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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin detemir<br> | Drug: insulin detemir<br>* On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)<br>Drug: insulin glargine<br>* On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)<br>|
| Active Comparator: Insulin glargine<br> | Drug: insulin detemir<br>* On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)<br>Drug: insulin glargine<br>* On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin concentration curve (AUC) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum insulin concentration (Cmax) |  |  | 
| Time to maximum insulin concentration (tmax) |  |  | 
| Adverse events |  |  |