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Last Updated: April 24, 2025

CLINICAL TRIALS PROFILE FOR GLIPIZIDE; METFORMIN HYDROCHLORIDE


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All Clinical Trials for glipizide; metformin hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
NCT00660907 ↗ Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients Completed AstraZeneca 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.
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.
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
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for glipizide; metformin hydrochloride

Condition Name

4221000.511.522.533.54HealthyType 2 DiabetesType 2 Diabetes MellitusArterial Stiffness[disabled in preview]
Condition Name for glipizide; metformin hydrochloride
Intervention Trials
Healthy 4
Type 2 Diabetes 2
Type 2 Diabetes Mellitus 2
Arterial Stiffness 1
[disabled in preview] 0
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Condition MeSH

7611001234567Diabetes MellitusDiabetes Mellitus, Type 2HypertensionMyocardial Ischemia[disabled in preview]
Condition MeSH for glipizide; metformin hydrochloride
Intervention Trials
Diabetes Mellitus 7
Diabetes Mellitus, Type 2 6
Hypertension 1
Myocardial Ischemia 1
[disabled in preview] 0
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Clinical Trial Locations for glipizide; metformin hydrochloride

Trials by Country

+
Trials by Country for glipizide; metformin hydrochloride
Location Trials
United States 42
Israel 8
Hungary 8
India 7
Mexico 6
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Trials by US State

+
Trials by US State for glipizide; metformin hydrochloride
Location Trials
North Dakota 5
Minnesota 2
Massachusetts 2
Illinois 2
Arizona 1
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Clinical Trial Progress for glipizide; metformin hydrochloride

Clinical Trial Phase

27.3%18.2%45.5%9.1%011.522.533.544.55Phase 4Phase 3Phase 1[disabled in preview]
Clinical Trial Phase for glipizide; metformin hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 1 5
[disabled in preview] 1
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Clinical Trial Status

72.7%27.3%0012345678CompletedUnknown status[disabled in preview]
Clinical Trial Status for glipizide; metformin hydrochloride
Clinical Trial Phase Trials
Completed 8
Unknown status 3
[disabled in preview] 0
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Clinical Trial Sponsors for glipizide; metformin hydrochloride

Sponsor Name

trials000111112222Mylan PharmaceuticalsBristol-Myers SquibbTeva Pharmaceuticals USA[disabled in preview]
Sponsor Name for glipizide; metformin hydrochloride
Sponsor Trials
Mylan Pharmaceuticals 2
Bristol-Myers Squibb 2
Teva Pharmaceuticals USA 2
[disabled in preview] 2
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Sponsor Type

52.9%47.1%00123456789IndustryOther[disabled in preview]
Sponsor Type for glipizide; metformin hydrochloride
Sponsor Trials
Industry 9
Other 8
[disabled in preview] 0
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Glipizide and Metformin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Glipizide and Metformin Hydrochloride

Glipizide and metformin hydrochloride are oral hypoglycemic agents commonly used in the management of type 2 diabetes mellitus. These medications work synergistically to target insulin resistance and enhance glucose control, making them a crucial component in diabetes care.

Mechanism of Action

Metformin Hydrochloride

Metformin hydrochloride, a well-established drug for type 2 diabetes, has been found to exert its glucose-lowering effects primarily in the gut rather than in the bloodstream. This discovery, highlighted in a study published in Diabetes Care, indicates that metformin works largely in the lower intestine, reversing previous assumptions about its mechanism of action[1].

Glipizide

Glipizide is a sulfonylurea that stimulates the release of insulin from the pancreatic beta cells, thereby reducing blood glucose levels. When combined with metformin, it enhances the overall efficacy in controlling blood sugar levels[4].

Clinical Trials

Metformin Delayed Release (Metformin DR)

Recent clinical trials have focused on a delayed-release formulation of metformin (Metformin DR) to address the limitations of the current immediate-release and extended-release forms. In phase 1 and phase 2 trials, Metformin DR showed significant promise:

  • It reduced the amount of metformin in the blood by half compared to immediate-release and extended-release versions, making it safer for patients with impaired kidney function[1].
  • Metformin DR was found to be around 40% more potent than the extended-release version and demonstrated a sustained reduction in fasting plasma glucose over 12 weeks compared to placebo[1].

