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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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: March 4, 2008
Last updated: March 26, 2008
Last verified: March 2008
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.

Condition Intervention Phase
Diabetes Mellitus Drug: GLIMEPIRIDE Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome 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. ]

Secondary Outcome Measures:
  • HbA1c and fasting blood glucose levels. [ Time Frame: Measured in the observation and maintenance phases, and change between the two phases. ]

Enrollment: 43
Study Start Date: October 2002
Study Completion Date: October 2003

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00633425

Paris, France
Sponsors and Collaborators
Study Director: Nathalie Billon Sanofi
  More Information Identifier: NCT00633425     History of Changes
Other Study ID Numbers: HOE490B_4001
Study First Received: March 4, 2008
Last Updated: March 26, 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors processed this record on August 18, 2017