Headline results from SWITCH 2 trial of Tresiba announced
Posted: 29 January 2016 | | No comments yet
SWITCH 2 is the first of two trials comparing the safety and efficacy of Tresiba (insulin degludec) and insulin glargine in patients with type 2 diabetes…
Novo Nordisk has announced headline results from SWITCH 2, the first of two trials comparing the safety and efficacy of Tresiba (insulin degludec) and insulin glargine.
The overall purpose of the trial was to compare the hypoglycaemia occurrence in people with type 2 diabetes treated with Tresiba or insulin glargine.
In the trial, 721 people with type 2 diabetes were randomised to cross-over treatment with Tresiba and insulin glargine in combination with metformin. The timing of the daily injections of both Tresiba and insulin glargine was randomised equally to take place either in the morning or evening. The primary end-point of the trial was the number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes during the maintenance period (after 16 weeks of treatment) in each treatment period.
From a mean baseline of 7.6%, the trial showed non-inferiority in HbA1c reduction of Tresiba compared to insulin glargine, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments. Likewise, the end-of-trial insulin doses were similar at the end of treatment in the two treatment periods.
Trial met its primary endpoint
The observed rate of severe or blood glucose confirmed symptomatic hypoglycemia was 186 events per 100 patient years exposed to Tresiba and 265 events per 100 patient years exposed to insulin glargine during the maintenance period. This reduction was statistically significant, and the trial thus met its primary endpoint by demonstrating a reduction of 30% when people were treated with Tresiba compared to insulin glargine.
The observed rate of severe or blood glucose symptomatic nocturnal confirmed hypoglycaemia in the maintenance period was 55 events per 100 patient years exposed to Tresiba and 94 events per 100 patient years exposed to insulin glargine, corresponding to a 42% reduction with Tresiba compared to insulin glargine and showing statistical significance on this confirmatory secondary end-point.
The confirmatory secondary endpoint of proportions of subjects experiencing severe hypoglycaemia during the maintenance period did not reach statistical significance. However, the supportive end-point, rate of severe hypoglycaemia, showed a 46% reduction with Tresiba in the maintenance period and a statistical significant reduction of 51% with the therapy in the full treatment period.
Commenting on the results, Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “We are excited about these trial results, which in a blinded setting confirm the significant reduction in the risk of hypoglycaemia for Tresiba compared to insulin glargine. We look forward to reporting the outcome of the SWITCH 1 trial in people with type 1 diabetes and to evaluating the results from both trials.”