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Insulin Degludec (Tresiba) More Effective Than Insulin Glargine in Late-Stage Diabetes Trial
Positive results have been announced from SWITCH 2, the first of two 32-week, phase IIIb, randomized, double-blind, cross-over trials comparing the safety and efficacy of insulin degludec (Tresiba, Novo Nordisk) and insulin glargine in subjects with type-2 diabetes. The study’s primary objective was to compare the occurrence of hypoglycemia in the two treatment groups.
A total of 721 subjects with type-2 diabetes were randomly assigned to cross-over treatment with insulin degludec or insulin glargine in combination with metformin. The timing of the daily injections of both treatments was randomized equally to take place either in the morning or evening. The study’s primary endpoint was the number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycemia episodes during the maintenance period (i.e., after 16 weeks of treatment).
From a mean baseline of 7.6%, the trial showed noninferiority in hemoglobin A1c reduction with insulin degludec compared with insulin glargine. Likewise, the insulin doses were similar at the end of treatment.
The observed rate of severe or blood glucose-confirmed symptomatic hypoglycemia was 186 events per 100 patient-years exposed to insulin degludec and 265 events per 100 patient-years exposed to insulin glargine during the maintenance period. This reduction was statistically significant. The study thus met its primary endpoint by demonstrating a reduction of 30% when subjects were treated with insulin degludec compared with insulin glargine.
The observed rate of severe or blood glucose-confirmed symptomatic nocturnal hypoglycemia during the maintenance period was 55 events per 100 patient-years exposed to insulin degludec and 94 events per 100 patient-years exposed to insulin glargine, corresponding to a 42% reduction with insulin degludec and showing statistical significance on this secondary endpoint. In addition, another secondary endpoint, the rate of severe hypoglycemia, showed a 46% reduction with insulin degludec during the maintenance period and a statistically significant reduction of 51% with insulin degludec during the full treatment period.
Source: Novo Nordisk; January 29, 2016.