EU Finds Novo Nordisk’s Detemir Safe for Children Aged 2-5

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The European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the extended use of Novo Nordisk’s basal insulin analogue, insulin detemir, in children with type 1 diabetes, aged two to five years. The CHMP decision was made after the review of data demonstrating 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 hypoglycemia: 8.0 vs 17.4 episodes per patient year).
 
Because the study was conducted on a small number of patients no statistical analyses have been conducted, but the hypoglycemic 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 hypoglycemic episode, whereas there were six reported episodes in three patients treated with human basal insulin.
Novo Nordisk anticipates that the European Commission will extend the marketing authorization 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 randomized clinical trial.      
 

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