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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc

Criteria

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