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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497574
First Posted: December 22, 2011
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin glargine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the insulin concentration curve (AUC)

Secondary Outcome Measures:
  • Maximum insulin concentration (Cmax)
  • Time to maximum insulin concentration (tmax)
  • Adverse events

Enrollment: 32
Study Start Date: May 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir 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)
Active Comparator: Insulin glargine 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)

  Eligibility

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497574


Locations
Germany
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01497574     History of Changes
Other Study ID Numbers: NN304-1633
2004-001692-19 ( EudraCT Number )
First Submitted: December 20, 2011
First Posted: December 22, 2011
Last Update Posted: January 30, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs