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Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01497574
First received: December 20, 2011
Last updated: January 27, 2017
Last verified: January 2017
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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:
Genetics Home Reference related topics:
type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
U.S. FDA Resources
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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01497574
Please refer to this study by its ClinicalTrials.gov identifier: 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 ) |
| Study First Received: | December 20, 2011 |
| Last Updated: | January 27, 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 |
ClinicalTrials.gov processed this record on August 23, 2017