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.