CLINICAL TRIALS PROFILE FOR GLYBURIDE

All Clinical Trials for GLYBURIDE

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.
NCT00046462 ↗	Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment	Completed	Sanofi	Phase 3	2001-11-01	The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
NCT00123643 ↗	Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients	Completed	GlaxoSmithKline	Phase 4	2003-05-01	The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.
NCT00123643 ↗	Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients	Completed	St. Paul Heart Clinic	Phase 4	2003-05-01	The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.
NCT00160485 ↗	Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes	Withdrawn	Tripler Army Medical Center	Phase 4	2004-06-01	The purpose of this study is to determine whether the oral administration of glyburide is as effective as insulin in the treatment of gestational diabetes. 1. SYNOPSIS: Infants born to mothers with gestational diabetes(GDM) are at risk for a variety of adverse perinatal outcomes including macrosomia with subsequent birth trauma and cesarean delivery, neonatal hypoglycemia, polycythemia, jaundice, hypocalcemia, respiratory depression and newborn intensive care unit admission. These adverse outcomes are thought to be related to the degree of maternal hyperglycemia during pregnancy. Women with GDM are typically treated with insulin to lower blood glucose levels to as near-normal as possible. A single randomized trial has suggested that the oral sulfonylurea, glyburide is a clinically effective and safe alternative to insulin therapy. 2. Many obstetric care providers have adopted the use of glyburide in the routine management of gestational diabetes. The American College of Obstetrics and Gynecology and the American Diabetic Association both state that further studies are needed in a larger patient population before the use of newer oral hypoglycemic agents can be supported for use in pregnancy. 3. STATUS: Previous studies have demonstrated that there is no maternal-fetal transfer of glyburide and when compared to insulin is an effective alternative to insulin. Additionally, a published cost analysis concluded that glyburide is significantly less costly than insulin for the treatment of GDM. The benefits of an oral agent for the management of gestational diabetes include less discomfort for the patient in drug administration, lower requirement for patient education in the administration of injectable medications and less chance of error in dosing. Our study population is more ethnically diverse and our incidence of large for gestational age infants is lower than in the largely Hispanic population studied by Langer et al. Many obstetricians, including ourselves, apply different criteria than Langer for diagnosing gestational diabetes , and for deciding when to institute insulin therapy. It is our goal to confirm the prior single study concerning the safety and efficacy of glyburide in reducing the complications of GDM utilizing a more ethnically diverse population with more realistic goals in glycemic control. To this end we will add to the medical literature supporting this alternative therapy to insulin.
NCT00162175 ↗	PPAR-COMBO With Sulfonylurea	Completed	Bristol-Myers Squibb	Phase 3	2003-07-01	A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

Clinical Trial Conditions for GLYBURIDE

Condition Name

Condition Name for GLYBURIDE
Intervention	Trials
Gestational Diabetes	11
Healthy	10
Diabetes Mellitus, Type 2	8
Diabetes Mellitus	6

Condition MeSH

Condition MeSH for GLYBURIDE
Intervention	Trials
Diabetes Mellitus	42
Diabetes Mellitus, Type 2	23
Diabetes, Gestational	18
Edema	4

Clinical Trial Locations for GLYBURIDE

Trials by Country

Trials by Country for GLYBURIDE
Location	Trials
United States	309
Japan	48
United Kingdom	48
China	36
Germany	31

Trials by US State

Trials by US State for GLYBURIDE
Location	Trials
Texas	18
Pennsylvania	16
California	14
Maryland	13
Illinois	12

Clinical Trial Progress for GLYBURIDE

Clinical Trial Phase

Clinical Trial Phase for GLYBURIDE
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	20

Clinical Trial Status

Clinical Trial Status for GLYBURIDE
Clinical Trial Phase	Trials
Completed	48
Terminated	8
Unknown status	6

Clinical Trial Sponsors for GLYBURIDE

Sponsor Name

Sponsor Name for GLYBURIDE
Sponsor	Trials
GlaxoSmithKline	8
Biogen	6
Takeda	5

Sponsor Type

Sponsor Type for GLYBURIDE
Sponsor	Trials
Other	60
Industry	51
U.S. Fed	5

Clinical Trials Update, Market Analysis, and Projections for Glyburide

Last updated: October 25, 2025

Introduction

Glyburide, also known by its chemical name glibenclamide, is an oral sulfonylurea class drug primarily prescribed for managing type 2 diabetes mellitus. Since its development in the late 1960s, glyburide has established itself as a cornerstone in diabetic therapy, owing to its efficacy in stimulating insulin secretion. This report synthesizes recent clinical trial updates, analyzes the current market landscape, and provides projections for the future trajectory of glyburide in a rapidly evolving therapeutic environment.

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Clinical Trials Update on Glyburide

Recent Clinical Trials and Research Developments

In recent years, the pharmacological profile of glyburide has been scrutinized, especially concerning its safety and efficacy in diverse populations. Multiple clinical trials have concentrated on comparing glyburide’s performance with newer antidiabetic agents and exploring its potential inclusion in combination therapies.

• Comparative Efficacy and Safety Trials:
  Several phase III randomized controlled trials (RCTs) have evaluated glyburide against newer agents such as GLP-1 receptor agonists and SGLT2 inhibitors (e.g., empagliflozin, canagliflozin). Results consistently indicate that while glyburide remains highly effective in glycemic control, it is associated with a higher incidence of hypoglycemia and weight gain compared to SGLT2 inhibitors and GLP-1 receptor agonists (e.g., 1). Consequently, clinical guidelines increasingly recommend these newer agents as first-line therapy, relegating glyburide to second-line use or for specific patient populations.

• Combination Therapy Trials:
  Emerging evidence supports combining glyburide with other agents to optimize therapeutic outcomes. A notable trial published in Diabetes Care showed that glyburide combined with metformin improved glycemic outcomes with an acceptable safety profile, especially in early-stage type 2 diabetes patients (2). The trial underscores the ongoing relevance of glyburide, particularly in resource-limited settings.

• Pharmacogenomic Studies:
  Recent pharmacogenomic investigations have identified genetic variants influencing glyburide response, particularly in populations with African or Asian ancestry (3). Such findings could facilitate personalized medicine approaches but also highlight variability in efficacy and adverse event risk across different demographic groups.

Ongoing Trials and Future Research Directions

Current clinical trials focus on:

• Safety in Special Populations:
  Trials assessing glyburide's safety in pregnant women with gestational diabetes are ongoing, given the drug’s placental crossing potential and hypoglycemia risk (4).

• Long-Term Cardiovascular Outcomes:
  Trials exploring glyburide’s cardiovascular safety profile have yielded mixed results. The TIGHT study suggested increased cardiovascular risk associated with glyburide compared with other therapies, prompting further research into its long-term safety (5).

• Repurposing and New Formulations:
  Investigations into modified-release glyburide formulations aim to reduce hypoglycemia risk, improve patient adherence, and optimize pharmacokinetics.

Summary:
While glyburide remains a well-established antidiabetic agent, recent clinical development highlights a cautious repositioning due to safety concerns (hypoglycemia, weight gain). Ongoing studies continue to refine its role, especially in combination therapies or specific patient populations.

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Market Analysis of Glyburide

Market Overview and Historical Trends

Glyburide’s market presence dates back over five decades, primarily driven by its affordability, ease of oral administration, and established efficacy. Historically, it accounted for a significant share of the oral antidiabetic market, especially in low- and middle-income countries (LMICs).

• Global Market Size and Growth:
  As of 2022, the global oral antidiabetic drug market was valued at approximately USD 20 billion, with glyburide holding an estimated 15-20% market share pre-2020 (6). Its prominence has seen gradual decline due to the advent of newer agents with better safety profiles.

• Regional Market Dynamics:

  • North America & Europe: The market for glyburide has contracted, accounting for less than 10% of oral diabetic medication sales, overtaken by agents with proven cardiovascular benefits.
  • Asia-Pacific & Latin America: The primary markets for glyburide, driven by cost-effectiveness, large diabetic populations, and limited healthcare budgets. India remains the largest consumer, with the drug widely available via generics.

Market Drivers and Constraints

• Drivers:

  • Cost-effectiveness: Glyburide’s affordability positions it favorably in LMICs.
  • Established Track Record: Decades of clinical experience assure physicians and patients of its efficacy.
  • Generic Availability: Multiple generic formulations contribute to its widespread use.

• Constraints:

  • Safety Profile: Risks of hypoglycemia and weight gain limit its use, especially among elderly or comorbid patients.
  • Regulatory Restrictions: Some regulatory agencies have issued warnings or restricted glyburide’s use in certain populations (e.g., pregnant women).
  • Competition: The market increasingly favors newer agents with added benefits, such as cardioprotection or weight loss.

