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A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

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ClinicalTrials.gov Identifier: NCT00035542
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : April 15, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: Glucovance (metformin HCl/glyburide) Drug: metformin HCl Drug: glyburide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : December 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035542


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Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Additional Information:
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00035542     History of Changes
Other Study ID Numbers: CV138-059
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
Diabetes Mellitus, Type II

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs