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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin detemir; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497574

NN304-1633

2004-001692-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Insulin detemir

Experimental group

Treatment:

Drug: insulin glargine

Drug: insulin detemir

Insulin glargine

Active Comparator group

Treatment:

Drug: insulin glargine

Drug: insulin detemir