- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00566124
Basal Insulins - Pharmacodynamics
November 30, 2007 updated by: University of Aarhus
No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design.
After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion.
C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period.
Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DK
-
Aarhus, DK, Denmark, 8000
- Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- BMI 20 - 50 kg/m2
- Blood pressure < 140/90 mmHg
- signed informed consent
- Caucasien
Exclusion Criteria:
- Diabetes or other disease
- Alcohol or drug abuse
- Smoking
- Use of prescription drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Insulin detemir
|
0.4 U/kg bw insulin detemir injected s.c. in the thigh.
Other Names:
|
Active Comparator: 2
Insulin glargine
|
0.4 U/kg bw insulin glargine injected s.c. in the thigh
Other Names:
|
Active Comparator: 3
NPH insulin
|
0.4 U/kg bw NPH insulin injected s.c. in the thigh
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ole E. Schmitz, DMSc, University of Aarhus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
November 30, 2007
First Submitted That Met QC Criteria
November 30, 2007
First Posted (Estimate)
December 3, 2007
Study Record Updates
Last Update Posted (Estimate)
December 3, 2007
Last Update Submitted That Met QC Criteria
November 30, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Opus 1
- 2004-41-4474
- 20040188
- 2612-2731
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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