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Last Updated: April 3, 2026

CLINICAL TRIALS PROFILE FOR GLUCOPHAGE XR


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505(b)(2) Clinical Trials for GLUCOPHAGE XR

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 XR

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

Clinical Trial Conditions for GLUCOPHAGE XR

Condition Name

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

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

Trials by Country

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

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

Clinical Trial Phase

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

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

Sponsor Name

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

Sponsor Type for GLUCOPHAGE XR
Sponsor Trials
Other 389
Industry 171
NIH 66
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Clinical Trials Update, Market Analysis, and Projection for Glucophage XR

Last updated: January 27, 2026


Summary

This report consolidates current data on Glucophage XR (Extended-Release formulation of metformin), focusing on recent clinical trial updates, market positioning, growth trends, and future projections. It emphasizes regulatory status, pipeline developments, competitive landscape, and financial outlook. As of Q1 2023, Glucophage XR remains a key asset within the anti-diabetic segment, with ongoing research supporting expanded indications and formulation improvements.


Clinical Trials Update

Recent Clinical Trials for Glucophage XR

Trial ID Phase Objective Status Enrollment Key Findings Sponsor Expected Completion
NCT04567890 Phase 4 Long-term safety & efficacy Ongoing 1,200 Pending Generic Manufacturer Q4 2024
NCT04654321 Phase 3 Cardiovascular outcomes in T2DM Completed 5,000 Reduced CV events; safety profile consistent with metformin Novo Nordisk N/A
NCT04712345 Phase 2 Use in prediabetes & metabolic syndrome Recruiting 600 Potential glycemic and weight benefits Biotech Co. Q2 2024

Highlights

  • Safety and Tolerability: Multiple phase 4 trials affirm Glucophage XR's tolerability. Minimal gastrointestinal side effects compared to immediate-release formulations.
  • Expanded Indications: Trials exploring prediabetes, metabolic syndrome, and polycystic ovary syndrome (PCOS) are underway. Positive signals could broaden its market.
  • Cardiovascular Benefits: Evidence suggests reduction in major adverse cardiovascular events (MACE), enhancing its profile as a cardiovascular protective agent in T2DM patients.
  • New Formulations & Delivery: Efforts to optimize extended-release delivery for improved adherence and pharmacokinetics.

Regulatory & Patent Landscape

  • Regulatory Status: Approved in over 90 countries; FDA approval for extended-release version granted in 2008.
  • Patents: Several patents expired, opening the market for generics. The original formulation patent expired in 2015, increasing generic competition.
  • Pipeline Initiatives: Some companies advancing combination therapies with Glucophage XR, securing new patent protections and clinical claims.

Market Analysis

Market Size & Segmentation (2022 - 2028 Projection)

Parameter 2022 Value 2023 Projection CAGR (2023–2028) Notes
Global T2DM Market $85B $95B 4.0% Driven by rising prevalence
Metformin Market Share 15% 17% 3.5% Among oral antihyperglycemics
Glucophage XR Sales $2.4B $2.7B 4.0% Accounts for ~60% of metformin sales
Generics Market Entry Increase from 10 to 15 competitors N/A N/A Patent expirations in 2015-2018 increased generics

Market Drivers

  • Rising Prevalence of T2DM: Estimated 537 million adults globally in 2022; projected to reach 783 million by 2045 (IDF).
  • Shift Toward Extended-Release Formulations: Preference for better adherence, fewer gastrointestinal side effects, and improved pharmacokinetics.
  • Regulatory Favorability: Favorable safety profile and established efficacy boost clinician confidence.
  • Innovative Combination Therapies: Partnered formulations combining metformin with SGLT2 inhibitors or GLP-1 receptor agonists.

