Novo Nordisk's Tresiba shows long-term efficacy and safety in diabetic children and adolescents

Danish diabetes care giant Novo Nordisk (NOV: N) announced positive new data from the BEGIN YOUNG 1 trial today, at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) taking place in Vienna, Austria.

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 one to less than 18 years). The results show that Tresiba in combination with insulin aspart effectively improved long-term glycemic control.

Potential new treatment option for youngsters

"When treating children and adolescents with type 1 diabetes, it is critical that the right balance between glycemic 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 Nandu Thalange, pediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, UK.

The BEGIN YOUNG 1 trial was a randomized 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 hypoglycemia, the rate of severe hypoglycemia was numerically higher with insulin degludec plus insulin aspart1. Of note, patients on Tresiba had significantly lower rates of hyperglycemia with ketosis (p<0.05)1. Weight (measured as SD score ) increased with Tresiba and remained unchanged with insulin detemir. Adverse event profiles were similar for insulin degludec and insulin detemir.