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People with either type 1 or type 2 diabetes treated with Tresiba had fewer episodes of low blood sugar (hypoglycaemia) compared with people on insulin glargine U100 regardless of whether they had achieved blood sugar targets.
The announcement follows new post-hoc analyses from the SWITCH 1 and 2 trials, which was presented at the International Diabetes Federation (IDF) Annual Congress in Abu Dhabi.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said: “Achieving target blood sugar levels can be a constant challenge for people with diabetes treated with insulin, and this is made even more complex by the risk of hypoglycaemia.
“Tresiba has consistently been shown to provide stable blood sugar control while at the same time reducing hypoglycaemia compared with insulin glargine U100; it is very encouraging to see that treatment with Tresiba helps people to achieve blood sugar control with fewer episodes of hypoglycaemia regardless of their blood sugar levels in this analysis.”
The findings of these analyses are consistent with the results of the main SWITCH trials which demonstrated significantly lower rates of overall symptomatic hypoglycaemia versus insulin glargine U100 in people with type 1 and type 2 diabetes.
About the new analyses
The analyses, based on the recent SWITCH trials, separated people into two groups depending on whether they had achieved target blood sugar levels (defined as HbA1c of 7.0% or less) during the maintenance period of the trial. Target blood sugar levels are those recommended by the joint guidelines of the American Diabetes Association and the European Association for the Study of Diabetes.
SWITCH 1 and SWITCH 2 were two phase 3b, 64-week, double-blind, randomised, treat-to-target, 2-period crossover trials that investigated the hypoglycaemia profile of Tresiba compared with insulin glargine U100 in people with type 1 and type 2 diabetes, respectively. The trial design included a titration period in which the doses of study treatments (Tresiba or insulin degludec U100) were gradually increased over a 16 week period, followed by a 16 week maintenance period during which a constant dose of study treatment was maintained. The primary endpoint was the number of severe or blood glucose-confirmed symptomatic hypoglycaemic episodes observed in participants during the maintenance period.