New clinical trial data just published in Pediatric Diabetes shows that Levemir (insulin detemir), Novo Nordisk’s basal insulin analogue, is an equally efficacious treatment option for two to five year-old children with type 1 diabetes, compared with human basal insulin, but is associated with lower hypoglycemic risk. Children with type 1 diabetes who are aged under six years have the greatest likelihood of severe hypoglycemia and the highest risk of acute diabetes complications. No basal insulin analogue is currently recommended for these young children, and Novo Nordisk is now working to update the Levemir label.
The pre-specified and stratified subgroup data show that children aged two to five years treated with Levemir plus a fast-acting insulin analogue, NovoRapid (insulin aspart), experienced a lower rate of all day and nocturnal hypoglycemia compared to those taking human basal insulin (neutral protamine Hagedorn insulin) and NovoRapid (24-hour: 50.6 vs 78.3 episodes per patient-year; nocturnal hypoglycemia: 8.0 vs 17.4 episodes per patient year). Although no statistical analysis has been conducted due to the low number of patients in this age group, the hypoglycemic risk differences follow the same patterns that were revealed in the overall cohort which differences proved to be statistically significant.No patients treated with Levemir had a severe hypoglycemic episode, whereas there were six reported episodes in three patients treated with human basal insulin.
In conclusion, the study investigators report that the data demonstrate, when compared to human basal insulin, Levemir plus NovoRapid is an equally efficacious treatment option for very young children and is associated with less hypoglycemic risk.