At the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), Novo Nordisk announced new data from the BEGIN YOUNG 1 trial. The study investigates once-daily Tresiba (insulin degludec) versus insulin detemir, both in combination with bolus insulin aspart in a 52-week trial in children and adolescents with type 1 diabetes. This trial is the first to look into the long-term safety of Tresiba in children and adolescents (from age 1 to less than 18 years). The results show that Tresiba in combination with insulin aspart effectively improved long-term glycaemic control.

"When treating children and adolescents with type 1 diabetes, it is critical that the right balance between glycaemic control and side effect management is maintained to ensure the best possible long-term outcomes. These data show that Tresiba has the potential to offer youngsters with diabetes a new treatment option, which may help them achieve better control of their diabetes," said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom.

The BEGIN YOUNG 1 trial was a randomised controlled, 26 week open-label, treat-to-target trial (with a 26-week extension) investigating the efficacy and safety of Tresiba, given once daily, and insulin detemir, given once or twice daily, both in combination with bolus insulin aspart in children and adolescents with type 1 diabetes.

Tresiba met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c (p<0.05) at 26 weeks. In the 26-week extension a lower insulin dose and a significantly greater reduction in fasting plasma glucose (FPG) versus insulin detemir (p<0.05) was achieved1. Both regimens had similar rates of overall and nocturnal hypoglycaemia, the rate of severe hypoglycaemia was numerically higher with insulin degludec plus insulin aspart. Of note, patients on Tresiba had significantly lower rates of hyperglycaemia with ketosis (p<0.05)1. Weight (measured as SD score) increased with Tresiba and remained unchanged with insulin detemir1. Adverse event profiles were similar for insulin degludec and insulin detemir.

Tresiba (insulin degludec) is a once-daily basal insulin that provides an ultra-long duration of action beyond 42 hours. 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.

Tresiba has received regulatory approval in Argentina, Aruba, Bangladesh, Bosnia & Herzegovina, Brazil, Chile, Colombia, Costa Rica, El Salvador, the EU, Honduras, Hong Kong, Iceland, Israel, India, Japan, Kazakhstan, Lichtenstein, Lebanon, Macedonia, Mexico, Nepal, Norway, South Korea, Switzerland and Russia.