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.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00633425
First received: March 4, 2008
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

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: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c and fasting blood glucose levels. [ Time Frame: Measured in the observation and maintenance phases, and change between the two phases. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633425

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie Billon Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00633425     History of Changes
Other Study ID Numbers: HOE490B_4001
Study First Received: March 4, 2008
Last Updated: March 26, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 17, 2014