Status:
COMPLETED
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
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 adolescent...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01497574
Start Date
May 1 2005
End Date
October 1 2005
Last Update
January 30 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Hanover, Germany, 30173