Today, 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 basal insulin Levemir (detemir), both in combination with bolus insulin Novolog (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) and the results show that Tresiba in combination with Novolog (Novorapid) effectively improved long-term glycemic control.
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 Levemir (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 Levemir (p<0.05) was achieved. Both regimens had similar rates of overall and nocturnal hypoglycemia, the rate of severe hypoglycemia was numerically higher with insulin Tresiba plus Novolog. Of note, patients on Tresiba had significantly lower rates of hyperglycaemia with ketosis (p<0.05). Weight increased with Tresiba and remained unchanged with Levemir. Adverse event profiles were similar for Tresiba and Levemir.
