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Glucovance

Phase 3FDA approved 2000

Diabetes Mellitus, Non-Insulin-Dependent | Small molecule | Metabolic |Bristol-Myers Squibb Company|Trials Updated: Apr 15, 2011

Glucovance development status

FDA approval Jul 31, 2000
Approval holderBristol Myers Squibb
ApplicationNDA021178
Highest phase Phase 3

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Glucovance clinical trials

Glucovance · 1 trial · 1 indication

Phase 3 1
NCT00035542A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.Diabetes Mellitus, Non-Insulin-Dependent
COMPLETED- Analytics
PHASE3COMPLETED
A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.
Diabetes Mellitus, Non-Insulin-DependentUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
Glucovance (metformin HCl/glyburide)DRUG -
metformin HClDRUG -
glyburideDRUG -
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Eligibility Criteria

Age Range9 Years to 16 Years
SexALL
Healthy VolunteersNo
Study Sites50

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%

Countries:United States
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Frequently asked questions about Glucovance

What is Glucovance used for?

Glucovance is used for Diabetes Mellitus, Non-Insulin-Dependent, also known as type 2 diabetes. It is a small molecule combination therapy developed by Bristol-Myers Squibb Company. The drug combines metformin HCl and glyburide, two oral agents that help manage blood glucose in patients with type 2 diabetes.

Who makes Glucovance?

Glucovance is made by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb is the developer of the metformin HCl and glyburide combination product.

What phase is Glucovance in?

Glucovance has been studied in Phase 3 clinical development. The Phase 3 trial NCT00035542 evaluated the safety and efficacy of Glucovance compared to metformin and glyburide in children and adolescents with type 2 diabetes. That trial is now completed.

What clinical trials is Glucovance in?

Glucovance has been evaluated in one completed Phase 3 clinical trial, NCT00035542. The study was titled A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes. It was conducted in the United States and enrolled participants aged 9 years and older.