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Last Updated: May 16, 2025

CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE


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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).
New Combination NCT05641337 ↗ Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes Recruiting Huashan Hospital Phase 3 2022-10-01 Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT00004992 ↗ Diabetes Prevention Program Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Metformin Hydrochloride

Condition Name

Condition Name for Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 459
Type 2 Diabetes Mellitus 386
Type 2 Diabetes 261
Diabetes 155
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Condition MeSH

Condition MeSH for Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 1276
Diabetes Mellitus, Type 2 1236
Polycystic Ovary Syndrome 163
Syndrome 146
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Clinical Trial Locations for Metformin Hydrochloride

Trials by Country

Trials by Country for Metformin Hydrochloride
Location Trials
Canada 749
Egypt 97
Slovakia 94
Taiwan 87
Denmark 84
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Trials by US State

Trials by US State for Metformin Hydrochloride
Location Trials
Texas 424
California 422
Florida 362
Ohio 281
North Carolina 277
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Clinical Trial Progress for Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 592
Phase 3 630
Phase 2/Phase 3 76
[disabled in preview] 530
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Clinical Trial Status

Clinical Trial Status for Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 1603
Recruiting 258
Unknown status 215
[disabled in preview] 344
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Clinical Trial Sponsors for Metformin Hydrochloride

Sponsor Name

Sponsor Name for Metformin Hydrochloride
Sponsor Trials
AstraZeneca 153
Novo Nordisk A/S 136
Eli Lilly and Company 117
[disabled in preview] 201
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Sponsor Type

Sponsor Type for Metformin Hydrochloride
Sponsor Trials
Other 2199
Industry 1590
NIH 155
[disabled in preview] 38
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Metformin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Metformin Hydrochloride

Metformin hydrochloride is a widely used oral antidiabetic drug in the biguanide class that is primarily used to treat type 2 diabetes mellitus (T2DM). It works by reducing glucose production in the liver, improving insulin sensitivity, and enhancing glucose uptake by muscles.

Clinical Trials Update

Efficacy and Safety in T2DM

A recent clinical trial compared the efficacy and safety of metformin hydrochloride sustained-release (SR) tablets produced by Dulening with the original metformin hydrochloride tablets produced by Glucophage. This randomized, open, and parallel controlled clinical trial involved 886 patients with T2DM across 40 clinical centers between May 2016 and December 2018. The results showed that both forms of metformin effectively reduced fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) levels, with comparable efficacy. Additionally, both forms significantly reduced body weight in patients. The incidence of adverse drug reactions, particularly gastrointestinal reactions, was also comparable between the two groups[1].

Emerging Uses

Beyond its primary use in T2DM, metformin is being explored in clinical trials for other conditions. For instance, it is being tested for its potential in treating multiple sclerosis (MS). Clinical trials are investigating metformin as a myelin repair treatment for MS, both alone and in combination with other drugs like clemastine[4].

Market Analysis

Global Market Size and Growth

The global metformin hydrochloride tablet market is significant and continues to evolve. As of 2025, the market was valued at $3,560 million, although it is projected to decline at a CAGR of -5.6% from 2025 to 2033. This decline is attributed to the increasing adoption of newer anti-diabetic drugs and potential side effects associated with metformin, such as gastrointestinal issues and lactic acidosis[2].

However, other reports suggest a more positive outlook. The global metformin hydrochloride market was valued at $392 million in 2023 and is expected to reach $565 million by 2030, growing at a CAGR of 5.4% during the forecast period of 2024-2030[5].

Market Drivers

Several factors drive the growth of the metformin hydrochloride market:

  • Rising Prevalence of Type 2 Diabetes: The increasing number of people diagnosed with T2DM is a primary driver for the market.
  • Growing Geriatric Population: Older adults are more likely to develop diabetes, contributing to the demand for metformin.
  • Increasing Healthcare Expenditure: Greater investment in healthcare, including diabetes management, boosts the market.
  • Government Initiatives: Policies aimed at promoting diabetes management also support market growth[2][5].

