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NCT00633425 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00633425
Other study ID # HOE490B_4001
Secondary ID
Status Completed
Phase Phase 4
First received March 4, 2008
Last updated March 26, 2008
Start date October 2002
Est. completion date October 2003

Study information
Verified date March 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GLIMEPIRIDE

Locations
Country Name City State
France Sanofi-Aventis Paris

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in interstitial glucose levels between the observation and maintenance phases. The mean of 24 variations in average hourly glucose readings recorded by CGMS. No
Secondary HbA1c and fasting blood glucose levels. Measured in the observation and maintenance phases, and change between the two phases. No
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