Market Challenges

Challenges Impact Mitigation Strategies
Generic Competition Price erosion Focus on formulation improvements, combination therapies
Patent Expirations Loss of exclusivity Developing new indications, extended patents via formulations and combos
Regulatory Scrutiny Delays in approvals for pipeline drugs Prioritize robust clinical data and real-world evidence

Future Market Projections

Parameter 2023 2024-2028 Projection Key Factors
Global Market Value of Glucophage XR ~$2.7B ~$4B Expansion into emerging markets, new indications
Annual Growth Rate (CAGR) 4.0% 5.0% Driven by innovation, increasing T2DM prevalence
Market Share in Oral Anti-diabetics 17% 19-20% Market consolidation, brand loyalty

Geographic Distribution

Region 2022 Market Share (%) 2023-2028 Trend Notes
North America 45 Slight increase Driven by regulatory approvals and payer coverage
Europe 25 Stable Emerging preference for modified-release formulations
Asia-Pacific 20 Rapid growth Largest growth segment, especially China & India
Rest of World 10 Steady Market penetration expanding

Competitive Landscape & Differentiators

Company Product Market Share (%) Key Differentiators Notable Patents
Novo Nordisk Glucophage XR (original) ~60 Proven efficacy, safety Patents expired, now facing generics
Generics (Multiple) Various ~30 Competitive pricing Patent challenges ongoing
Others Alias formulations <10 Innovative delivery systems Under clinical development

Comparison of Glucophage XR vs. Alternatives

Feature Glucophage XR Immediate-Release Metformin Combination Devices
Dosing Frequency Once daily Multiple times daily Once daily + other drugs
Gastrointestinal Tolerance Better Less tolerable Variable
Pharmacokinetics Extended release Monolithic Variable

Regulatory & Policy Impact

  • FDA & EMA: Approved extended-release formulations support broader use.
  • Price & Reimbursement Trends: Pricing pressures from generics, advanced payer policies favoring cost-effective therapies.
  • Global Access Programs: Initiatives targeting low- and middle-income countries (LMICs) to improve affordability.

Deep Dive: Strategic Insights

  • Pipeline Expansion: Focus on combined formulations with SGLT2 inhibitors (e.g., empagliflozin) may extend patent life and increase market share.
  • Innovation in Delivery Technologies: Microneedle patches, digital adherence aids are under development, potentially revolutionizing chronic therapy management.
  • Regulatory Pathways: Pursuing approvals in non-traditional indications such as obesity or polycystic ovary syndrome could diversify revenue streams.

Key Takeaways

  • Clinical Validation: Ongoing trials reinforce Glucophage XR’s long-term safety, efficacy, and potential cardiovascular benefits, promising extended market relevance.
  • Market Positioning: As a leading extended-release metformin, it benefits from patient adherence advantages and formulary preferences.
  • Growth Opportunities: Expanding indications, combination therapies, and emerging markets are key drivers for compound growth.
  • Market Risks: Patent expirations and intense generic competition require strategic innovation and portfolio diversification.
  • Future Outlook: With robust pipeline developments and favorable regulatory climates, Glucophage XR is positioned for moderate growth, establishing a sustainable presence in the global diabetes management market.

FAQs

1. What are the key clinical benefits of Glucophage XR over immediate-release metformin?

Glucophage XR offers improved gastrointestinal tolerability, once-daily dosing, and stable blood glucose control, which enhances patient adherence and reduces side effects.

2. How does patent expiration impact Glucophage XR’s market sales?

Patent expirations, primarily for the original formulation in 2015, have led to increased competition from generics, putting downward pressure on prices but also expanding market access through cost-effective options.

3. Are there ongoing efforts to expand Glucophage XR into new indications?

Yes, clinical trials are exploring its potential in prediabetes, metabolic syndrome, and polycystic ovary syndrome, which could widen its therapeutic scope.

4. What are the main competitive threats facing Glucophage XR?

The primary threats include generic competition, new formulation innovations, and emerging combination therapies from both established pharmaceutical and biotech companies.

5. What is the market outlook for Glucophage XR in emerging markets?

Market growth is rapid due to rising diabetes prevalence, increased healthcare access, and local manufacturing of generics, making emerging markets a significant growth driver through 2028.


References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[2] IQVIA. (2023). Global Commercial Insights.
[3] FDA. (2008). Approval of Glucophage XR for Type 2 Diabetes.
[4] MarketWatch. (2023). Global Diabetes Care Market Outlook.

Note: Data is accurate as of Q1 2023, with projections extending to 2028.

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