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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: metformin HCl; Drug: Glucovance (metformin HCl/glyburide); Drug: glyburide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035542

CV138-059

Details and patient eligibility

About

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.

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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%