Back to resultsWithin-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin detemir
insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Insulin detemir
Insulin glargine
Arm Description
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01497574
Brief Title
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin detemir
Arm Type
Experimental
Arm Title
Insulin glargine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Area under the insulin concentration curve (AUC)
Secondary Outcome Measure Information:
Title
Maximum insulin concentration (Cmax)
Title
Time to maximum insulin concentration (tmax)
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18761644
Citation
Danne T, Datz N, Endahl L, Haahr H, Nestoris C, Westergaard L, Fjording MS, Kordonouri O. Insulin detemir is characterized by a more reproducible pharmacokinetic profile than insulin glargine in children and adolescents with type 1 diabetes: results from a randomized, double-blind, controlled trial. Pediatr Diabetes. 2008 Dec;9(6):554-60. doi: 10.1111/j.1399-5448.2008.00443.x. Epub 2008 Aug 27.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Within-subject Variability of Insulin Detemir in Children and Adolescents With Type 1 Diabetes
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