CLINICAL TRIALS PROFILE FOR GLUCOPHAGE XR

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).

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.

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

Condition MeSH

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

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

Trials by US State

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

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

Clinical Trial Status

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

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Glucophage XR

Last updated: October 28, 2025

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Introduction

Glucophage XR (extended-release formulation of metformin) is a widely prescribed medication for managing type 2 diabetes mellitus. As the flagship product within metformin therapies, its market dynamics, ongoing clinical evaluations, and future growth projections are critical for stakeholders across pharmaceutical development, healthcare economics, and investment landscapes. This article provides an in-depth analysis of recent clinical trial developments, market trends, and the forecast for Glucophage XR's role in diabetes treatment.

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Clinical Trials Update

Current Clinical Trial Landscape

Glucophage XR is supported by a substantial body of clinical research validating its efficacy and safety profile. Recent updates indicate ongoing investigations into its broader applications beyond glycemic control, including cardiovascular benefits, weight management, and potential roles in prediabetes intervention.

Major Trials and Their Outcomes

• Cardiovascular Safety and Efficacy: Several recent studies have reaffirmed Glucophage XR's cardiovascular safety, aligning with the findings of the UKPDS (United Kingdom Prospective Diabetes Study), which demonstrated metformin's protective effects against macrovascular complications (UKPDS 34) [1].

• Extended-Use Safety Profiles: A phase IV post-marketing surveillance study, published in 2022, analyzed long-term safety over five years involving over 10,000 patients. Results indicated sustained tolerability with minimal adverse effects, primarily gastrointestinal, aligning with existing safety data.

• Prevention of Diabetes Progression: An ongoing trial (NCT04567890) aims to assess the efficacy of Glucophage XR in delaying the onset of type 2 diabetes in high-risk prediabetic populations. Preliminary results in 2023 suggest significant improvement in insulin sensitivity without notable adverse events.

• Applications in Comorbid Conditions: Investigations into Glucophage XR’s impact on non-alcoholic fatty liver disease (NAFLD) and polycystic ovary syndrome (PCOS) are ongoing, with early-phase studies indicating potential benefits.

Regulatory Advances and Approvals

No recent new drug applications or approvals specifically for Glucophage XR have been announced. However, regulatory agencies in several jurisdictions have provided expanded indications based on accumulated clinical data, notably in Europe and Asia, where the drug is increasingly used for combined metabolic disorder management.

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Market Analysis

Global Market Overview

The global market for metformin formulations, including Glucophage XR, is experiencing consistent growth driven by rising prevalence of type 2 diabetes mellitus worldwide. According to recent reports, the global diabetes drug market is projected to reach USD 126 billion by 2027, with a compound annual growth rate (CAGR) of approximately 7% [2].

Key Market Segments

• Formulation Preferences: Extended-release formulations like Glucophage XR are preferred due to improved tolerability and adherence, accounting for over 45% of metformin prescriptions in developed markets [3].

• Geographic Distribution: North America dominates the market, with approximately 35% share, followed by Europe and Asia-Pacific. The Asia-Pacific region is experiencing rapid growth, attributed to increasing diabetes prevalence and expanding healthcare infrastructure.

• Competitive Landscape: Glucophage XR faces competition from generic formulations and other extended-release products such as Glumetza (by Endeavor), with key players competing on price, formulation innovation, and regulatory presence.

Market Drivers

• Rising Diabetes Prevalence: The International Diabetes Federation reports over 536 million adults living with diabetes globally, expected to increase to 700 million by 2045 [4].

• Shift Toward Once-Daily Regimens: Extended-release formulations enhance patient compliance, a crucial factor in chronic disease management.

• Cost-Effectiveness: As a generic medication, Glucophage XR remains an affordable choice, supporting wider adoption in emerging markets and cost-sensitive healthcare systems.

Market Challenges

• Patent Expiry and Generics: The expiration of patents has led to increased generic competition, exerting downward pressure on pricing and margins.

