Hypoglycemia Rates Compared for Two Long-Acting Insulins

Researchers assessed whether insulin degludec was non-inferior or superior to insulin glargine U100 in lowering symptomatic hypoglycemic episodes
Researchers assessed whether insulin degludec was non-inferior or superior to insulin glargine U100 in lowering symptomatic hypoglycemic episodes

Treatment with insulin degludec, compared to insulin glargine U100, reduced the risk of overall symptomatic hypoglycemia in patients with type 1 and type 2 diabetes having at least one hypoglycemic risk factor, according to a study published in JAMA.

A team of researchers aimed to assess whether insulin degludec was non-inferior or superior to insulin glargine U100 in lowering the rate of symptomatic hypoglycemic episodes. 

SWITCH 1 was a double-blind, randomized, cross-over non-inferiority trial (n=501) that enrolled adults with type 1 diabetes with at least one hypoglycemic risk factor for two 32-week treatment periods consisting of a 16-week titration and a 16-week maintenance period. Study patients were randomized to either once-daily insulin degludec followed by insulin glargine U100 or to insulin glargine U100 followed by insulin degludec; they were randomized to morning or evening dosing within each treatment sequence. 

Researchers measured the rate of overall severe or blood glucose-confirmed (<56mg/dL) symptomatic hypoglycemic episodes during the maintenance period (primary endpoint). Key secondary endpoints were the rate or nocturnal symptomatic hypoglycemic episodes and proportion of patients with severe hypoglycemia during the maintenance period.  

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Seventy-nine percent of patients (n=395) completed the trial. The rates of overall symptomatic hypoglycemia were 2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec group vs. 2462.7 episodes per 100 PYE in the insulin glargine U100 group (rate ratio [RR] 0.89, 95% CI: 0.85–0.94 P<0.001 for non-inferiority and superiority) during the maintenance period. 

The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE in the insulin degludec group vs. 428.6 episodes per 100 PYE in the insulin glargine U100 group (RR 0.64, 95% CI: 0.56–0.73; P<0.001 for non-inferiority and superiority). The study also found that fewer patients in the insulin degludec group had severe hypoglycemia during the maintenance period compared to the insulin glargine U100 group (10.3% vs. 17.1%; P=0.002). 

SWITCH 2 was a double-blind, treat-to-target cross-over trial (n=721) of type 2 diabetes patients with at least one hypoglycemic risk factor who had prior therapy with basal insulin with or without oral antidiabetic drugs. This study also included two 32-week treatment periods; the primary endpoint was the rate of overall symptomatic hypoglycemic episodes during the maintenance period. 

About 80% of patients (n=580) completed the trial. The rate of overall symptomatic hypoglycemia was 185.6 episodes per 100 PYE in the insulin degludec group vs. 265.4 episodes per 100 PYE in the insulin glargine U100 group (RR 0.70, 95% CI: 0.61–0.80; P<0.001) during the maintenance period. The proportion of patients with hypoglycemic episodes were 22.5% vs. 31.6%, respectively.  

The rates of nocturnal symptomatic hypoglycemia were 55.2 episodes per 100 PYE in the insulin degludec group vs. 93.6 episodes per 100 PYE in the insulin glargine U100 group (RR 0.58, 95% CI: 0.46–0.74; P<0.001). The study also found that fewer patients in the insulin degludec group had severe hypoglycemia during the maintenance period compared to the insulin glargine U100 group (1.6% vs. 2.4%).

For more information visit jamanetwork.com.