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
Phase 4
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00633425
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in interstitial glucose levels between the observation and maintenance phases. The mean of 24 variations in average hourly glucose readings recorded by CGMS.
- Secondary Outcome Measures
Name Time Method HbA1c and fasting blood glucose levels. Measured in the observation and maintenance phases, and change between the two phases.
Trial Locations
- Locations (1)
Sanofi-Aventis
🇫🇷Paris, France