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.
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.

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

Last updated: April 27, 2026

Glucophage XR (metformin HCl ER): Clinical Trials Update, Market Analysis, and Projection

What is Glucophage XR and how is it positioned clinically?

Glucophage XR is an extended-release (ER) formulation of metformin hydrochloride. It is used for type 2 diabetes mellitus (T2D) to improve glycemic control and is commonly prescribed as a long-term therapy in chronic disease management.

Metformin is a foundational, first-line therapy in T2D and is widely used due to low cost, extensive clinical use, and a long history of safety data. The ER formulation targets once-daily or less frequent dosing compared with immediate-release metformin, improving adherence for some patients.

Core product framing (drug class and formulation)

• Active ingredient: metformin HCl
• Formulation: extended-release (XR)
• Indication: glycemic control in T2D (clinical practice standard)
• Therapeutic role: chronic background therapy, typically early-line in T2D pathways (guideline-supported)

What do the current clinical trials landscape signals show for Glucophage XR?

Public clinical activity specific to “Glucophage XR” as a named branded product tends to be limited relative to trials that evaluate:

• metformin in general,
• class-level regimens combined with newer agents, or
• formulation/bioequivalence work.

In practice, “clinical trials update” for a mature brand like Glucophage XR usually appears through: 1) trials that evaluate metformin-containing regimens (often metformin is the comparator or background drug rather than a study drug brand name), and
2) bioequivalence or formulation studies for ER metformin products rather than brand-level efficacy trials.

Implication for investors and R&D

• Expect incremental trial signals (formulation, endpoints in specific populations, combination regimens) rather than major new efficacy claims unique to Glucophage XR itself.
• Market growth for Glucophage XR is more likely driven by T2D epidemiology, payer behavior, guideline adherence, and competitive dynamics in oral generics rather than new branded clinical outcomes.

What ongoing trial types are most relevant to metformin XR products?

For mature metformin ER brands, the most decision-relevant clinical trial signals typically include:

• Combination trials where metformin ER is background therapy and newer agents show incremental HbA1c change or durability.
• Real-world effectiveness and safety studies focusing on GI tolerability, adherence, and persistence in ER versus IR metformin.
• Subgroup and adherence-focused research in high-dropout populations where once-daily ER dosing can shift outcomes.
• Regulatory and formulation studies tied to manufacturing changes, generics/biosimilars of metformin ER, or comparative PK/BE.

These signals do not usually translate into new FDA labeling for metformin ER brands, but they influence prescriber preference and payer prior authorization behavior.

Market Analysis: Where Glucophage XR sits in the T2D oral market

Metformin ER operates inside a large and mature T2D market dominated by:

• generic metformin (IR and ER),
• increasing competition from SGLT2 inhibitors and GLP-1 receptor agonists for later-line escalation, and
• fixed-dose combination products that include metformin plus add-on mechanisms.

Because metformin is off-patent in most markets, “brand-specific” market share usually depends on:

• formulary inclusion,
• copay tiers and rebates,
• substitution rules (automatic generic substitution),
• and product-specific differentiation at the pharmacy level (ER dosing preference, tablet formulation).

Commercial drivers that support sustained demand

For Glucophage XR specifically, the demand profile typically tracks:

• T2D prevalence and diagnosis rates (bigger patient pool),
• guideline adherence to metformin early in therapy,
• payer cost containment through metformin-based regimens, and
• tolerability and adherence advantages that ER formulations can offer vs IR in real-world settings.

Commercial risks

The principal risks to Glucophage XR’s commercial trajectory are:

• generic substitution intensity in oral antidiabetics,
• therapeutic migration toward combination injectables (and oral agents in later lines),
• formulary restriction or tier downgrades as payers rationalize generics,
• and pricing pressure across the metformin ER segment.

Market projection approach for a mature, off-patent brand

A credible forward view needs to align with the mechanics of mature branded generics:

• Growth is not driven by new clinical claims.
• Growth is driven by patient counts, adherence behaviors, formulary position, and pricing/rebate dynamics.
• If Glucophage XR remains on key formularies and holds ER preference, it can sustain share even while absolute branded growth is modest.

Below is a projection framework tailored to decision-making without relying on “brand-specific” proprietary sales numbers.

Projection: base case scenario (qualitative, decision-grade)

• Volume: grows in line with T2D patient population growth and persistence on metformin therapy.
• Mix: shifts toward ER when tolerability and dosing convenience support adherence.
• Price: declines gradually in nominal terms due to competitive generic pressure, offset by rebate structures where applicable.
• Net revenue: grows slowly or flattens versus patient growth depending on formulary and rebate outcomes.

Projection: downside scenario

• Strong generic substitution and formulary restrictions reduce share.
• Increased migration to non-metformin add-ons decreases metformin discontinuation rates but reduces intensity of metformin initiation in newly treated patients.
• Revenue tracks below patient growth due to higher discounting and lower ER share.

Projection: upside scenario

• Payer tightening of newer drug spend increases metformin-based step therapy uptake.
• ER tolerability wins translate into better persistence, raising ER share within metformin.
• Glucophage XR keeps favorable formulary positioning across large payers.

Competitive landscape: ER metformin versus alternative mechanisms

Even if ER metformin remains clinically used, the T2D market redistributes spend toward newer agents. The net effect on metformin ER brands is:

• volume resilience in appropriate patients,
• pricing and share pressure from generics and fixed-dose combinations,
• and indirect headwinds as prescribers escalate therapy earlier in some populations.

Operational outlook for R&D and business planning

For a mature molecule like metformin, the R&D value proposition typically shifts from “new drug development” to:

• improving formulation tolerability and adherence,
• expanding evidence in special populations (renal function, older adults, adherence-challenged cohorts),
• and evaluating metformin ER in combination strategies (real-world and pragmatic trials).

Key Takeaways

• Glucophage XR is a long-established metformin extended-release option for T2D chronic glycemic control.
• Branded “clinical trial updates” are unlikely to resemble late-stage, brand-defining efficacy programs; relevant signals usually come from metformin-class regimen studies, adherence and tolerability work, and formulation-level evidence.
• Market direction is mainly driven by T2D prevalence, persistence on metformin therapy, and formulary positioning versus generic substitution.
• Expect slow-to-flat revenue behavior under generic competitive pressure, with upside tied to ER mix retention and payer favorability.

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FAQs

1) Is Glucophage XR still clinically used as a first-line therapy?
Yes. In standard clinical practice and guideline-driven care, metformin remains a foundational early-line treatment in T2D, and ER formulations support tolerability and adherence for some patients.

2) What types of trials are most likely to affect metformin XR brands?
Regimen combination studies where metformin ER is background therapy, real-world effectiveness and persistence research, and tolerability/adherence studies comparing ER versus IR.

3) What is the biggest commercial risk for Glucophage XR?
Generic substitution and formulary tier pressure from other metformin ER products and lower-cost alternatives.

4) How does the rise of GLP-1 and SGLT2 impact metformin XR?
It can reduce metformin’s relative share in later-line treatment escalation, though it does not eliminate the role of metformin as a common backbone therapy.

5) What is the most important factor for future market performance?
Whether payers and formularies keep Glucophage XR favored for ER dosing within metformin-based regimens, supporting adherence-driven persistence and mix.

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References

[1] FDA. Glucophage XR (metformin hydrochloride extended-release) prescribing information. U.S. Food and Drug Administration.
[2] American Diabetes Association. Standards of Care in Diabetes (latest edition).
[3] Centers for Disease Control and Prevention (CDC). National Diabetes Statistics Report (latest edition).