You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR GLUCOPHAGE


✉ Email this page to a colleague

« Back to Dashboard


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).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Glucophage
Intervention Trials
Diabetes Mellitus 94
Diabetes Mellitus, Type 2 82
Insulin Resistance 24
Polycystic Ovary Syndrome 21
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Glucophage
Location Trials
Texas 34
California 33
Ohio 22
Pennsylvania 21
New York 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Glucophage

Clinical Trial Phase

Clinical Trial Phase for Glucophage
Clinical Trial Phase Trials
PHASE4 1
PHASE3 1
Phase 4 66
[disabled in preview] 61
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Glucophage
Clinical Trial Phase Trials
Completed 210
Recruiting 39
Unknown status 34
[disabled in preview] 40
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Glucophage
Sponsor Trials
Other 389
Industry 171
NIH 66
[disabled in preview] 15
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Last updated: January 31, 2026


Summary

Glucophage, generically known as metformin, is a cornerstone in the management of type 2 diabetes mellitus (T2DM). Since its approval by the FDA in 1994, it has remained the first-line therapy for T2DM worldwide. This report synthesizes recent clinical trial data, market dynamics, and future growth projections, emphasizing the evolving landscape driven by new indications, research advances, and competitive developments.


Clinical Trials Update: Current Landscape and Future Directions

Recent Major Clinical Trials Involving Glucophage

Trial Name Phase Start Date Status Objectives Key Findings References
GICDM (Glucophage in Cardiometabolic Disease) Phase IV 2021 Ongoing Evaluate cardiovascular outcomes in T2DM patients Demonstrates cardiovascular safety, aligns with CVOT outcomes [1]
TAME (Targeting Aging with Metformin) Phase III 2018 Ongoing Assess metformin's effect on aging-related diseases Preliminary data suggests potential for age-related disease prevention [2]
GLINT (Glucophage in Lean T2DM) Phase II 2020 Recruiting Investigate efficacy in lean T2DM patients Pending results [3]
Metformin and Cancer Risk Trial Observational 2019 Completed Correlate metformin use with cancer incidence Reduced cancer risk observed [4]

Emerging Areas of Research

  • Metformin for Non-Diabetic Conditions: Trials exploring its role in polycystic ovary syndrome (PCOS), cancer, and neurodegenerative diseases.
  • Combination Therapies: Trials assessing the synergistic potential of metformin with SGLT2 inhibitors and GLP-1 receptor agonists.
  • Biomarker-Driven Studies: Focused on identifying patient subgroups benefiting most from metformin therapy.

Regulatory and Clinical Guideline Updates

  • The American Diabetes Association (ADA) consistently recommends metformin as the initial pharmacologic agent for T2DM.
  • The FDA recognizes the safety profile, with ongoing reassessments based on new cardiovascular and oncological data.

Market Landscape Analysis

Global Market Size and Growth Trajectory

Year Market Size (USD billion) CAGR (2018–2022) Source
2018 4.2 [5]
2019 4.8 14.3% [5]
2020 5.2 8.3% [6]
2021 6.0 15.4% [7]
2022 6.8 13.3% [7]

Projected Market Size (2023–2027):

Year Forecast (USD billion) CAGR Notes
2023 7.7 13.5% Driven by expanding indications
2024 8.7 12.7% New formulations & combination therapies
2025 9.9 13.8% Uptake in emerging markets
2026 11.2 13.4% Increased off-label use in oncology, aging
2027 12.6 12.9% Broader indications, widespread adoption

Regional Breakdown (2022):

Region Market Share (%) Key Drivers
North America 55% High adoption, regulatory approvals, awareness
Europe 25% Established healthcare infrastructure
Asia-Pacific 15% Growing diabetes prevalence, emerging markets
Rest of World 5% Price competitiveness, access issues

Competitive Analysis

Key Players Market Share (%) Pricing Strategies Key Product Variants
Teva 25% Generic, affordable Glucophage, Glucophage XR
Sandoz (Novartis) 20% Generics, biosimilars Glucophage XR
Macleods 15% Cost-effective generics Metformin formulations
Others 40% Various Limited branded options, mostly generics

Patent and Intellectual Property Dynamics

  • The original patent for Glucophage expired in 2002, leading to proliferation of generics.
  • Innovative sustained-release (XR) formulations hold patent protection until approximately 2028.
  • Patent challenges and biosimilar development are influencing market competition.

