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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR GLIPIZIDE AND METFORMIN HYDROCHLORIDE


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All Clinical Trials for Glipizide And Metformin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00513630 ↗ Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease Completed Shanghai Jiao Tong University School of Medicine Phase 4 2004-06-01 The purpose of this study is to explore the recurrence risk of cardiovascular events in patients with type 2 diabetes mellitus and coronary heart disease after different antidiabetic drug therapy (glipizide or metformin) by using an double-blind, randomized, parallel control and prospective study The end point of this study is: 1. follow up 3yr 2. recurrence of cardiovascular event 3. death caused by other reasons such as stroke, uremia, blindness and amputation
NCT00648505 ↗ Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg Completed Mylan Pharmaceuticals Phase 1 2005-06-01 The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fed conditions.
NCT00649454 ↗ Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg Completed Mylan Pharmaceuticals Phase 1 2005-06-01 The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5 mg/500 mg) dose administration under fasting conditions.
NCT00660907 ↗ Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients Completed Bristol-Myers Squibb Phase 3 2008-03-01 This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glipizide And Metformin Hydrochloride

Condition Name

Condition Name for Glipizide And Metformin Hydrochloride
Intervention Trials
Healthy 4
Type 2 Diabetes 2
Type 2 Diabetes Mellitus 2
Arterial Stiffness 1
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Condition MeSH

Condition MeSH for Glipizide And Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 7
Diabetes Mellitus, Type 2 6
Myocardial Ischemia 1
Coronary Disease 1
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Clinical Trial Locations for Glipizide And Metformin Hydrochloride

Trials by Country

Trials by Country for Glipizide And Metformin Hydrochloride
Location Trials
United States 42
Hungary 8
Israel 8
India 7
Mexico 6
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Trials by US State

Trials by US State for Glipizide And Metformin Hydrochloride
Location Trials
North Dakota 5
Massachusetts 2
Illinois 2
Minnesota 2
New Mexico 1
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Clinical Trial Progress for Glipizide And Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Glipizide And Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for Glipizide And Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 8
Unknown status 3
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Clinical Trial Sponsors for Glipizide And Metformin Hydrochloride

Sponsor Name

Sponsor Name for Glipizide And Metformin Hydrochloride
Sponsor Trials
Teva Pharmaceuticals USA 2
Mylan Pharmaceuticals 2
Bristol-Myers Squibb 2
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Sponsor Type

Sponsor Type for Glipizide And Metformin Hydrochloride
Sponsor Trials
Industry 9
Other 8
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Glipizide and Metformin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Glipizide and metformin hydrochloride is a combination medication widely used to manage type 2 diabetes mellitus (T2DM). This article delves into the current clinical trials, market analysis, and future projections for this essential antidiabetic drug combination.

Clinical Trials and Efficacy

Current Clinical Landscape

The combination of glipizide and metformin has been well-established in the treatment of T2DM. Clinical trials have consistently shown the efficacy of this combination in improving glycemic control. For instance, studies have demonstrated that glipizide stimulates the release of insulin from the pancreas, while metformin slows the absorption of sugar in the small intestine, stops the liver from converting stored sugar into blood sugar, and enhances the body's use of natural insulin[4].

Ongoing and Future Trials

While there are no new clinical trials specifically focused on glipizide and metformin hydrochloride as a combination, ongoing research in antidiabetic agents often includes these drugs as comparators or in combination with newer agents. For example, trials involving newer classes of drugs like SGLT2 inhibitors and GLP-1 receptor agonists often include metformin as a standard treatment arm[1].

Mechanism of Action

The dual action of glipizide and metformin makes this combination highly effective. Glipizide, a sulfonylurea, stimulates insulin release from the pancreas. Metformin, a biguanide, works by inhibiting mitochondrial isoform of glycerophosphate dehydrogenase, indirectly activating AMPK, and reducing liver gluconeogenesis and hepatic glucose secretion[1].

Market Analysis

Global Market Size and Growth

The global market for metformin hydrochloride and glipizide tablets is projected to grow from US$ 115 million in 2024 to US$ 144 million by 2030, at a Compound Annual Growth Rate (CAGR) of 3.8%[5].

