The EC recently approved insulin degludec (Tresiba) for diabetes in children and adolescents aged one to 17 years.

The approval is based largely on the Begin Young 1 trial, in which 174 children received insulin degludec once daily with mealtime insulin aspart, while 176 received insulin detemir once or twice daily with mealtime insulin aspart. The main phase of the study lasted 26 weeks. A 26-week extension phase treated 152 and 128 children with insulin degludec and detemir respectively.

At the start of the study, the children had, on average, a four-year history of diabetes, HbA1c of 8.1 per cent and fasting plasma glucose (FPG) of 8.7mmol/L. After 52 weeks, no statistically significant difference emerged between mean HbA1c with insulin degludec (7.9 per cent) and detemir (7.8 per cent). Mean FPG declined by 1.29mmol/L with insulin degludec, but rose by 1.10mmol/L in those who received insulin detemir.

The estimated treatment difference (1.62mmol/L) was statistically significant. The authors concluded that insulin degludec “provided equivalent glycaemic control” to insulin detemir “with a greater reduction in FPG” and a lower risk of hyperglycaemia with ketosis.

Data presented at the Diabetes UK Professional Conference held in London in March