CLINICAL TRIALS PROFILE FOR GLUCOVANCE

All Clinical Trials for GLUCOVANCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035542 ↗	A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.	Completed	Bristol-Myers Squibb	Phase 3	2001-12-01	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.
NCT00035568 ↗	A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes	Completed	Bristol-Myers Squibb	Phase 4	2002-02-01	The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes.
NCT00371306 ↗	Comparison of Glucovance to Insulin for Diabetes During Pregnancy	Unknown status	Regional Obstetrical Consultants	N/A	2002-09-01	Pregnant women with gestational or Type 2 diabetes who require medication are placed in one of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is checked 5 times per day, and medication adjusted by perinatologist according to glucose levels. The hypothesis is that patients will have similar or improved blood glucose control on an oral agent as compared to control on insulin.
NCT00476619 ↗	Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial	Terminated	Ortho Biotech Products, L.P.	Phase 4	2004-09-01	Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal Failure in Patients Receiving Intravenous Contrast Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin administration in the prevention or attenuation of contrast-induced acute renal failure. Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1, BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and correlate their expression with clinical outcomes Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial of a one-time dose of EPO. Subjects will be followed for seven days or until hospital discharge, whichever is longer. Total estimated study duration 3 years.
NCT00476619 ↗	Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial	Terminated	Brigham and Women's Hospital	Phase 4	2004-09-01	Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal Failure in Patients Receiving Intravenous Contrast Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin administration in the prevention or attenuation of contrast-induced acute renal failure. Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1, BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and correlate their expression with clinical outcomes Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial of a one-time dose of EPO. Subjects will be followed for seven days or until hospital discharge, whichever is longer. Total estimated study duration 3 years.

Clinical Trial Conditions for GLUCOVANCE

Condition Name

Condition Name for GLUCOVANCE
Intervention	Trials
Diabetes Mellitus, Non-Insulin-Dependent	2
Gestational Diabetes	2
Healthy	2
Contrast Induced Nephropathy	1

Condition MeSH

Condition MeSH for GLUCOVANCE
Intervention	Trials
Diabetes Mellitus	3
Diabetes, Gestational	2
Diabetes Mellitus, Type 2	2
Kidney Diseases	1

Clinical Trial Locations for GLUCOVANCE

Trials by Country

Trials by Country for GLUCOVANCE
Location	Trials
United States	35
Canada	2

Trials by US State

Trials by US State for GLUCOVANCE
Location	Trials
Texas	3
Tennessee	2
New York	2
Massachusetts	2
Illinois	2

Clinical Trial Progress for GLUCOVANCE

Clinical Trial Phase

Clinical Trial Phase for GLUCOVANCE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for GLUCOVANCE
Clinical Trial Phase	Trials
Completed	4
Terminated	2
Unknown status	1

Clinical Trial Sponsors for GLUCOVANCE

Sponsor Name

Sponsor Name for GLUCOVANCE
Sponsor	Trials
Teva Pharmaceuticals USA	2
Bristol-Myers Squibb	2
Brigham and Women's Hospital	1

Sponsor Type

Sponsor Type for GLUCOVANCE
Sponsor	Trials
Industry	5
Other	3

GLUCOVANCE Market Analysis and Financial Projection

Last updated: April 28, 2026

Glucovance: Clinical Trials Update, Market Analysis, and 5-Year Projection

Glucovance is the brand name for the fixed-dose combination of metformin hydrochloride + glibenclamide (glyburide). The combination targets two mechanisms for type 2 diabetes: metformin improves hepatic insulin sensitivity and reduces glucose production, while glibenclamide stimulates pancreatic insulin release. Commercially, the product sits in a competitive segment dominated by metformin backbones and incretin-based therapies, with differentiated demand driven by price, formulary access, and regional prescribing patterns.

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What is the current clinical development status for Glucovance?

Are there active, ongoing interventional trials for Glucovance?

No complete, trial-level update can be produced from the information in scope for this request.

Are there recent label-expansion or formulation-change trials?

No complete, trial-level update can be produced from the information in scope for this request.

Are there bioequivalence or pharmacokinetic (BE/PK) studies for Glucovance?

No complete, trial-level update can be produced from the information in scope for this request.

Bottom line

A market-grade clinical trials update requires current registry evidence (e.g., ClinicalTrials.gov or regional registries) with trial status, dates, endpoints, and site geography. Those data are not available in the input provided.

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What is the market position of Glucovance?

Where does Glucovance sit in the diabetes market?

Glucovance belongs to the oral combination therapy category for type 2 diabetes, using:

• Metformin (biguanide)
• Glibenclamide (glyburide) (sulfonylurea)

This places the product in a lower-acquisition-cost segment versus:

• DPP-4 inhibitors
• SGLT2 inhibitors
• GLP-1 receptor agonists
• Dual incretin therapies

What drives demand?

Glucovance demand tends to track:

• Formulary adoption of metformin+sulfonylurea as step-up therapy
• Affordability constraints in cost-sensitive markets
• Provider switching behavior (metformin monotherapy to combination)
• Safety management tolerance for sulfonylureas (notably hypoglycemia risk)

What constrains growth?

Key constraints typically include:

• Incretin uptake (GLP-1 and related agents) and SGLT2 market share gains
• Sulfonylurea adverse event burden in some patient segments
• Tighter managed-care criteria favoring newer classes where reimbursement permits

Market segmentation where Glucovance is most durable

Durability is generally strongest where:

• Generic dispensing dominates
• Payment systems favor oral, low-cost regimens
• Patient populations prioritize cost over class switching

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How will the Glucovance market perform over the next 5 years?

No quantitative projection can be produced from the information in scope for this request.

A credible 5-year projection requires at minimum:

• Current revenue or unit sales baseline by geography
• Share by oral diabetes combination subsegment
• Competitor pricing and formulary trajectory
• Evidence of pipeline or lifecycle drivers (new dosing strengths, pediatric indications, conversions)

Those inputs are not included in the request.

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Competitive landscape: where Glucovance competes

Glucovance competes primarily in oral combination and step-up oral therapy:

Direct substitutes

• Metformin + other sulfonylureas (fixed-dose combinations or separate dosing)
• Metformin + DPP-4 inhibitors
• Metformin + SGLT2 inhibitors (where preferred by payers)

Indirect substitutes

• Metformin monotherapy with add-on therapy
• GLP-1 and related agents (where reimbursement supports use)
• Insulin initiation in later-stage disease

Positioning reality

The product’s competitive wedge is usually price and simplicity. In formularies that encourage incretin or SGLT2 add-ons, Glucovance faces share pressure even if overall oral therapy use remains stable.

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Key Takeaways

• Glucovance is a fixed-dose metformin + glibenclamide (glyburide) combination for type 2 diabetes.
• A clinical trials update cannot be generated without current trial registry evidence (status, dates, and endpoints).
• A market projection cannot be generated without baseline market size, geography, and competitor/funding assumptions.
• Competitive pressure is structurally tied to incretin and SGLT2 adoption and payer formularies that favor newer oral classes or injectables.

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FAQs

1) What is Glucovance made of?
It is metformin hydrochloride combined with glibenclamide (glyburide).

2) What diabetes stage is Glucovance typically used for?
It is used as step-up oral combination therapy in type 2 diabetes when metformin alone is insufficient.

3) What class effects influence adoption?
Metformin drives cost and tolerability, while glibenclamide drives glucose lowering but adds hypoglycemia considerations.

4) What are Glucovance’s main substitutes?
Fixed-dose metformin + other oral agents (especially DPP-4 or SGLT2 combinations) and metformin with add-on therapy.

5) What determines near-term performance?
Formulary access, pricing pressure from newer classes, and local prescribing patterns.

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References

[1] No sources were provided in the prompt, and no registries or financial datasets were included to support a trials update or quantified market projection.