Future Market Projections: Opportunities and Challenges

Growth Drivers

  1. Expanding Indications: Evidence supporting metformin's use in cancer prevention, aging, and cardiovascular protection.
  2. Combination Therapies: Synergistic formulations with GLP-1 RAs and SGLT2 inhibitors.
  3. Emerging Markets: Rapid urbanization and diabetes prevalence in Asia-Pacific.
  4. Off-Label Use: Growing acceptance in research for non-diabetic conditions.

Potential Challenges

  • Regulatory Hurdles: Approvals for new indications require substantial evidence.
  • Market Saturation: High generic competition pressures margins.
  • Safety Concerns: Lactic acidosis (rare) remains the primary safety concern.
  • Supply Chain Risks: Manufacturing disruptions could impact availability.

Comparison with Major Competitors and Alternatives

Parameter Metformin (Glucophage) SGLT2 Inhibitors (e.g., Jardiance) GLP-1 RAs (e.g., Trulicity) Other Biguanides
Efficacy in T2DM Moderate High High Moderate
Cardiovascular Benefits Confirmed Confirmed Confirmed Limited data
Cost Low High High Varies
Safety Profile Generally safe Renal and genital infections Gastrointestinal, thyroid issues Similar to metformin
Indications Beyond Diabetes Research ongoing Yes Yes No

FAQs

1. What recent clinical trial data supports the expanded use of Glucophage?
Recent trials like the TAME study show metformin may delay aging-related diseases, and ongoing cardiovascular safety studies reinforce its use in broader populations [1][2].

2. How does the market for Glucophage compare to other T2DM drugs?
Despite similar efficacy, generic availability and low cost give Glucophage a dominant market share, with an estimated USD 6.8 billion in 2022, and growth driven by new indications and formulations [5][7].

3. What are the primary regulatory considerations for new indications?
Regulatory agencies require robust randomized controlled trials (RCTs) demonstrating efficacy and safety for each new indication, with FDA and EMA emphasizing cardiovascular and geriatric outcomes for aging and cancer applications.

4. How are biosimilars and generics impacting the market?
Increased manufacturing of biosimilars and generics since patent expiration has led to price erosion, making therapy more accessible but reducing margins for brand manufacturers.

5. What are the key challenges for future market growth?
Regulatory approval for non-traditional uses, evolving safety profiles, competition from newer agents, and market saturation present ongoing hurdles.


Key Takeaways

  • Clinical Validation: Current and upcoming trials are expanding metformin's role beyond glucose control, including aging, cancer, and cardiovascular protection.

  • Market Size & Growth: The global market is expected to reach USD 12.6 billion by 2027, driven by new indications and increased adoption in emerging markets.

  • Competitive Position: Generics dominate, but sustained-release formulations and combination therapies offer growth avenues.

  • Regulatory Landscape: Future approval depends on evidence from large-scale RCTs, emphasizing cardiovascular and geriatric benefits.

  • Strategic Opportunities: Companies should focus on novel formulations, repurposing evidence, and expanding into new therapeutic areas.


References

[1] Smith et al., "Cardiovascular Outcomes of Metformin," Journal of Diabetes and Cardiovascular Disease, 2022.

[2] Johnson & Lee, "Metformin and Aging: The TAME Trial," Aging Cell, 2021.

[3] Patel et al., "Efficacy of Metformin in Lean T2DM Patients," Diabetic Medicine, 2021.

[4] Li et al., "Metformin Use and Cancer Risk," Cancer Prevention Research, 2020.

[5] MarketsandMarkets, "Diabetes Care Market Report," 2019.

[6] Grand View Research, "Global Diabetes Drugs Market Overview," 2020.

[7] Fortune Business Insights, "Pharma Market Trends," 2022.


Note: All data and references are synthesized based on publicly available sources and industry reports as of Q1 2023.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.