Combination Therapy with Glipizide

Clinical trials involving the combination of glipizide and metformin hydrochloride (e.g., Metaglip) have shown positive outcomes:

  • In a 24-week double-blind trial, Metaglip as initial therapy resulted in effective blood sugar control. However, it also highlighted the risk of hypoglycemia, particularly in the higher dosage groups[4].
  • The combination therapy was generally well-tolerated, with gastrointestinal symptoms such as diarrhea and nausea being common but comparable to those seen with metformin alone[4].

Market Analysis

Global Market Trends

The global market for metformin hydrochloride and glipizide tablets is expected to grow significantly due to several factors:

  • Increasing Prevalence of Diabetes: The rising global prevalence of type 2 diabetes, driven by aging populations, increasing obesity rates, and sedentary lifestyles, is a key driver of demand for these medications[2][5].
  • Market Size and Growth: The global market size 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 Markets

  • United States: The U.S. market is expected to see significant growth, driven by the increasing incidence of type 2 diabetes and the need for effective combination therapies.
  • China and Europe: These regions are also anticipated to experience growth, with China's market expected to expand due to its large population and increasing awareness of diabetes management[5].

Market Projections

Key Drivers

  • Growing Awareness and Adherence: Increased awareness about the importance of glycemic control and adherence to treatment regimens is driving the demand for these medications globally[2].
  • Product Segmentation and Company Strategies: Leading companies are focusing on enhancing their portfolios and capabilities, market entry strategies, and geographic expansion to capture a larger share of the growing market[5].

Challenges and Opportunities

  • Side Effects and Safety: While the combination therapy is generally well-tolerated, managing side effects such as hypoglycemia and gastrointestinal symptoms remains a challenge. Addressing these through innovative formulations and patient education could present opportunities for market growth[4].
  • Emerging Markets: The growing need for diabetes management in emerging economies offers significant opportunities for expansion and market penetration[5].

Key Takeaways

  • Mechanism of Action: Metformin's glucose-lowering effect primarily occurs in the gut, while glipizide stimulates insulin release from the pancreas.
  • Clinical Trials: Metformin DR and combination therapies with glipizide have shown promising results in clinical trials, offering safer and more effective treatment options.
  • Market Growth: The global market for metformin hydrochloride and glipizide tablets is expected to grow significantly, driven by increasing diabetes prevalence and improved treatment adherence.
  • Regional Expansion: The U.S., China, and Europe are key regions for market growth, with opportunities for expansion in emerging economies.

FAQs

Q1: What is the primary mechanism of action of metformin hydrochloride in treating type 2 diabetes?

A1: Metformin hydrochloride primarily exerts its glucose-lowering effects in the gut, rather than in the bloodstream[1].

Q2: What are the common side effects of the combination therapy of glipizide and metformin hydrochloride?

A2: Common side effects include hypoglycemia, diarrhea, nausea/vomiting, and abdominal pain[4].

Q3: How does the delayed-release formulation of metformin (Metformin DR) differ from the current formulations?

A3: Metformin DR reduces the amount of metformin in the blood, making it safer for patients with impaired kidney function and more potent than extended-release versions[1].

Q4: What are the key drivers of the growing market for metformin hydrochloride and glipizide tablets?

A4: The growing prevalence of type 2 diabetes, increasing awareness of glycemic control, and improved treatment adherence are key drivers[2][5].

Q5: Which regions are expected to see significant growth in the market for metformin hydrochloride and glipizide tablets?

A5: The United States, China, and Europe are anticipated to experience significant growth, with emerging economies also presenting opportunities for expansion[5].

Sources

  1. Medical News Today: "New metformin may help more patients with type 2 diabetes"
  2. 360iResearch: "Metformin Hydrochloride & Glipizide Tablets Market 2025-2030"
  3. TGA: "Extract from the Clinical Evaluation Report for Saxagliptin / metformin"
  4. RxList: "Metaglip (Glipizide and Metformin): Side Effects, Uses"
  5. LP Information Data: "Global Metformin Hydrochloride and Glipizide Tablets Market"

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