidiabetic drugs
  • 721 patients were randomized (1:1) to receive insulin degludec then insulin glargine U100 (n = 361) or insulin glargine U100 then insulin degludec (n =360) and “randomized 1:1 to morning or evening dosing within each treatment sequence”
  • The study included two 32-week treatment periods, each consisting of a 16-week titration period and a 16-week maintenance period
  • Primary endpoint: rate of symptomatic hypoglycemic episodes that occurred during the maintenance period (severe or blood glucose confirmed [<56mg/dL])
  • Secondary endpoints: rate of nocturnal symptomatic hypoglycemic episodes that occurred between 12:01 AM and 5:59 AM (severe or blood glucose confirmed), percent of patients that experienced severe hypoglycemia during the maintenance period

Key Outcomes:

  • Rates of overall symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 patients: 185.6 episodes/100 person-years' exposure (PYE) vs 265.4 episodes/100 PYE, respectively (RR: 0.70; 95% CI: 0.61, 0.80; P<0.001; difference: -23.66 episodes/100 PYE; 95% CI: -33.98, -13.33); percent of insulin degludec vs insulin glargine U100 patients with hypoglycemic episodes: 22.5% vs 31.6%, respectively (difference: -9.1%; 95% CI: -13.1%, -5.0%)
  • Rates of nocturnal symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 patients: 55.2 episodes/100 PYE vs 93.6 episodes/100 PYE, respectively (RR: 0.58; 95% CI: 0.46, 0.74; P<0.001; difference: -7.41 episodes/100 PYE; 95% CI: -11.98, -2.85); percent of insulin degludec vs insulin glargine U100 patients with hypoglycemic episodes: 9.7% vs 14.7%, respectively (difference: -5.1%; 95% CI: -8.1%, -2.0%)
  • Severe hypoglycemia: experienced by 1.6% of insulin degludec patients (95% CI: 0.6%, 2.7%) vs 2.4% of insulin glargine U100 patients (95% CI: 1.1%, 3.7%) during the maintenance period (P=0.35; risk difference: -0.8%; 95% CI: -2.2%, 0.5%)
  • “Statistically significant reductions in overall and nocturnal symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 were also seen for the full treatment period”