CLINICAL TRIALS PROFILE FOR GLUCOPHAGE

505(b)(2) Clinical Trials for GLUCOPHAGE

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 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 GLUCOPHAGE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00032474 ↗	Ginkgo Biloba Extract and the Insulin Resistance Syndrome	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 1/Phase 2	2001-12-01	The purpose of this study is to examine whether the ingestion of the herbal dietary supplement Ginkgo biloba extract has any effect on the efficacy of three classes of diabetic medications - (Glucotrol, Glucophage and Actose). Additionally, the study will examine the effect of Ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects between the ages of 20 and 75 years old.
NCT00038727 ↗	Diabetes Prevention Program Outcomes Study	Active, not recruiting	American Diabetes Association	Phase 3	2002-09-01	The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
NCT00038727 ↗	Diabetes Prevention Program Outcomes Study	Active, not recruiting	Centers for Disease Control and Prevention	Phase 3	2002-09-01	The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
NCT00038727 ↗	Diabetes Prevention Program Outcomes Study	Active, not recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2002-09-01	The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
NCT00038727 ↗	Diabetes Prevention Program Outcomes Study	Active, not recruiting	General Clinical Research Program	Phase 3	2002-09-01	The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
NCT00038727 ↗	Diabetes Prevention Program Outcomes Study	Active, not recruiting	Indian Health Service	Phase 3	2002-09-01	The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%. DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations. The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.

Clinical Trial Conditions for GLUCOPHAGE

Condition Name

Condition Name for GLUCOPHAGE
Intervention	Trials
Healthy	36
Type 2 Diabetes Mellitus	34
Type 2 Diabetes	28
Diabetes Mellitus, Type 2	22

Condition MeSH

Condition MeSH for GLUCOPHAGE
Intervention	Trials
Diabetes Mellitus	94
Diabetes Mellitus, Type 2	82
Insulin Resistance	24
Polycystic Ovary Syndrome	21

Clinical Trial Locations for GLUCOPHAGE

Trials by Country

Trials by Country for GLUCOPHAGE
Location	Trials
United States	456
China	99
Canada	41
India	25
United Kingdom	21

Trials by US State

Trials by US State for GLUCOPHAGE
Location	Trials
Texas	34
California	33
Ohio	22
Pennsylvania	21
New York	20

Clinical Trial Progress for GLUCOPHAGE

Clinical Trial Phase

Clinical Trial Phase for GLUCOPHAGE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	66

Clinical Trial Status

Clinical Trial Status for GLUCOPHAGE
Clinical Trial Phase	Trials
Completed	210
Recruiting	39
Unknown status	34

Clinical Trial Sponsors for GLUCOPHAGE

Sponsor Name

Sponsor Name for GLUCOPHAGE
Sponsor	Trials
National Cancer Institute (NCI)	22
AstraZeneca	20
Merck Sharp & Dohme Corp.	19

Sponsor Type

Sponsor Type for GLUCOPHAGE
Sponsor	Trials
Other	389
Industry	171
NIH	66

Clinical Trials Update, Market Analysis, and Projection for Glucophage (Metformin)

Last updated: October 30, 2025

Introduction

Glucophage, generically known as metformin, remains one of the most prescribed medications globally for the management of type 2 diabetes mellitus. Its enduring relevance stems from a well-established efficacy profile, affordability, and favorable safety profile. As the landscape of diabetes management evolves with emerging therapies, continual evaluation of clinical developments, market dynamics, and future forecasts is essential for stakeholders. This report provides a comprehensive update on glucohage’s clinical trial landscape, market status, and projections to inform strategic decision-making.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Metformin’s scope has expanded beyond glycemic control into areas such as obesity, polycystic ovary syndrome (PCOS), and potential anti-aging effects. Recent clinical trials focus on these novel applications and include:

• Anti-Aging and Longevity: Multiple trials explore metformin's role in extending lifespan and healthspan. Notably, the TAME (Targeting Aging with Metformin) trial, initiated by the American Federation for Aging Research, aims to evaluate whether metformin can delay age-related chronic diseases in non-diabetic older adults[1].

• Cancer Prevention and Treatment: Several trials investigate metformin’s potential as an adjunct therapy in breast, pancreatic, and prostate cancers, exploiting its insulin-sensitizing and possible direct antiproliferative effects[2].

• COVID-19 Management: Some studies assess metformin's anti-inflammatory properties in COVID-19-related complications, particularly in patients with underlying metabolic disorders[3].

Regulatory and Clinical Trial Outcomes

While the majority of clinical trials reaffirm metformin's safety and efficacy, recent data highlight:

• Cardiovascular Benefits: The UKPDS (United Kingdom Prospective Diabetes Study) established reduced cardiovascular risk with metformin, reinforcing guidelines endorsing its use as first-line therapy[4].

• Safety Concerns: Rare adverse effects such as lactic acidosis continue to be monitored, but are exceedingly uncommon when contraindications are observed[5].

Future Clinical Trial Trends

Emphasis on personalized medicine, combination therapies, and non-diabetic indications suggests several imminent trial areas:

• Combination Regimens: Trials testing metformin with SGLT2 inhibitors or GLP-1 receptor agonists aim to optimize glycemic control and weight management.

