Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride...
Date First Received: March 4, 2008
Last Updated: March 26, 2008
Verified by: Sanofi-Aventis, March 2008
Clinical Trial Phase: Phase 4 | Start Date: October 2002
Overall Status: Completed
Estimated Enrollment: 43
Brief Summary
Condition Keyword(s):
Intervention(s):
Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment
Intervention(s) in this Clinical Trial
- Drug: GLIMEPIRIDE
Outcome Measures for this Clinical Trial
Primary Measures
- Change in interstitial glucose levels between the observation and maintenance phases.
- Time Frame: The mean of 24 variations in average hourly glucose readings recorded by CGMS.
Safety Issue?: No
- Time Frame: The mean of 24 variations in average hourly glucose readings recorded by CGMS.
Secondary Measures
- HbA1c and fasting blood glucose levels.
- Time Frame: Measured in the observation and maintenance phases, and change between the two phases.
Safety Issue?: No
- Time Frame: Measured in the observation and maintenance phases, and change between the two phases.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Men or women aged 35 to 70 years
- Having given their consent
- Type 2 diabetics (HBA1c greater than 6.5%
- Fasting glycaemia greater than 1.40 g/l) not controlled by Metformin for at least 6 weeks.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 35 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Nathalie Billon Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633425
Study ID Number: HOE490B_4001
ClinicalTrials.gov Identifier: NCT00633425
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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