Novo Nordisk’s basal insulin analogue Levemir (insulin detemir ) has proved that it 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 hypoglycaemic risk.

The new clinical trial data has been  published in Paediatric Diabetes. It is a sub-group analysis of a full cohort of children aged  2–16 years. The full cohort is expected to be published in a relevant journal later this year.

No basal insulin analogue is currently recommended for  young children, and Novo Nordisk is now working to update the Levemir label. “Children with type 1 diabetes under six years have the greatest likelihood of severe hypoglycaemia and the highest risk of acute diabetes complications. This is why it is  important to examine the safety for this very young age group,” says Lead Investigator Dr Nandu Thalange, Norfolk and Norwich University Hospital, Norwich, United Kingdom.

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 hypoglycaemia compared to those taking human basal insulin (neutral protamine Hagedorn insulin) and NovoRapid (24-hour: 50.6 versus 78.3 episodes per patient-year; nocturnal hypoglycaemia: 8.0 versus 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 hypoglycaemic risk differences follow the same patterns that were revealed in the overall cohort which differences proved to be statistically significant. 3 No patients treated with Levemir had a severe hypoglycaemic episode, whereas there were six reported episodes in three patients treated with human basal insulin.

“This is the first randomized controlled clinical trial with basal insulin which was conducted in paediatric patients and involved a significant proportion of children under six years old with type 1 diabetes. The results suggest clinically relevant safety benefits of Levemir for these very young patients when compared with human basal insulin,” informed Dr Thalange.

In terms of glycaemic control, HbA1c was similar between treatment groups at baseline (8.2% vs 8.1%), and changed little over one year (8.1% versus  8.3%). Fasting plasma glucose was similar at baseline (8.44 vs 8.56 mmol/l) and decreased during the trial in both arms (-1.0 vs -0.45 mmol/l). Levemir was associated with a change in weight Z score (body weight standardized for age and gender) of -0.17 whilst in case of human basal insulin the change was+0.03.

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 hypoglycaemic risk.

“If our application for a label update is successful, Levemir will be the first basal insulin analogue with an indication extended to this very young patient population. It will also be the second Novo Nordisk insulin analogue after NovoRapid that will cover this group”, stated Kirstine Brown Frandsen, corporate vice president, Global Medical Affairs, Novo Nordisk.