- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00311077
Insulin Glulisine in Healthy Lean and Obese Subjects
December 4, 2009 updated by: Sanofi
Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects
Primary objective
- To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.
Secondary objective
- To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.
Study Overview
Study Type
Interventional
Phase
- Phase 1
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria :
- Normal HbA1c
- Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.
Exclusion criteria :
- Systemic concomitant medication
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: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the serum insulin glulisine concentration and insulin lispro concentration
Time Frame: During the Study Conduct
|
During the Study Conduct
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure blood glucose
Time Frame: During the study conduct
|
During the study conduct
|
To measure glucose infusion rate
Time Frame: During the study conduct
|
During the study conduct
|
To measure the serum C-peptide
Time Frame: During the study conduct
|
During the study conduct
|
Adverse events collection
Time Frame: from the inform consent signed up to the end of the study
|
from the inform consent signed up to the end of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2004
Primary Completion (Actual)
October 1, 2004
Study Registration Dates
First Submitted
March 2, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (Estimate)
April 5, 2006
Study Record Updates
Last Update Posted (Estimate)
December 7, 2009
Last Update Submitted That Met QC Criteria
December 4, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMR1964A_1502
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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