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BEGIN YOUNG 1 Trial: Tresiba (Insulin Degludec) Effective and Safe for Children and Young Adults

Tresiba, in combination with insulin aspart, effectively improved long-term glycemic control….

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The study investigated once-daily Tresiba versus insulin detemir, both in combination with bolus insulin aspart in a 52-week trial in children and adolescents with type 1 diabetes. The BEGIN YOUNG 1 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 glycemic control.

"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 Dr. Nandu Thalange, pediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom.

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 versus insulin detemir (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 degludec plus insulin aspart. Of note, patients on Tresiba had significantly lower rates of hyperglycemia with ketosis (p<0.05). Weight increased with Tresiba and remained unchanged with insulin detemir. Adverse event profiles were similar for insulin degludec and insulin detemir.

Practice Pearls:

  • Tresiba improves long-term glycemic control in children and young adults with type 1 diabetes.
  • Tresiba can be used once daily with flexibility in dosing time if needed. Injection doses should be separated by at least eight hours.

Thalange N, et al. Long-term efficacy and safety of insulin degludec in combination with bolus insulin aspart in children and adolescents with type 1 diabetes. Poster presented at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD), Vienna, Austria, 15-19 September 2014