CLINICAL TRIALS PROFILE FOR GLYBURIDE AND METFORMIN HYDROCHLORIDE

All Clinical Trials for GLYBURIDE AND METFORMIN HYDROCHLORIDE

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.
NCT00194896 ↗	Preferred Treatment of Type 1.5 Diabetes	Completed	GlaxoSmithKline	N/A	2000-02-01	The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.
NCT00194896 ↗	Preferred Treatment of Type 1.5 Diabetes	Completed	Seattle Institute for Biomedical and Clinical Research	N/A	2000-02-01	The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.
NCT00194896 ↗	Preferred Treatment of Type 1.5 Diabetes	Completed	University of Washington	N/A	2000-02-01	The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.
NCT00232583 ↗	Preservation of Beta-cell Function in Type 2 Diabetes Mellitus	Completed	University of Texas Southwestern Medical Center	N/A	2003-11-01	The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.
NCT00279045 ↗	Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide	Completed	GlaxoSmithKline	Phase 3	2000-01-03	The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

Clinical Trial Conditions for GLYBURIDE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Healthy	5
Gestational Diabetes	5
Gestational Diabetes Mellitus	3
Type 2 Diabetes Mellitus	2

Condition MeSH

Condition MeSH for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus	16
Diabetes, Gestational	10
Diabetes Mellitus, Type 2	9
Hypertriglyceridemia	1

Clinical Trial Locations for GLYBURIDE AND METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Location	Trials
United States	117
United Kingdom	26
Canada	18
Germany	14
Italy	6

Trials by US State

Trials by US State for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Location	Trials
Texas	8
California	5
Pennsylvania	5
New York	5
Illinois	5

Clinical Trial Progress for GLYBURIDE AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	5
Phase 3	6

Clinical Trial Status

Clinical Trial Status for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	18
Unknown status	3
Terminated	3

Clinical Trial Sponsors for GLYBURIDE AND METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	5
Actavis Inc.	3
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for GLYBURIDE AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Other	23
Industry	15
U.S. Fed	1

GLYBURIDE AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: May 3, 2026

GLYBURIDE + METFORMIN HYDROCHLORIDE: Clinical Trial Status, Market Read-Through, and 2026-2031 Projection

What clinical trials are active or recently completed for glyburide + metformin hydrochloride?

No high-confidence, publicly indexable clinical trial set can be identified for the specific fixed-dose combination “glyburide and metformin hydrochloride” as a standalone investigational program across major registries in a way that supports a complete update (trial phase, timelines, endpoints, and readouts) for this exact combination.

For business planning purposes, the most reliable read-through is that the combination operates primarily as a marketed regimen rather than a currently sponsored, combination-specific development asset. In practice, recent “trial activity” in this therapeutic space tends to be driven by:

• New glucose-lowering agents combined with metformin
• Generic bioequivalence studies for combination products
• Comparators using metformin-based background therapy

What does the regulatory footprint imply for near-term development risk?

The glyburide-metformin combination has long-standing clinical use history in type 2 diabetes management, and the regimen’s positioning in therapy is established. That typically compresses the range of incremental clinical endpoints that sponsors pursue for new combination-specific programs. As a result, forward R&D value usually concentrates on:

• Dose optimization within the fixed-dose combination
• Safety surveillance and real-world effectiveness studies (often non-interventional)
• Formulation improvements (e.g., dissolution, adherence)

This profile reduces the probability of a near-term “registration-change” milestone driven by a new phase 3 efficacy program for the exact combination.

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Market analysis: Where does glyburide + metformin fit and what drives pricing and demand?

How big is the addressable market logic for this regimen?

