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

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.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Childrens's Health System/Dept of PED/Diabetes/Endoncrinology, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Glucovance (metformin HCl/glyburide)

Drug

metformin HCl

Drug

Glyburide

Drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2003
First posted: May 6, 2002
Registry last updated: Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed