Effect of Insulin Degludec vs Glargine U100 on Hypoglycemia in T1D



Title: Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes

Lane, W et al.


 

What You Need to Know:

According to results obtained from the SWITCH 1 clinical trial, treatment with insulin degludec over 32 weeks reduced the rate of overall symptomatic hypoglycemic episodes compared to insulin glargine U100 in patients with type 1 diabetes at risk for hypoglycemia.

Trial Design:

  • Double-blind, crossover, non-inferiority study compared insulin degludec to insulin glargine U100 by assessing their ability to reduce the rate of symptomatic hypoglycemic episodes in patients with type 1 diabetes and 1 risk factor for hypoglycemia
  • 501 patients were randomized (1:1) to receive insulin degludec then insulin glargine U100 (n = 249) or insulin glargine U100 then insulin degludec (n = 252) and “randomized 1:1 to morning or evening dosing within each treatment sequence”
  • The study was carried out over 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 (overall severe or blood glucose confirmed [<56mg/dL]) that occurred during the maintenance period
  • Secondary endpoints: nocturnal symptomatic hypoglycemic episode rate, percent of patients that experienced severe hypoglycemia during the maintenance period
  • “The noninferiority criterion for the primary end point and for the secondary end point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided statistical testing for superiority was conducted”

Key Outcomes:

  • Rates of overall symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 patients: 2200.9 episodes/100 person-years' exposure (PYE) vs 2462.7 episodes/100 PYE, respectively (RR: 0.89; 95% CI: 0.85, 0.94; P<0.001 for non-inferiority; P<0.001 for superiority; rate difference: -130.31 episodes/100 PYE; 95% CI: -193.5, -67.16)
  • Rates of nocturnal symptomatic hypoglycemia for insulin degludec vs insulin glargine U100 patients: 277.1 episodes/100 PYE vs 428.6 episodes/100 PYE, respectively (RR: 0.64; 95% CI: 0.56, 0.73; P<0.001 for non-inferiority; P<0.001 for superiority; rate difference: -61.94 episodes/100 PYE; 95% CI: -83.85, -40.03)
  • Severe hypoglycemia: experienced by 10.3% of insulin degludec patients (95% CI: 7.3%, 13.3%) vs 17.1% of insulin glargine U100 patients (95% CI: 13.4%, 20.8%) during the maintenance period (P=0.002; risk difference: -6.8%; 95% CI: -10.8%, -2.7%)