Rates of Hypoglycemia Compared with Tresiba, Insulin Glargine

Treatment with Tresiba (insulin degludec injection; Novo Nordisk) resulted in significantly lower rates of overall, nocturnal, and severe hypoglycemia vs. insulin glargine U-100, according to new data from two Phase 3b SWITCH trials.

The randomized, double-blind, crossover, treat-to-target trials were initiated to compare the safety profile and efficacy of Tresiba and insulin glargine U-100. The overall purpose was to report the hypoglycemia profile in type 1 and type 2 diabetes.

In SWITCH 1 (n=501), patients with type 1 diabetes who took Tresiba had a 11% rate reduction in overall symptomatic blood glucose confirmed hypoglycemic episodes (95% CI: 0.85, 0.94), a 36% rate reduction in nocturnal blood glucose confirmed symptomatic hypoglycemic episodes (95% CI: 0.56, 0.73), and a 35% rate reduction in severe hypoglycemia (95% CI: 0.48, 0.89) during the maintenance period, all compared with insulin glargine U-100. These analyses demonstrated similar results for the full treatment period.

In SWITCH 2 (n=721), patients with type 2 diabetes had a 30% rate reduction in overall blood glucose confirmed symptomatic hypoglycemic episodes (95% CI: 0.61, 0.80), and a 42% rate reduction in nocturnal blood glucose confirmed symptomatic hypoglycemic episodes (95% CI: 0.46, 0.74), all compared with insulin glargine U-100. In the maintenance period, the Tresiba arm showed lower rates of severe hypoglycemia than insulin glargine U-100. For the full treatment period, there was a 51% rate reduction in severe hypoglycemia in patients receiving Tresiba vs. insulin glargine U-100 (95% CI: 0.26, 0.94).

For the reduction of HbA1c, Tresiba was non-inferior to insulin glargine U-100 in both treatment periods for SWITCH 1 and 2. The insulin doses at end-of-trial were similar at the end of each treatment period in both trials.

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