Positive opinion on the use of Levemir® (insulin detemir) in children with type 1 diabetes aged two to five years

Today the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the extended use of Novo Nordisk’s basal insulin analogue, insulin detemir, in children aged two to five years with type 1 diabetes.

Data reviewed by the CHMP demonstrate that insulin detemir is an equally efficacious treatment option for two to five-year-old children with type 1 diabetes, compared with NPH1,2.

The pre-specified and stratified subgroup data show that children aged two to five years treated with insulin detemir plus a fast-acting insulin analogue, insulin aspart, experienced a lower rate of all-day and nocturnal hypoglycaemia compared to those taking human basal insulin (neutral protamine Hagedorn insulin) and insulin aspart (24-hour: 50.6 vs 78.3 episodes per patient year; nocturnal hypoglycaemia: 8.0 vs 17.4 episodes per patient year).

Although, owing to the small number of patients in this group, no statistical analyses have been conducted, the hypoglycaemic risk differences follow the same patterns that were revealed in the overall cohort where differences proved to be statistically significant. No patients treated with insulin detemir had a severe hypoglycaemic episode, whereas there were six reported episodes in three patients treated with human basal insulin.

“Safety is of the utmost importance when treating young children with type 1 diabetes. Reducing risk of hypoglycaemia – particularly at night – is a vital part of modern management of young children with diabetes. Children under six years are at the highest risk of severe hypoglycaemia and other acute diabetes complications, and any treatment which improves safety – not least in this group – is to be welcomed3,” says Dr Nandu Thalange of the Norfolk and Norwich University Hospital, Norwich, United Kingdom.

Novo Nordisk anticipates that the European Commission will extend the marketing authorisation within the coming months, which will make insulin detemir the only basal insulin analogue for the use in this young patient group supported by results from a randomised clinical trial.