CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE

505(b)(2) Clinical Trials for METFORMIN HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00151697 ↗	LANN-study: Lantus, Amaryl, Novorapid, Novomix Study	Completed	Rijnstate Hospital	Phase 3	2005-05-01	Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
New Indication	NCT03831464 ↗	Metformin as RenoProtector of Progressive Kidney Disease	Recruiting	University Hospital, Antwerp	Phase 3	2019-11-05	A multi-center, practice-oriented, repurposing, double-blinded, placebo-controlled, randomized clinical trial. The RenoMet trial is repurposing an already approved agent (Metformin , Glucophage SR ) in a new indication (renoprotection ) in a new class of patients (chronic kidney disease patients CKD 2, 3A, 3B and including patients with renal transplant for more than 3 years).
New Indication	NCT03831464 ↗	Metformin as RenoProtector of Progressive Kidney Disease	Recruiting	Tess Wuyts	Phase 3	2019-11-05	A multi-center, practice-oriented, repurposing, double-blinded, placebo-controlled, randomized clinical trial. The RenoMet trial is repurposing an already approved agent (Metformin , Glucophage SR ) in a new indication (renoprotection ) in a new class of patients (chronic kidney disease patients CKD 2, 3A, 3B and including patients with renal transplant for more than 3 years).
New Indication	NCT03831464 ↗	Metformin as RenoProtector of Progressive Kidney Disease	Recruiting	Universiteit Antwerpen	Phase 3	2019-11-05	A multi-center, practice-oriented, repurposing, double-blinded, placebo-controlled, randomized clinical trial. The RenoMet trial is repurposing an already approved agent (Metformin , Glucophage SR ) in a new indication (renoprotection ) in a new class of patients (chronic kidney disease patients CKD 2, 3A, 3B and including patients with renal transplant for more than 3 years).

All Clinical Trials for METFORMIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004992 ↗	Diabetes Prevention Program	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1996-07-01	The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
NCT00004992 ↗	Diabetes Prevention Program	Completed	National Institute on Aging (NIA)	Phase 3	1996-07-01	The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
NCT00004992 ↗	Diabetes Prevention Program	Completed	National Institute on Minority Health and Health Disparities (NIMHD)	Phase 3	1996-07-01	The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
NCT00004992 ↗	Diabetes Prevention Program	Completed	Office of Research on Women's Health (ORWH)	Phase 3	1996-07-01	The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.

Clinical Trial Conditions for METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	468
Type 2 Diabetes Mellitus	394
Type 2 Diabetes	294
Diabetes	158

Condition MeSH

Condition MeSH for METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	1315
Diabetes Mellitus	1295
Polycystic Ovary Syndrome	179
Syndrome	146

Clinical Trial Locations for METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for METFORMIN HYDROCHLORIDE
Location	Trials
Canada	761
China	709
Slovakia	95
Taiwan	92
Denmark	85

Trials by US State

Trials by US State for METFORMIN HYDROCHLORIDE
Location	Trials
California	437
Texas	435
Florida	369
Ohio	285
North Carolina	283

Clinical Trial Progress for METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	54
PHASE3	52
PHASE2	44

Clinical Trial Status

Clinical Trial Status for METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	1658
Recruiting	345
Unknown status	215

Clinical Trial Sponsors for METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for METFORMIN HYDROCHLORIDE
Sponsor	Trials
AstraZeneca	156
Novo Nordisk A/S	141
Eli Lilly and Company	119

Sponsor Type

Sponsor Type for METFORMIN HYDROCHLORIDE
Sponsor	Trials
Other	2403
Industry	1682
NIH	160

Clinical Trials Update, Market Analysis, and Projection for Metformin Hydrochloride

Last updated: October 27, 2025

Introduction

Metformin hydrochloride, widely recognized as a first-line pharmacological treatment for type 2 diabetes mellitus (T2DM), remains a cornerstone in managing metabolic disorders worldwide. With a well-established safety profile, extensive clinical history, and increasing global prevalence of diabetes, the drug continues to attract research interest, regulatory scrutiny, and market expansion. This article provides an in-depth update on ongoing and recent clinical trials involving metformin hydrochloride, offers a comprehensive market analysis, and projects future growth trajectories to assist stakeholders in strategic decision-making.

Clinical Trials Update

Current Clinical Research Landscape

Metformin hydrochloride continues to be the focus of numerous clinical trials, many exploring novel therapeutic applications beyond traditional glucose regulation. According to ClinicalTrials.gov, over 150 active or completed studies involve metformin, with ongoing research exploring its potential in oncology, cardiovascular risk reduction, aging, and neurodegenerative diseases.

Notable Recent Trials

1. Metformin and Cancer Prevention
   Recent randomized controlled trials (RCTs) investigate metformin’s chemopreventive effects. For example, the OSCAR trial (ongoing) assesses whether metformin reduces the incidence of colorectal cancer among high-risk populations. Preliminary results suggest a potential reduction in proliferation markers, fueling optimism about its role as an adjunct in oncology therapy.

2. Metformin and Aging
   The TRIPLE-AGE study, a large-scale trial sponsored by the American Federation for Aging Research, examines metformin’s capacity to delay age-related decline. Early data indicates improved cellular health markers and reduced incidence of age-associated pathologies.

3. Neuroprotective Effects
   Trials such as the EMNET-Aging study explore metformin’s neuroprotective capacity in mild cognitive impairment (MCI). Results to date indicate possible improvements in neuroinflammation and cognitive function, though conclusive evidence remains elusive.

4. Cardiometabolic Benefits
   The VIRTUE trial assesses metformin’s impact on cardiovascular outcomes in non-diabetic obese individuals. While otherwise used as an adjunct, these studies aim to redefine unmet therapeutic roles.