Regional Market Trends

  • United States: The market in the U.S. is expected to see significant growth, driven by increasing awareness about diabetes management and the necessity of glycemic control.
  • China and Europe: These regions are also anticipated to experience growth, with China's market driven by a large and growing diabetic population, and Europe's market influenced by stringent healthcare regulations and high standards of care[5].

Key Drivers

The growing prevalence of diabetes worldwide, fueled by factors such as aging populations, rising obesity rates, and sedentary lifestyles, is a major driver for the demand of these medications. Increased awareness about diabetes prevention and the importance of glycemic control further supports market growth[2].

Market Segmentation

By Type

The market is segmented into original drugs and generic drugs. Generic versions of glipizide and metformin hydrochloride are becoming increasingly popular, especially in developing economies, due to their lower cost[5].

By Application

The primary applications include hospitals, clinics, retail pharmacies, and online pharmacies. The ease of availability through various channels contributes to the market's expansion[2].

Key Players

Several pharmaceutical companies are prominent in the market for metformin hydrochloride and glipizide tablets. These include:

  • Teva Pharmaceuticals
  • Viatris
  • YANGTZE River Pharmaceutical Group
  • Jiangsu Zilong Pharmaceutical
  • Hefei Lifeon Pharmaceutical

These companies are focused on expanding their product portfolios and market penetration, which is expected to drive further growth in the sector[5].

Market Projections

Forecast by Region

The market is forecasted to grow across various regions, with the Americas, APAC, and Europe being key contributors. The APAC region, particularly China, is expected to show significant growth due to the large diabetic population and increasing healthcare expenditure[5].

Emerging Opportunities

The growing need for personalized and accessible treatments for T2DM presents opportunities for innovation. The integration of newer antidiabetic agents with traditional treatments like glipizide and metformin could lead to more effective and tailored treatment regimens[1].

Regulatory Environment

The FDA and other regulatory bodies play a crucial role in approving and monitoring the use of these medications. For instance, the FDA has approved several combination regimens, including glyburide/metformin and glipizide/metformin, which are widely used in clinical practice[1][4].

Conclusion

Glipizide and metformin hydrochloride remain a cornerstone in the management of type 2 diabetes mellitus. With ongoing clinical trials and market growth driven by increasing demand, this combination is set to continue its dominance in the antidiabetic drug market.

Key Takeaways

  • Clinical Efficacy: The combination of glipizide and metformin is highly effective in managing T2DM through dual mechanisms of action.
  • Market Growth: The global market is projected to grow at a CAGR of 3.8% from 2024 to 2030.
  • Regional Trends: Significant growth is expected in the U.S., China, and Europe.
  • Key Drivers: Increasing diabetes prevalence, awareness about glycemic control, and the availability of generic versions.
  • Market Segmentation: Original and generic drugs, with applications in hospitals, clinics, and pharmacies.

FAQs

Q: What is the primary mechanism of action of glipizide and metformin hydrochloride?

A: Glipizide stimulates insulin release from the pancreas, while metformin slows sugar absorption, stops liver conversion of stored sugar, and enhances natural insulin use[4].

Q: What is the projected global market size for metformin hydrochloride and glipizide tablets by 2030?

A: The global market is projected to grow to US$ 144 million by 2030[5].

Q: Which regions are expected to drive market growth for these medications?

A: The United States, China, and Europe are expected to be key drivers of market growth[5].

Q: What are the main drivers of the market for glipizide and metformin hydrochloride?

A: The main drivers include the growing prevalence of diabetes, increasing awareness about glycemic control, and the availability of generic versions[2].

Q: Who are some of the key players in the market for these medications?

A: Key players include Teva Pharmaceuticals, Viatris, YANGTZE River Pharmaceutical Group, Jiangsu Zilong Pharmaceutical, and Hefei Lifeon Pharmaceutical[5].

Sources

  1. Frontiers in Pharmacology: Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New Combinations, and Alternatives in Clinical Trials.
  2. 360 Research Reports: Metformin Hydrochloride & Glipizide Tablets Market 2025-2030.
  3. FDA: Clinical Review of Dapagliflozin.
  4. Mayo Clinic: Glipizide and Metformin (oral route).
  5. LP Information Data: Global Metformin Hydrochloride and Glipizide Tablets Market.
Last updated: 2025-01-01

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