Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes

A Single-centre, Randomised, Double-blind, Cross-over Trial Comparing the Within-subject Variability of the Pharmacokinetic Profiles of Insulin Detemir and Insulin Glargine in Children and Adolescents With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.

Inclusion Criteria:

• Type 1 diabetes for at least 12 months
• Body mass index (BMI) for children (6 to 12 years): 15-20 kg/m^2 (both inclusive)
• Body mass index (BMI) for adolescents (13 to 17 years): 18-25 kg/m^2 (both inclusive)
• HbA1c (glycosylated haemoglobin) below 11.0% according to central laboratory results
• Current treatment with insulin at least twice daily

Exclusion Criteria:

• Any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes
• Receipt of any investigational product within the last four weeks
• Known or suspected allergy to trial products or related products