Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine in blinded phase 3b trial in people with type 2 diabetes
Bagsværd, Denmark, 29 January 2016 - Novo Nordisk today announced the headline results from SWITCH 2, the first of two 2x32-weeks randomised, double-blind, cross-over, treat-to-target 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 (ie 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.
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 Tresiba® in the full treatment period.
In the trial, Tresiba® appeared to have a safe and well-tolerated profile. Adverse events were comparable between the two treatment arms. The most common adverse events were nasopharyngitis and upper respiratory tract infections.
"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" says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "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".
Novo Nordisk expects to announce headline results of SWITCH 1 later in the first quarter of 2016.
About SWITCH 1 and 2
The two 2x32-weeks randomised, double-blind, cross-over, treat-to-target trials were initiated in January 2014 with purpose of comparing the safety and efficacy of Tresiba® and insulin glargine. The overall purpose of the trials is to document the hypoglycaemia profile in type 1 diabetes and type 2 diabetes respectively, compared to insulin glargine. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine in combination with oral antidiabetics.
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Company announcement No 6 / 2016