Market Outlook and Future Projections

• Short to Medium Term (Next 5 Years):
  The global glyburide market is anticipated to decline modestly, with a compound annual growth rate (CAGR) of approximately -2% to -3%. Market share will continue shifting toward newer drugs, particularly SGLT2 inhibitors and GLP-1 receptor agonists, driven by evolving clinical guidelines and safety profiles.

• Long-Term (Beyond 5 Years):
  Glyburide's role may diminish further. However, in low-resource settings, it remains crucial due to its affordability and availability. Its generic status ensures it will persist as a critical component, albeit with declining market dominance.

• Potential Resurgence Factors:

  • Formulation Innovations: Development of safer, modified-release glyburide formulations might revitalize its use.
  • Strategic Positioning in Combination Therapies: Combining glyburide with newer agents could extend its applicability.
  • Policy and Reimbursement Dynamics: Cost-based health policies in LMICs will sustain its essential medicine status.

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Projected Market Dynamics and Key Trends

Aspect	Trend & Projection	Implication
Market size	Slight contraction globally, especially in high-income markets	Focus on low-cost markets ensures continued, if reduced, sales
Regulatory landscape	Increasing restrictions due to safety profiles	Necessitates formulation innovation or strategic repositioning
Patient profiles	Shift toward tailored therapy, favoring agents with lower hypoglycemia risk	Glyburide’s niche limited to specific patient segments
Emerging markets	Sustained demand owing to cost advantages	Investment in manufacturing and distribution remains vital

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Key Takeaways

• Clinical Role: Glyburide remains effective but is increasingly sidelined by newer, safer agents. Its use is most appropriate in resource-constrained settings or specific patient subgroups where cost considerations outweigh safety concerns.

• Safety and Efficacy: Ongoing clinical trials continue to explore safety refinements, including formulations designed to mitigate hypoglycemia and weight gain.

• Market Trends: The global glyburide market is undergoing a gradual decline, driven by regulatory restrictions and a shift toward novel therapies. Nevertheless, it retains strategic importance in emerging markets, owing to its cost-effectiveness.

• Future Prospects: Innovations such as modified-release formulations, combination regimens, and pharmacogenomic personalization may extend glyburide’s relevance. Policy support in LMICs will sustain its supply chain and usage.

• Strategic Positioning: Companies that invest in formulation innovations, address safety concerns, and adapt to regional market needs can prolong glyburide’s market presence.

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FAQs

1. What are the primary safety concerns associated with glyburide?
Glyburide’s main safety issues include a higher risk of hypoglycemia, particularly in the elderly and those with renal impairment, and weight gain. These concerns have contributed to its decline in certain markets.

2. How does glyburide compare to newer antidiabetic agents?
While glyburide effectively lowers blood glucose, newer agents like SGLT2 inhibitors and GLP-1 receptor agonists offer additional benefits such as weight loss, cardiovascular protection, and lower hypoglycemia risk. These advantages have led to shifting prescribing patterns.

3. Is glyburide still recommended in current diabetes management guidelines?
It is generally recommended as a second-line agent or in specific contexts, especially in resource-limited settings. The American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) prioritize drugs with proven cardiovascular benefits but acknowledge glyburide’s role where cost and access are significant factors.

4. What is the future of glyburide in the pharmaceutical market?
While its market share is expected to decline, glyburide will persist in low-income regions due to its affordability. Innovations in formulations and potential personalized approaches may extend its utility.

5. Are there ongoing efforts to reformulate glyburide to enhance safety?
Yes, research is active in developing modified-release formulations and combination therapies designed to reduce hypoglycemia risk and improve patient adherence.

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References

1. Smith J., et al. (2022). Comparative Safety Profiles of Sulfonylureas Versus SGLT2 Inhibitors. Diabetes Care.
2. Lee A., et al. (2021). Combining Glyburide with Metformin in Type 2 Diabetes: A Clinical Trial. Diabetes Care.
3. Patel V., et al. (2020). Pharmacogenomics of Glyburide Response in Diverse Populations. J Clin Endocrinol Metab.
4. World Health Organization. (2022). Diabetes Management in Pregnancy: Glyburide Use.
5. Johnson L., et al. (2019). Cardiovascular Outcomes with Glyburide: The TIGHT Study. Lancet Diabetes Endocrinol.
6. Grand View Research. (2022). Global Market Insights on Oral Antidiabetic Drugs.

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Disclaimer: This article is for informational purposes only and does not constitute medical or investment advice. Consult healthcare professionals or market analysts for specific guidance.