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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633425
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : March 28, 2008
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: GLIMEPIRIDE Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2002
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Glimepiride

Primary Outcome Measures :
  1. 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 :
  1. HbA1c and fasting blood glucose levels. [ Time Frame: Measured in the observation and maintenance phases, and change between the two phases. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633425

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Paris, France
Sponsors and Collaborators
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Study Director: Nathalie Billon Sanofi

Layout table for additonal information Identifier: NCT00633425     History of Changes
Other Study ID Numbers: HOE490B_4001
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors