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Last Updated: January 15, 2025

CLINICAL TRIALS PROFILE FOR GLUCOVANCE


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Glucovance
Intervention Trials
Diabetes Mellitus 3
Diabetes, Gestational 2
Diabetes Mellitus, Type 2 2
Kidney Diseases 1
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Clinical Trial Locations for Glucovance

Trials by Country

Trials by Country for Glucovance
Location Trials
United States 35
Canada 2
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Trials by US State

Trials by US State for Glucovance
Location Trials
Texas 3
Illinois 2
California 2
Tennessee 2
New York 2
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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
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for Glucovance
Sponsor Trials
Bristol-Myers Squibb 2
Teva Pharmaceuticals USA 2
Regional Obstetrical Consultants 1
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Sponsor Type

Sponsor Type for Glucovance
Sponsor Trials
Industry 5
Other 3
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GLUCOVANCE: Clinical Trials, Market Analysis, and Projections

Introduction to GLUCOVANCE

GLUCOVANCE is a combination medication consisting of glyburide and metformin, used to manage type 2 diabetes. It combines the sulfonylurea glyburide, which stimulates insulin release, and the biguanide metformin, which reduces glucose production in the liver and enhances insulin sensitivity.

Clinical Trials Overview

In clinical trials, GLUCOVANCE has been evaluated for its efficacy and safety as both initial and second-line therapy for type 2 diabetes.

Efficacy

  • In double-blind clinical trials, GLUCOVANCE was compared to metformin, glyburide, and placebo. These trials involved a total of 642 patients receiving GLUCOVANCE, with results showing that GLUCOVANCE effectively reduced fasting plasma glucose (FPG), postprandial glucose (PPG), and hemoglobin A1c (HbA1c) levels[1].

Safety and Adverse Events

  • The most common adverse events reported in these trials included hypoglycemic symptoms, which occurred in approximately 30% to 35% of patients when GLUCOVANCE was used as initial therapy. When used as second-line therapy, the frequency of hypoglycemic symptoms was lower, at around 6.8%[1].
  • The addition of thiazolidinediones to GLUCOVANCE therapy also increased the incidence of hypoglycemia, with 22% of patients reporting fingerstick glucose measurements ≤ 50 mg/dL compared to 3.3% of placebo-treated patients[1].

Market Analysis

Current Market Position

  • GLUCOVANCE, while effective, is part of a broader market for type 2 diabetes treatments that is increasingly dominated by newer classes of drugs such as GLP-1 receptor agonists and SGLT2 inhibitors.
  • The market for type 2 diabetes treatments is highly competitive, with multiple therapeutic options available, each with its own advantages and disadvantages.

Market Trends

  • The global diabetes market is growing, driven by increasing prevalence of type 2 diabetes and the need for effective management options. However, GLUCOVANCE, being an older combination therapy, may face challenges in maintaining market share against newer, more innovative treatments.
  • The rise of GLP-1 receptor agonists, such as Novo Nordisk’s Ozempic and Eli Lilly’s tirzepatide, is expected to significantly impact the market. These drugs are projected to reach combined sales of about $50 billion by 2025, indicating a shift towards more modern therapeutic approaches[5].

Projections and Future Outlook

Sales Projections

  • Given the competitive landscape and the emergence of newer therapies, the sales projections for GLUCOVANCE are likely to be modest. While it will continue to be used, especially in regions where access to newer drugs is limited, its market share is expected to decline.
  • There are no recent specific sales projections available for GLUCOVANCE alone, but the overall trend suggests that older combination therapies like GLUCOVANCE will see reduced market presence as newer drugs gain traction.

Clinical Relevance

  • Despite the rise of newer treatments, GLUCOVANCE remains a viable option for many patients, particularly those who cannot afford or access the newer, more expensive therapies. Its efficacy and safety profile, established through extensive clinical trials, ensure it will continue to be prescribed in certain clinical scenarios.

Key Considerations for Healthcare Providers

Monitoring and Dose Titration

  • Healthcare providers should continue to monitor blood glucose levels and adjust the dose of GLUCOVANCE as necessary to achieve optimal glycemic control. Regular HbA1c measurements are crucial to assess the effectiveness of therapy[1].

Patient Education

  • Educating patients on the proper use of GLUCOVANCE, including the risk of hypoglycemia and the importance of regular monitoring, is essential for effective management of type 2 diabetes.

Conclusion

GLUCOVANCE remains a valuable treatment option for type 2 diabetes, despite the evolving landscape of diabetes therapies. Its established efficacy and safety profile make it a reliable choice, especially in settings where access to newer drugs is limited. However, its market share is likely to be impacted by the growing popularity of newer classes of drugs.

Key Takeaways

  • Efficacy: GLUCOVANCE effectively reduces FPG, PPG, and HbA1c levels.
  • Safety: Common adverse events include hypoglycemic symptoms, especially when combined with other therapies.
  • Market Trends: The rise of GLP-1 receptor agonists and other newer therapies is expected to impact GLUCOVANCE’s market share.
  • Clinical Relevance: GLUCOVANCE remains a viable option, particularly in regions with limited access to newer drugs.
  • Monitoring: Regular blood glucose and HbA1c monitoring are crucial for optimal glycemic control.

FAQs

Q: What is GLUCOVANCE used for?

A: GLUCOVANCE is used to manage type 2 diabetes by combining glyburide and metformin to reduce blood glucose levels.

Q: What are the common adverse events associated with GLUCOVANCE?

A: The most common adverse events include hypoglycemic symptoms, which can occur more frequently when GLUCOVANCE is combined with other therapies like thiazolidinediones.

Q: How does GLUCOVANCE compare to newer diabetes treatments?

A: GLUCOVANCE is an older combination therapy that, while effective, faces competition from newer classes of drugs such as GLP-1 receptor agonists, which are expected to dominate the market in the coming years.

Q: What is the recommended monitoring schedule for patients on GLUCOVANCE?

A: Patients should have their blood glucose levels monitored regularly, and HbA1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy.

Q: Is GLUCOVANCE still a viable treatment option?

A: Yes, GLUCOVANCE remains a viable option, especially in settings where access to newer, more expensive therapies is limited.

Sources

  1. RxList: Glucovance (Glyburide and Metformin): Side Effects, Uses ...
  2. Business Wire: Global Glucosamine Market Analysis, Trends & Industry Forecast to 2025
  3. CarelonRx: Drug and biologic pipeline update Q3 2023
  4. Pfizer: Pfizer Provides Update on GLP-1-RA Clinical Development Program
  5. BioCentury: Leading GLP-1s expected to reach $50B in 2025 sales

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