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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01497574
First received: December 20, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

December 20, 2011
December 20, 2011
May 2005
October 2005   (final data collection date for primary outcome measure)
Area under the insulin concentration curve (AUC) [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Maximum insulin concentration (Cmax) [ Designated as safety issue: No ]
  • Time to maximum insulin concentration (tmax) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin detemir
    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)
  • Drug: insulin glargine
    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)
  • Experimental: Insulin detemir
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin glargine
  • Active Comparator: Insulin glargine
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01497574
NN304-1633, 2004-001692-19
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Lisbet Westergaard Novo Nordisk A/S
Novo Nordisk A/S
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP