CLINICAL TRIALS PROFILE FOR GLUMETZA

All Clinical Trials for glumetza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	National Eye Institute (NEI)	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	SmithKline Beecham	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	VA Office of Research and Development	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00087516 ↗	Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-06-01	The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
NCT00443755 ↗	Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance	Completed	National Center for Research Resources (NCRR)	Phase 2	2005-08-01	The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
NCT00443755 ↗	Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2005-08-01	The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.
NCT00443755 ↗	Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance	Completed	Takeda Pharmaceuticals North America, Inc.	Phase 2	2005-08-01	The objective of this study is to determine whether targeted pharmacological improvement of insulin sensitivity will normalize the associated elevations of thrombotic and inflammatory cardiovascular disease (CVD) biomarkers in individuals with insulin resistance.

Clinical Trial Conditions for glumetza

Condition Name

Condition Name for glumetza
Intervention	Trials
Type 2 Diabetes Mellitus	6
Type 2 Diabetes	5
Healthy	5
Insulin Resistance	5

Condition MeSH

Condition MeSH for glumetza
Intervention	Trials
Diabetes Mellitus	14
Diabetes Mellitus, Type 2	11
Insulin Resistance	6
Colorectal Neoplasms	3

Clinical Trial Locations for glumetza

Trials by Country

Trials by Country for glumetza
Location	Trials
United States	144
China	17
Canada	7
Mexico	4
South Africa	4

Trials by US State

Trials by US State for glumetza
Location	Trials
Arizona	9
California	8
Colorado	7
North Carolina	7
New York	7

Clinical Trial Progress for glumetza

Clinical Trial Phase

Clinical Trial Phase for glumetza
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for glumetza
Clinical Trial Phase	Trials
Completed	26
Recruiting	8
Terminated	6

Clinical Trial Sponsors for glumetza

Sponsor Name

Sponsor Name for glumetza
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	5
National Cancer Institute (NCI)	5
Janssen Research & Development, LLC	5

Sponsor Type

Sponsor Type for glumetza
Sponsor	Trials
Other	42
Industry	28
NIH	20

Glumetza Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for GLUMETZA

Introduction

GLUMETZA, a brand name for metformin hydrochloride extended-release tablets, is a crucial medication in the management of type 2 diabetes mellitus. This article delves into the clinical trials, market analysis, and future projections for GLUMETZA, providing a comprehensive overview of its significance and market dynamics.

Clinical Trials Overview

Efficacy and Safety

GLUMETZA has been extensively studied in various clinical trials to evaluate its efficacy and safety. In a multicenter, randomized, double-blind, active-controlled study, GLUMETZA was compared to immediate-release metformin. The study involved newly diagnosed patients, as well as those who had received previous treatment with diet and exercise, sulfonylureas, or other antihyperglycemic agents. The results showed that GLUMETZA regimens were at least as effective as immediate-release metformin in all measures of glycemic control, including HbA1c levels, fasting plasma glucose, and body weight[1].

Combination Therapy

GLUMETZA has also been evaluated in combination with other antidiabetic medications, such as sulfonylureas. In a study where GLUMETZA was combined with glyburide, the results indicated that the combination therapy was statistically significant in reducing HbA1c levels compared to glyburide alone. This combination was well-tolerated and effective in improving glycemic control[1].

Pharmacokinetics

Clinical trials have also examined the pharmacokinetics of GLUMETZA. Single oral doses of GLUMETZA from 500 mg to 2500 mg resulted in less than proportional increases in both the area under the concentration-time curve (AUC) and the maximum concentration (Cmax). This suggests that the drug's absorption and metabolism are not linear across the dose range[1].

Market Analysis

Market Size and Growth

The metformin hydrochloride tablets market, which includes GLUMETZA, is anticipated to experience significant growth due to several key factors. The rising prevalence of type 2 diabetes, coupled with an increasing geriatric population, is driving the demand for metformin hydrochloride tablets. North America is expected to dominate this market, followed by Europe, due to the high incidence of type 2 diabetes and the growing elderly population[2].