• Biomarker-Driven Studies: Precision medicine approaches involve stratifying patients based on genetic or metabolic biomarkers to maximize therapeutic benefits.

• Aging and Neurodegenerative Disorders: Early-phase trials are investigating metformin's neuroprotective potential in Alzheimer’s disease and Parkinson’s disease.

Market Analysis

Current Market Dynamics

Metformin's global market remains robust due to its widespread prescription and cost-effectiveness. Key factors include:

• Market Penetration: Estimated to serve over 100 million patients annually over diverse geographies, particularly in emerging markets like India and China[6].

• Manufacturing & Patent Landscape: Several generic manufacturers dominate, with no recent patents filed for the original compound in most jurisdictions, ensuring competitive pricing.

• Regulatory Status: Approved by the FDA, EMA, and other agencies for type 2 diabetes; some countries are exploring expanded indications.

Market Drivers

• Rising Diabetes Prevalence: Global diabetes prevalence exceeds 537 million adults, with projections reaching 700 million by 2045, underpinning sustained demand[7].

• Cost-Effectiveness: As a low-cost, well-established medication, metformin remains the first-line option, especially in low-income settings.

• Expanding Therapeutic Indications: Growing research into non-diabetes applications could diversify revenue streams.

Market Challenges

• Emergence of Novel Therapies: GLP-1 receptor agonists, SGLT2 inhibitors, and combination drugs offer superior glucose-lowering efficacy and cardiovascular benefits, potentially cannibalizing metformin's market share in certain segments.

• Regulatory and Safety Concerns: Widespread use raises surveillance needs for rare adverse events, which could influence prescribing patterns.

• Patent Expirations: Generics ensure low pricing; limited exclusivity diminishes potential for premium pricing strategies.

Market Forecast and Future Projections

Analysts project the metformin market to maintain steady growth, driven primarily by:

• Continued Global Diabetes Burden: The growing prevalence sustains demand.

• Expanded Indications: Neurodegenerative and aging-related indications could open new markets, potentially adding an incremental CAGR of 2-4% over the next decade[8].

• Geographic Expansion: Markets in Asia, Africa, and Latin America will account for most growth, owing to population size and rising disease burden.

The global metformin market is anticipated to reach USD 3.0-3.5 billion by 2030, with regional variations depending on regulatory developments and healthcare infrastructure.

Strategic Implications

• Manufacturers should carve niche segments via clinical research, particularly on aging and cancer indications, to diversify revenue.

• Industry players need to monitor regulatory policies and emerging competition carefully, especially regarding combination therapies.

• R&D investments in personalized medicine and biomarker-driven approaches will define future competitive edges.

Key Takeaways

• Clinical research on metformin continues to evolve, with promising trials in aging, oncology, and COVID-19, potentially expanding its therapeutic footprint.

• Market dynamics favor metformin’s sustained global presence, driven by high prevalence, affordability, and broad acceptance.

• Emerging competitors and innovative therapies pose challenges, requiring strategic differentiation through novel indications and personalized approaches.

• Future projections suggest steady growth, with expansion into anti-aging and neurodegenerative markets likely complementing traditional diabetes applications.

• Stakeholders should prioritize clinical research, regulatory agility, and geographic expansion to capitalize on unmet needs and emerging opportunities.

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FAQs

1. What are the most recent clinical developments involving metformin?
Recent trials focus on its potential for anti-aging (e.g., TAME), cancer prevention, and COVID-19 management. These studies aim to establish new indications and elucidate underlying mechanisms.

2. How does the market for Glucophage compare globally?
The market remains highly fragmented, with significant demand in emerging economies. The absence of patent protection for the original molecule ensures competitive pricing, while generics dominate the landscape.

3. Are there any safety concerns with long-term metformin use?
While generally safe, rare cases of lactic acidosis have been reported mainly in contraindicated populations. Ongoing pharmacovigilance continues to affirm its safety profile when used appropriately.

4. How might upcoming clinical trials impact the future of metformin?
Positive outcomes—especially in aging and cancer—could lead to regulatory approvals for new indications, expanding markets and clinical use beyond diabetes management.

5. What strategic moves should industry players consider?
Investing in research for non-traditional indications, expanding geographic reach, and engaging in personalized medicine innovations can secure competitive advantages amid evolving therapeutic landscapes.

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References

1. Barzilai N, et al. "The TAME trial: targeting aging with metformin." J Gerontol A Biol Sci Med Sci. 2016;71(4):451–452.
2. Dowling RJ, et al. "Metformin in cancer: Opportunities and challenges." J Clin Oncol. 2016;34(26):3130–3132.
3. Clementi N, et al. "Potential role of metformin in COVID-19." Front Endocrinol (Lausanne). 2020;11:583546.
4. UKPDS Group. "Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes." Lancet. 1998;352(9131):854–865.
5. Salpeter SR, et al. "Lactic acidosis in patients with diabetes treated with metformin: a systematic review." Ann Intern Med. 2010;152(9):532–539.
6. World Health Organization. "Global Report on Diabetes." 2016.
7. International Diabetes Federation. "IDF Diabetes Atlas, 9th edition." 2019.
8. MarketsandMarkets. "Global Diabetes Drugs Market." 2021.

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