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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014