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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00035542 |
The purpose of this clinical research study is to see if Glucovance, a medication currently approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and effectively in children 9 to 16 years of age.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: Glucovance (metformin HCl/glyburide) Drug: metformin HCl Drug: glyburide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Ages Eligible for Study: | 9 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Children ages 9-16 years with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, with or without oral hypoglycemic therapy, and have an HbA1c greater than 6.4%
Study ID Numbers: | CV138-059 |
Study First Received: | May 3, 2002 |
Last Updated: | September 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00035542 |
Health Authority: | United States: Food and Drug Administration |
Diabetes Mellitus, Type II |
Glyburide Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |