Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: GLIMEPIRIDE (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Nathalie Billon, Study Director, Affiliation: Sanofi-Aventis
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Single Group Assignment
Primary outcome: Change in interstitial glucose levels between the observation and maintenance phases.
Secondary outcome: HbA1c and fasting blood glucose levels.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Paris, France
Additional Information
clinicalstudyresults.org
Starting date: October 2002
Ending date: October 2003
Last updated: March 26, 2008
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