Tresiba® demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs insulin glargine U-100

New Orleans, US, 11 June 2016 – New findings from the two phase 3b SWITCH trials showed that treatment with long-acting basal insulin Tresiba® (insulin degludec injection U-100) resulted in significantly lower rates of overall, nocturnal and severe hypoglycaemia compared with insulin glargine U-100. 1,2 Results from the SWITCH 1 and 2 trials, the first completed double-blinded basal insulin studies evaluating the safety profile and efficacy of Tresiba® versus insulin glargine U-100, 1,2 were presented today at the American Diabetes Association 76th Scientific Sessions in New Orleans, US.

In SWITCH 1, patients with type 1 diabetes taking Tresiba® compared with insulin glargine U-100 experienced: a rate reduction of 11% in overall symptomatic blood glucose (BG) confirmed hypoglycaemic episodes (95% confidence interval CI: 0.85; 0.94); a rate reduction of 36% in nocturnal BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.56; 0.73), and a rate reduction of 35% severe hypoglycaemia (95% CI: 0.48; 0.89) during the maintenance period.1 All of the above analyses showed similar results in the full treatment period.

In SWITCH 2, patients with type 2 diabetes taking Tresiba® compared with insulin glargine U-100 experienced a rate reduction of 30% in overall BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.61; 0.80) and a rate reduction of 42% in nocturnal BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.46; 0.74). The above analyses showed significant results in the full treatment period. In the maintenance period, there was a trend towards lower rates of severe hypoglycaemia in favour of Tresiba® vs insulin glargine U-100. In the full treatment period, a significant 51% rate reduction in severe hypoglycaemia was observed in patients receiving Tresiba® vs insulin glargine U-100 (95% CI: 0.26; 0.94). 2

“Hypoglycaemia is an ongoing challenge for people with type 1 and type 2 diabetes,” said Dr. Wendy Lane, lead SWITCH 1 study investigator and clinical endocrinologist at Mountain Diabetes and Endocrine Center in Asheville, N.C., U.S. “These findings are important for the diabetes community, and add to the existing body of evidence for Tresiba®.”

Tresiba® (IDeg) was non-inferior to insulin glargine U-100 (IGlar) in reducing HbA1c in both treatment periods for both SWITCH 1 and 2 trials. 1-3 (SWITCH 1 treatment period 1: IDeg 6.92% vs IGlar U-100 6.78%; SWITCH 1 treatment period 2: IDeg 6.95% vs IGlar U-100 6.97%; SWITCH 2 treatment period 1: IDeg 7.06% vs IGlar U-100 6.98%; SWITCH 2 treatment period 2: IDeg 7.08% vs IGlar U-100 7.11%).1-3 The end-of-trial insulin doses were similar at the end of each treatment period in both trials. The most common adverse events (≥5%) included nasopharyngitis, upper respiratory tract infections and hypoglycemia. 3-5

About SWITCH 1 and 2 The two phase 3b, 2×32-weeks randomised, double-blind, crossover, treat-to-target trials were initiated in January 2014 to compare the safety profile and efficacy of Tresiba® and insulin glargine U-100. The overall objective was to document the hypoglycaemia profile in type 1 diabetes and type 2 diabetes, respectively. During the maintenance period, the primary endpoint studied was the number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. The two secondary endpoints included: the number of treatment emergent severe or BG confirmed nocturnal episodes and the proportion of subjects with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U-100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U-100 in combination with oral antidiabetic drugs.

About hypoglycaemia Hypoglycaemia is a frequent complication in people with type 1 and type 2 diabetes when low levels of blood glucose in the blood deprive muscles, cells and the brain of the energy needed to function. 6 Hypoglycaemia can be triggered by multiple factors including taking too much insulin, not following the prescribed meal schedule or participating in unusually strenuous or prolonged exercise.

About Tresiba® Tresiba® (insulin degludec injection U-100) is a once-daily basal insulin that provides a duration of action beyond 42 hours. 7,8 It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time when needed.7,9,10 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally. It was most recently approved by the FDA in the United States on 26 September 2015.

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