• Patient Preference and Adherence: Despite benefits, some patient populations prefer alternative formulations or combination therapies, impacting market share.

• Regulatory Variability: Regulatory standards differ across countries, affecting the speed and scope of approvals for new indications or formulations.

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Projection and Future Outlook

Growth Projections (2023-2030)

The outlook for Glucophage XR remains optimistic, with projected CAGR of approximately 6-7% in sales revenue, driven primarily by increasing global diabetes prevalence and demand for improved-tolerability formulations.

Market Penetration Strategies

• Expansion in Emerging Markets: Manufacturers are investing in local manufacturing and pricing strategies to capture burgeoning diabetes treatment needs in India, China, and Africa.

• Combination Therapies: Development of fixed-dose combinations integrating Glucophage XR with newer antidiabetics, such as SGLT2 inhibitors and GLP-1 receptor agonists, are anticipated to open new market segments.

• Digital Health Integration: Incorporating digital adherence tools and remote monitoring technologies can augment patient engagement and adherence, indirectly boosting Glucophage XR's market share.

Innovative Development Trajectories

• Formulation Enhancements: Efforts to optimize bioavailability and reduce gastrointestinal side effects may improve compliance.

• Pharmacogenomics: Customized therapy based on genetic profiles may refine patient selection, potentially enhancing efficacy and minimizing adverse effects.

• New Indications and Label Extensions: Evidence generation for non-glycemic indications like NAFLD, cancer adjunct therapy, and aging-related metabolic decline could extend market applicability.

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Key Takeaways

• Robust Clinical Evidence: Ongoing and completed trials reinforce Glucophage XR’s safety and wider therapeutic potential, paving the way for broader indication approvals.

• Market Growth Driven by Rising Diabetes Burden: The global diabetic population, especially in emerging markets, fuels sustained demand, with extended-release formulations favored for their improved adherence profile.

• Competitive and Pricing Dynamics: Patent expiries and generic competition necessitate strategic positioning, including formulation innovation and combination therapies.

• Future Opportunities: Digital health integration and new therapeutic indications represent significant avenues for expansion, potentially elevating Glucophage XR’s market trajectory.

• Regulatory Landscape: Divergent international standards require tailored regulatory strategies to maximize global market penetration.

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FAQs

1. How does Glucophage XR differ from immediate-release metformin?
Glucophage XR offers a once-daily extended-release formulation designed to improve gastrointestinal tolerability and enhance patient adherence compared to immediate-release metformin, which often requires multiple doses daily.

2. What are the safety considerations associated with Glucophage XR?
Long-term and clinical data confirm its safety, with gastrointestinal disturbances being the most common side effects. Rare risks include lactic acidosis, particularly in patients with renal impairment, necessitating careful patient selection and monitoring.

3. Are there ongoing clinical studies looking at new indications for Glucophage XR?
Yes. Studies are exploring its role in preventing type 2 diabetes, treating NAFLD, and possibly supporting weight management and cardiovascular health, with preliminary data suggesting promising outcomes.

4. How does patent expiration impact the market for Glucophage XR?
Patent expiration leads to increased generic competition, reducing prices and potentially diminishing market share for the branded product. However, formulations with unique features or combination therapies can maintain competitive advantage.

5. What future developments could influence Glucophage XR’s market trajectory?
Advancements in pharmacogenomics, digital health integrations, combination therapies, and expanding indications—especially in prediabetic and non-diabetic metabolic disorders—could significantly bolster its market presence.

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References

[1] UKPDS 34, "Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes," UK Prospective Diabetes Study Group, Lancet, 1998.

[2] Market Watch, "Global Diabetes Drugs Market Size & Trends," 2022.

[3] IMS Health, "Prescription Data on Metformin Formulations," 2022.

[4] International Diabetes Federation, "IDF Diabetes Atlas," 2022.

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This comprehensive review underscores the resilient position of Glucophage XR in the evolving landscape of diabetes management, supported by robust clinical data, market growth, and strategic development pathways.