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.

First Received on March 4, 2008. Last Updated on March 26, 2008 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00633425

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

Drug Information available for: Glimepiride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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-Aventis

Investigators

Study Director:

Nathalie Billon

Sanofi-Aventis

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 - French Health Products Safety Agency

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 February 09, 2012