Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01497574
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Insulin detemir insulin detemir - Insulin detemir insulin glargine - Insulin glargine insulin detemir - Insulin glargine insulin glargine -
- Primary Outcome Measures
Name Time Method Area under the insulin concentration curve (AUC)
- Secondary Outcome Measures
Name Time Method Maximum insulin concentration (Cmax) Time to maximum insulin concentration (tmax) Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Hannover, Germany