Geographical Segmentation

Geographically, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to lead the market due to the high demand for the drug, while Asia Pacific is projected to register the highest compound annual growth rate (CAGR) due to its growing healthcare sector and large target population[2].

Key Market Drivers and Restraints

The key drivers of the metformin hydrochloride tablets market include the increasing prevalence of type 2 diabetes and the growing geriatric population. However, side effects associated with the drug, such as gastrointestinal issues, are a significant restraint to market growth[2].

Market Projections

Future Growth

The metformin hydrochloride tablets market is expected to continue growing, driven by the increasing patient pool of type 2 diabetes and the launch of new products by key market players. Generic versions of GLUMETZA, such as those launched by Teva Pharmaceutical Industries Ltd., are also expected to contribute to market growth[2].

Competitive Landscape

The market for GLUMETZA and other metformin hydrochloride tablets is competitive, with several key players operating in the space. The launch of generic versions and the presence of established brands will continue to shape the market landscape. The competitive market share is influenced by factors such as price, dose frequency, safety profile, and efficacy[2].

Comparison with Other Antidiabetic Medications

GLP-1 Receptor Agonists

In contrast to GLUMETZA, GLP-1 receptor agonists, such as dulaglutide (Trulicity) and semaglutide (Ozempic), are gaining traction due to their high efficacy in glycemic control, weight loss, and cardiovascular benefits. The GLP-1 receptor agonist market is projected to grow at a CAGR of 17.46% from 2025 to 2030, driven by the launch of new products and a strong product pipeline for both diabetes and obesity applications[3].

Regulatory and Patent Considerations

Regulatory Approvals

GLUMETZA has received regulatory approvals for its use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug's regulatory status and any future approvals will be crucial in determining its market position[1].

Patent Law and NPV Models

The value of GLUMETZA is also evaluated through net present value (NPV) models, which consider factors such as patent law, regulatory approval processes, and cash flows. These models help in understanding the drug's potential success rates and financial viability[4].

Key Takeaways

• Clinical Efficacy: GLUMETZA has been shown to be effective in improving glycemic control when used as monotherapy or in combination with other antidiabetic medications.
• Market Growth: The metformin hydrochloride tablets market, including GLUMETZA, is expected to grow significantly due to the rising prevalence of type 2 diabetes and an increasing geriatric population.
• Geographical Dominance: North America is expected to dominate the market, while Asia Pacific is projected to register the highest CAGR.
• Competitive Landscape: The market is competitive, with generic versions and established brands influencing market share.
• Regulatory and Patent Considerations: Regulatory approvals and patent law play crucial roles in determining the drug's market position and financial viability.

FAQs

Q: What is GLUMETZA used for?

A: GLUMETZA is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Q: How effective is GLUMETZA in clinical trials?

A: GLUMETZA has been shown to be at least as effective as immediate-release metformin in all measures of glycemic control, including HbA1c levels, fasting plasma glucose, and body weight.

Q: What are the key drivers of the metformin hydrochloride tablets market?

A: The key drivers include the rising prevalence of type 2 diabetes and the growing geriatric population.

Q: Which region is expected to dominate the metformin hydrochloride tablets market?

A: North America is expected to dominate the market due to the high incidence of type 2 diabetes and the growing elderly population.

Q: How does GLUMETZA compare to GLP-1 receptor agonists?

A: While GLUMETZA is effective in glycemic control, GLP-1 receptor agonists offer additional benefits such as weight loss and cardiovascular risk reduction, making them a growing alternative in the treatment of type 2 diabetes.

Sources

1. GLUMETZA Label: FDA, "GLUMETZA (metformin hydrochloride) tablets, film coated, extended release."
2. Fortune Business Insights: "Metformin Hydrochloride Tablets Market Size, Industry Share & Forecast 2023-2030."
3. Grand View Research: "GLP-1 Receptor Agonist Market Size & Share Report, 2030."
4. GlobalData: "Net Present Value Model: Glumetza."