Market Segmentation

The market is segmented by application, type, and region:

  • Application: The hospital segment accounts for the largest share, followed by drug stores.
  • Types: Metformin hydrochloride tablets are available in various pack sizes, with 50 and 100 tablets being the most popular.
  • Region: The Asia-Pacific region is expected to be the largest market, followed by North America and Europe[2][5].

Key Players

The market is dominated by several key manufacturers, including Keyuan Pharmaceutical, Aarti Drugs, and Shijiazhuang Polee Pharmaceutical. Keyuan Pharmaceutical holds the largest market share, exceeding 14%[5].

Market Projections

Growth Projections

Despite the projected decline in some reports, the overall trend suggests a stable to growing market. The market is expected to reach $565 million by 2030, driven by the increasing prevalence of type 2 diabetes and other factors such as the growing geriatric population and increasing healthcare expenditure[5].

Regional Insights

India is the largest market for metformin hydrochloride, accounting for a significant share of the global market. The Asia-Pacific region, in general, is expected to continue its dominance due to the high prevalence of diabetes and increasing healthcare spending[5].

Product Type Insights

Metformin HCL is the largest market segment, accounting for more than 82% of the market. Metformin hydrochloride tablets are the most common form, with a market share of about 72%[5].

Challenges and Opportunities

Challenges

  • Side Effects: Gastrointestinal issues and the risk of lactic acidosis are significant challenges that could impact market growth.
  • Newer Anti-Diabetic Drugs: The adoption of newer, potentially more effective or safer anti-diabetic drugs could reduce the demand for metformin hydrochloride[2].

Opportunities

  • Emerging Markets: Increasing demand for diabetes medications in emerging markets presents a significant opportunity for growth.
  • Generic Drugs: The growing popularity of generic drugs, including metformin hydrochloride, can expand market reach and affordability[2][5].

Key Takeaways

  • Clinical Efficacy: Metformin hydrochloride, including sustained-release forms, has been shown to be effective and safe in treating T2DM.
  • Market Growth: Despite some projections of decline, the market is expected to grow driven by the rising prevalence of type 2 diabetes and other factors.
  • Regional Dominance: The Asia-Pacific region, particularly India, will continue to be a major market for metformin hydrochloride.
  • Product Segmentation: Metformin HCL and tablets will remain the dominant forms in the market.

FAQs

What is the primary use of metformin hydrochloride?

Metformin hydrochloride is primarily used to treat type 2 diabetes mellitus (T2DM) by reducing glucose production in the liver and improving insulin sensitivity.

What are the emerging uses of metformin hydrochloride?

Metformin is being tested in clinical trials for its potential in treating multiple sclerosis (MS), particularly as a myelin repair treatment.

What is the current market size and growth projection for metformin hydrochloride?

The global metformin hydrochloride market was valued at $392 million in 2023 and is expected to reach $565 million by 2030, growing at a CAGR of 5.4% during the forecast period.

Which region dominates the metformin hydrochloride market?

The Asia-Pacific region, particularly India, dominates the metformin hydrochloride market due to the high prevalence of diabetes and increasing healthcare spending.

What are the main challenges facing the metformin hydrochloride market?

The main challenges include potential side effects such as gastrointestinal issues and lactic acidosis, as well as the increasing adoption of newer anti-diabetic drugs.

Sources

  1. Frontiers in Endocrinology: "Comparison of Clinical Efficacy and Safety of Metformin Hydrochloride Sustained-Release (SR) Tablet (II) Produced by Dulening and the Original Metformin Hydrochloride Tablet Produced by Glucophage in the Treatment of Type 2 Diabetes Mellitus (T2DM)".
  2. Data Insights Market: "Metformin Hydrochloride Tablet Unlocking Growth Potential: 2025".
  3. Biospace: "Metformin Hydrochloride Market Analysis, Industry Size, Share, Leaders, Current Status by Major Key Vendors and Trends by Forecast to 2027".
  4. MS Society: "Metformin - MS Society".
  5. Valuates Reports: "Global Metformin Hydrochloride Market Research Report 2024".
Last updated: 2025-01-01

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