There are an estimated 497,100 children living with type I diabetes globally and incidence is increasing in many countries. Young children with type I diabetes can be difficult to treat as their needs are in constant flux during growth and development, with children aged six and under at greatest risk of severe hypoglycaemia and acute diabetes complications.
“Treating very young children with diabetes is challenging and it is crucial to strike a balance between achieving glucose targets, while minimising risk of side effects, particularly hypoglycaemia,” said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom and lead study investigator of the BEGIN® YOUNG 1 trial. “This CHMP recommendation for use of Levemir® in children as young as one, gives clinicians another option for this very young age group.”
The CHMP recommendation for expanded use of Levemir® in children is based on data from the BEGIN® YOUNG 1 trial, which evaluated the efficacy and long-term safety of Levemir® and insulin degludec in children and adolescents with type I diabetes. Results show that Levemir®, once or twice daily, in combination with insulin aspart, effectively improved long-term glycaemic control compared to baseline, and was well tolerated in children and adolescents with type I diabetes, including those as young as one year old.
“Novo Nordisk is committed to improving diabetes management for people with diabetes of all ages,” said Jakob Riis, executive vice president, Novo Nordisk. “Levemir® has been shown to be effective and well tolerated in children and adults with diabetes and we are pleased that once the European Commission approves this label expansion there will be another basal insulin option for children as young as one in the European Union.”
Novo Nordisk expects to receive marketing authorisation from the European Commission within two to three months.
About the study
The BEGIN® YOUNG 1 trial was a randomised controlled, 26-week open-label, treat-to-target trial (with a 26-week extension) investigating the efficacy and safety of Levemir®, given once or twice daily, and insulin degludec, given once daily, both in combination with bolus insulin aspart in children and adolescents aged 1–17 years with type I diabetes.
Levemir® and insulin degludec both achieved long-term glycaemic control as measured by mean change in HbA1c at 26 weeks. (2) Both treatments were well tolerated with comparable rates of adverse events and similar rates of overall and nocturnal hypoglycaemia. Weight (measured as SD score*) remained unchanged with Levemir®.