The addressable market is the overlap of:

• Type 2 diabetes patients treated with metformin
• Patients requiring additional second-line therapy where sulfonylureas are a common option
• Patients in markets where fixed-dose combination products are available and reimbursed

The combination competes primarily against:

• Metformin + DPP-4 inhibitor (lower hypoglycemia risk)
• Metformin + SGLT2 inhibitor (cardio-renal outcome positioning)
• Metformin + GLP-1 receptor agonist (higher efficacy, route factors)
• Metformin + TZD or other oral add-ons

Sulfonylurea-based add-on remains relevant where:

• Cost sensitivity is high
• Insulin access or injection acceptance is limited
• Guideline algorithms allow sulfonylurea add-on after metformin

Pricing power and reimbursement profile

Glyburide (glybenclamide) plus metformin fixed-dose products usually sit in the “lower-cost oral” segment. That implies:

• Limited pricing power versus branded GLP-1, SGLT2, and DPP-4 classes
• Stable demand where payer policies favor low-cost combination oral therapy
• Higher use in formularies with tiered restrictions favoring metformin-based regimens

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Projection: 2026-2031 demand trajectory for glyburide + metformin

Base-case projection framework

Because the combination is established, the projection drivers are structural rather than pipeline-driven:

• Patient adherence to oral combination regimens
• Competitive displacement by newer non-sulfonylurea add-ons
• Payer tightening or expansion for low-cost therapies
• Segment shifts due to guideline emphasis on outcomes-based add-ons

Estimated market direction (directional)

• 2026-2027: modest decline risk from substitution toward SGLT2/GLP-1 where payer coverage supports it.
• 2028-2031: stabilization in cost-sensitive segments; continued erosion in commercially insured and outcome-driven formularies.
• Net outcome: a slow, structural decline rather than a breakaway growth profile.

Quantitative projection table (directional index)

No combination-specific global revenue time series can be produced with accuracy from the provided constraints. The table below is an index projection using a “base=100 in 2026” framework to inform planning.

Year	Demand index (base 2026 = 100)	Expected direction
2026	100	Baseline
2027	97	Mild displacement by newer add-ons
2028	95	Continued share erosion
2029	94	Stabilization in low-cost segment
2030	93	Gradual decline
2031	92	Low single-digit attrition continues

Business interpretation: Under this model, the combination does not produce major upside without a structural payer or formulary change.

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Commercial implications: what to watch next (operational KPIs)

What KPIs should anchor quarterly monitoring?

1. Formulary tier placement (oral non-insulin add-on segment) for metformin combinations
2. Claims mix by add-on class (sulfonylurea vs DPP-4 vs SGLT2 vs GLP-1)
3. Persistence for fixed-dose combinations (discontinuation rates within 6 and 12 months)
4. Hypoglycemia-related discontinuation signals (safety-driven switches away from sulfonylurea)

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Key Takeaways

• The glyburide + metformin hydrochloride combination is an established regimen, and a complete, combination-specific clinical trials update cannot be supported by publicly indexable evidence sufficient for a precise phase-by-phase tracker.
• Market dynamics are primarily substitution-driven rather than pipeline-driven, with sulfonylurea add-on facing ongoing competitive pressure from SGLT2 and GLP-1 classes where coverage supports them.
• A realistic 2026-2031 outlook is a low-single-digit annual demand attrition pattern, stabilizing in cost-sensitive segments rather than delivering sustained growth.
• Near-term business value focuses on access (formulary position), adherence/persistence metrics, and safety-driven discontinuation rather than new registration-grade efficacy milestones for the exact combination.

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FAQs

1) Is glyburide + metformin still used as a standard add-on to metformin?

Yes. Sulfonylurea add-on remains common in type 2 diabetes where cost and oral regimen adherence dominate treatment decisions.

2) What is the biggest commercial headwind for this fixed-dose combination?

Payer and guideline preference shifting toward newer add-ons with outcomes positioning and lower hypoglycemia risk, which displaces sulfonylurea-based combinations.

3) Does the combination have a likely near-term phase 3 catalyst?

A combination-specific, registration-grade phase 3 catalyst is not indicated by the absence of a supported, public trial development footprint for the exact combination in the available constraints.

4) What could reverse the projected demand trend?

A formulary or reimbursement shift that re-expands sulfonylurea-based low-cost oral combination coverage, or a major safety or persistence advantage via formulation or adherence programs.

5) How should investors value this asset class versus newer GLP-1/SGLT2 entrants?

As a volume/stability play in cost-sensitive segments with limited pricing power, rather than a high-growth innovation driver.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas (latest available edition as of 2024). Brussels: International Diabetes Federation.
[2] American Diabetes Association. Standards of Care in Diabetes. (Latest available edition). Diabetes Care.
[3] European Association for the Study of Diabetes. EASD/ADA Type 2 Diabetes treatment consensus report. (Latest available edition).