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.
NCT00038727 ↗	Diabetes Prevention Program Outcomes Study	Active, not recruiting	National Cancer Institute (NCI)	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	27
Diabetes Mellitus, Type 2	22

Condition MeSH

Condition MeSH for Glucophage
Intervention	Trials
Diabetes Mellitus	94
Diabetes Mellitus, Type 2	81
Insulin Resistance	23
Polycystic Ovary Syndrome	21

Clinical Trial Locations for Glucophage

Trials by Country

Trials by Country for Glucophage
Location	Trials
United States	456
China	98
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
Phase 4	66
Phase 3	49
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for Glucophage
Clinical Trial Phase	Trials
Completed	210
Recruiting	37
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	388
Industry	171
NIH	66

GLUCOPHAGE (Metformin): Clinical Trials, Market Analysis, and Projections

Introduction to GLUCOPHAGE (Metformin)

GLUCOPHAGE, commonly known by its generic name metformin, is a widely used medication for the treatment of type 2 diabetes. It has been a cornerstone in diabetes management for decades, and its applications are being explored in various other medical conditions.

Clinical Trials Update

COVID-19 and Metformin

Recent discussions have centered around the potential role of metformin in the management of COVID-19. A study on the TOGETHER platform trial indicated that metformin might have a place in the treatment of COVID-19, particularly in evaluating outcomes such as the need for emergency care or the prevention of post-COVID conditions. However, the study also highlighted that the patient population in current trials differs significantly from those in earlier studies due to the presence of vaccines and natural immunity[1].

Multiple Sclerosis (MS) Trials

Metformin is being tested in clinical trials for its potential in treating multiple sclerosis (MS). The Cambridge trial, for instance, is investigating the remyelinating effects of metformin in combination with clemastine, a hay fever drug. These trials aim to explore metformin's role in myelin repair and its potential as a treatment for progressive MS[4].

Market Analysis

Global Market Size and Growth

The global metformin market was valued at USD 4028 million in 2022 and is projected to reach USD 6420.02 million by 2030, growing at a CAGR of 6.0%. This growth is driven by several factors, including the increasing prevalence of type 2 diabetes, rising obesity rates, and an aging population[3].

Regional Market Insights

• North America and Europe: These regions have a well-established market for diabetes drugs, including metformin. The market is forecasted to grow moderately, driven by policies, regulations, and price trends. For example, in North America, the market is expected to see significant growth due to the high prevalence of diabetes and the availability of various distribution channels such as hospital pharmacies, retail pharmacies, and online pharmacies[2].
• Asia Pacific: This region, particularly China, has a large and growing market for metformin. China has the highest number of diabetic patients globally, with a prevalence rate of 12.8% among adults. The market in China is expected to experience restorative growth post-COVID-19, with several manufacturers, including Sino-US Shanghai Squibb Pharmaceutical Co., Ltd., holding significant market shares[5].
• Latin America and Middle East & Africa: These regions offer emerging markets with untapped potential for metformin sales. The increasing prevalence of diabetes and aging populations in these regions are expected to drive market growth[2].

Market Drivers and Opportunities

• Increasing Prevalence of Diabetes: The global rise in type 2 diabetes diagnoses is a major driver of the metformin market.
• Growing Awareness and Adoption: Increased awareness among healthcare professionals and patients about the benefits of metformin has contributed to its widespread adoption.
• Aging Population: The risk of developing type 2 diabetes increases with age, making the aging population a significant driver.
• Expansion in Emerging Markets: Pharmaceutical companies have opportunities to expand their presence in emerging markets where diabetes is rising rapidly.
• Technological Advancements: Improvements in drug delivery systems and formulations can enhance patient compliance and convenience[3].

Market Restraints and Challenges

• Side Effects and Safety Concerns: Metformin can cause gastrointestinal disturbances and, rarely, lactic acidosis, which may limit its use.
• Patent Expiry and Generic Competition: The availability of generic versions of metformin can reduce the market share of branded products[3].

Market Projections

Forecast by Therapy

The market for metformin is expected to grow across various therapeutic categories, including glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl-peptidase-4 (DPP-4) inhibitors, sodium glucose co-transporter 2 (SGLT2) inhibitors, and insulin. However, metformin remains a staple in the treatment of type 2 diabetes due to its effectiveness and affordability[2].

Forecast by Disease Type

The market is segmented by disease type, with type 2 diabetes being the primary driver. The prevalence of type 2 diabetes is expected to continue rising, thereby driving the demand for metformin. Other segments, such as type 1 diabetes, gestational diabetes, and impaired glucose tolerance, also contribute to the market but to a lesser extent[2].

Forecast by Distribution Channel

The distribution channels for metformin include hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility offered by online pharmacies are expected to increase their market share in the coming years[2].

Key Trends

• Increasing Use in Combination Therapies: Metformin is often used in combination with other diabetes medications to achieve better glycemic control.
• Focus on Patient Compliance: Efforts to improve drug delivery systems and formulations aim to enhance patient compliance and convenience.
• Expansion into New Indications: The potential use of metformin in conditions like COVID-19 and MS is being explored, which could expand its market beyond traditional diabetes treatment[1][4].

Key Takeaways

• Clinical Trials: Metformin is being explored for its potential in treating COVID-19 and multiple sclerosis.
• Market Growth: The global metformin market is projected to grow at a CAGR of 6.0% from 2022 to 2030.
• Regional Insights: Asia Pacific, particularly China, is a significant market due to the high prevalence of diabetes.
• Market Drivers: Increasing diabetes prevalence, aging population, and technological advancements are key drivers.
• Challenges: Side effects, safety concerns, and generic competition are restraints to the market.

FAQs

What is the current market size of the global metformin market?

The global metformin market was valued at USD 4028 million in 2022[3].

What is the projected growth rate of the global metformin market?

The global metformin market is expected to grow at a CAGR of 6.0% from 2022 to 2030[3].

Which region has the highest market share for metformin?

The Asia Pacific region, particularly China, has the highest market share due to the large number of diabetic patients[5].

What are the potential new indications for metformin?

Metformin is being explored for its potential in treating COVID-19 and multiple sclerosis[1][4].

What are the main challenges facing the metformin market?

The main challenges include side effects and safety concerns, as well as patent expiry and generic competition[3].

Sources

1. Coronavirus disease 2019 (COVID-19) is a different disease in 2024 than it was in early 2020... - Academic.oup.com
2. Diabetes Drugs Market by Therapy, Disease, & Forecast - 2025 - Transparency Market Research
3. Metformin Market Size, Share, Statistics & Industry Forecast By 2030 - Data Bridge Market Research
4. Metformin - MS Society - MS Society
5. Investigation Report on China's Metformin Market 2021-2025 - GlobeNewswire