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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.

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035542
First received: May 3, 2002
Last updated: April 7, 2011
Last verified: April 2011

May 3, 2002
April 7, 2011
December 2001
October 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00035542 on ClinicalTrials.gov Archive Site
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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.
Not Provided

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.

Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
  • Drug: Glucovance (metformin HCl/glyburide)
  • Drug: metformin HCl
  • Drug: glyburide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2003
October 2003   (final data collection date for primary outcome measure)

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%

Both
9 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035542
CV138-059
Not Provided
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Bristol-Myers Squibb
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Not Provided
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP