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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00353691 |
To compare the change in glycemic control from baseline to endpoint (last available posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes receiving either glimepiride or metformin as monotherapy.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: glimepiride Drug: metformin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Glimepiride Versus Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus: A Single Blind Comparison Study |
Estimated Enrollment: | 100 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | November 2004 |
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Subjects meeting any of the following criteria were not to be included in the study:
Study ID Numbers: | HOE 490/4038 |
Study First Received: | July 17, 2006 |
Last Updated: | July 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00353691 |
Health Authority: | United States: Food and Drug Administration |
Glimepiride Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Immunologic Factors Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Agents Anti-Arrhythmia Agents Immunosuppressive Agents Pharmacologic Actions |