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Clinical Trials/NCT00633425
NCT00633425
Completed
Phase 4

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

Sanofi1 site in 1 country43 target enrollmentOctober 2002
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ConditionsDiabetes Mellitus
DrugsGLIMEPIRIDE

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Sanofi
Enrollment
43
Locations
1
Primary Endpoint
Change in interstitial glucose levels between the observation and maintenance phases.
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
October 2003
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sanofi

Eligibility 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • HbA1c and fasting blood glucose levels.(Measured in the observation and maintenance phases, and change between the two phases.)

Study Sites (1)

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