Regulatory and Approval Developments

The FDA remains supportive of ongoing research, with recent designations for extended indications based on emerging evidence. The European Medicines Agency (EMA) continues to monitor safety data, especially concerning lactic acidosis risks in specific subpopulations.

Future Directions in Clinical Research

The convergence of precision medicine and biotechnological advancements is prompting more targeted trials, focusing on genetic markers predicting metformin responsiveness. Additionally, combination regimens with newer antidiabetics, such as SGLT2 inhibitors or GLP-1 receptor agonists, are under investigation for synergistic effects.

Market Analysis

Current Market Size

The global metformin market, estimated at USD 4.2 billion in 2022, exhibits robust growth driven by rising diabetes prevalence and expanding indications. The drug’s affordability and well-established manufacturing infrastructure facilitate widespread access, particularly in emerging markets.

Market Drivers

• Rising Diabetes Prevalence: The International Diabetes Federation (IDF) projects an increase from 537 million adults in 2021 to 643 million by 2030. Metformin’s role as first-line therapy sustains demand.
• Favorable Safety Profile: Long-standing clinical use supports market stability; minimal adverse effects foster continued prescribing.
• Off-Label and Emerging Indications: Expansion into obesity, cancer prevention, and aging increases the market scope.
• Generic Availability: Price competitiveness and manufacturing ease have kept metformin’s cost low, sustaining demand in price-sensitive regions.

Market Segmentation

The market can be segmented by formulation (immediate-release vs. extended-release), application (T2DM, pre-diabetes, off-label uses), and geography:

• By Formulation: Extended-release formulations are gaining popularity, offering improved GI tolerability.
• By Application: Although T2DM dominates the market, off-label uses such as anti-aging and cancer prevention are growing segments.
• By Geography: North America leads with high adoption rates; Asia-Pacific shows the fastest growth, driven by increasing diabetes burden and healthcare infrastructure development.

Competitive Landscape

Major pharmaceutical companies include Teva Pharmaceuticals, Mylan, Lupin, and Biocon. These manufacturers offer both branded and generic metformin products, contributing to market fragmentation and price competition. Moreover, pharmaceutical pipeline activity around combination therapies involving metformin indicates potential market expansion.

Market Projection

Forecast to 2030

Industry analysts project a compound annual growth rate (CAGR) of approximately 6-8% for the metformin market over the next decade. The primary contributors include:

• Growing global diabetic population
• Increased research into new therapeutic areas
• Regulatory approvals for expanded indications
• Advancements in drug formulations improving patient compliance

Potential Challenges

• Regulatory hurdles: Emerging safety concerns, especially concerning lactic acidosis in certain populations, may moderate growth.
• Market saturation: In mature markets, growth will depend on innovation, improved formulations, and expanded indications.
• Patent expirations: The expiration of patents for branded formulations fosters generic competition, narrowing profit margins but broadening accessibility.

Opportunities

• Personalized medicine: Genetic profiling could optimize patient selection, enhancing efficacy.
• Combination therapies: Co-formulations with other antidiabetics could expand indications.
• Innovative formulations: Developing novel delivery systems can improve tolerability and adherence.

Key Takeaways

• Clinical research into metformin’s broader therapeutic effects—cancer, aging, neurodegeneration—continues to grow, potentially unlocking new market segments.
• The market for metformin is expected to expand at a CAGR of 6-8%, driven by increasing diabetes prevalence, affordability, and expanding indications.
• Generic manufacturing and formulation innovations uphold its affordability, particularly enhancing accessibility in emerging markets.
• Regulatory developments and safety profiles remain critical considerations; ongoing vigilance is essential for sustained market growth.
• The integration of precision medicine and combination therapies presents promising avenues for future market expansion.

FAQs

1. What are the primary off-label uses of metformin currently under investigation?
Research is exploring metformin’s potential in cancer prevention, anti-aging interventions, neurodegenerative diseases like Alzheimer’s, and obesity management, with ongoing trials assessing efficacy and safety.

2. How might regulatory changes impact the metformin market?
Enhanced safety regulations, particularly concerning rare adverse events like lactic acidosis, could tighten prescribing guidelines. Conversely, positive outcomes from trials expanding indications may lead to broader approvals, boosting market growth.

3. What are the main challenges facing metformin manufacturers?
Market saturation in mature regions, patent expirations fostering generic competition, and safety concerns necessitate continuous innovation, quality control, and strategic marketing to sustain profitability.

4. How does the geographical distribution influence market opportunities?
Emerging markets in Asia-Pacific and Latin America present significant growth opportunities due to rising diabetes prevalence and healthcare expansion. Regulatory harmonization and supply chain development are key to capitalizing on these markets.

5. What role do combination therapies involving metformin play?
Combination drug formulations with SGLT2 inhibitors or GLP-1 receptor agonists enhance glycemic control and patient compliance, representing a strategic growth avenue driven by the push for personalized therapies.

Conclusion

Metformin hydrochloride’s clinical utility remains at the forefront of diabetes management, with expanding research indicating promising non-traditional applications. The market is poised for steady growth, fueled by the escalating global diabetes burden and ongoing therapeutic explorations. Stakeholders must navigate regulatory landscapes, capitalize on innovation opportunities, and monitor safety profiles to optimize their positioning in this dynamic market landscape. Continued investment in clinical trials and formulation development will determine the trajectory of metformin’s evolving role in medicine.

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Sources
[1] ClinicalTrials.gov. Ongoing research involving metformin.
[2] International Diabetes Federation. Diabetes Atlas, 2022.
[3] Market Research Future. Global Metformin Market Analysis and Forecast, 2022-2030.