Date: 2014-09-16
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD)
Company: Novo Nordisk (Denmark)
Product: Tresiba® (insulin degludec)
Action
mechanism: Tresiba® (insulin degludec) is a once-daily basal insulin that provides an ultra-long duration of action beyond 42 hours.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: 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.
Latest
news: * On September 16, 2014, 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 control1. 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 achieved. Both regimens had similar rates of overall and nocturnal hypoglycaemia, the rate of severe hypoglycaemia was numerically higher with insulin degludec plus insulin aspart1. 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.
