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.

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	27
Diabetes Mellitus, Type 2	22

Condition MeSH

Condition MeSH for Glucophage Xr
Intervention	Trials
Diabetes Mellitus	94
Diabetes Mellitus, Type 2	81
Insulin Resistance	23
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	98
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
Phase 4	66
Phase 3	49
Phase 2/Phase 3	12

Clinical Trial Status

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

Clinical Trials, Market Analysis, and Projections for GLUCOPHAGE XR

Last updated: January 1, 2025

Introduction to GLUCOPHAGE XR

GLUCOPHAGE XR, an extended-release formulation of metformin hydrochloride, is a widely used medication for managing type 2 diabetes mellitus. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Bioequivalence Studies

A recent clinical study aimed to investigate the bioequivalence of a new formulation of GLUCOPHAGE XR, known as GLUCOPHAGE XR Reduced Mass (RM) tablet. This study compared the pharmacokinetic profiles of the new formulation with the current marketed GLUCOPHAGE XR tablet under both fasted and fed conditions.

• Objectives and Endpoints: The primary objective was to demonstrate the bioequivalence of the new GLUCOPHAGE XR RM tablet and the current GLUCOPHAGE XR tablet in terms of area under the plasma concentration-time curve (AUClast) and maximum plasma concentration (Cmax) of metformin[1].
• Study Design: The study employed a 2-way crossover design involving 82 participants, with two parts: one under fasted conditions and the other under fed conditions. Each part included a wash-out period of at least 7 days between the two treatment periods[1].

Safety and Tolerability

In addition to bioequivalence, the study also evaluated the safety and tolerability of the new formulation.

• Secondary Objectives: These included assessing treatment-emergent adverse events (TEAEs), concomitant medications, laboratory safety tests, cardiac safety monitoring, and vital signs[1].

Market Analysis

Current Market Status

The global metformin market, which includes GLUCOPHAGE XR, was valued at USD 4,028 million in 2022. This market is expected to grow significantly, reaching USD 6,420.02 million by 2030[3].

Product Types and Distribution

• Product Types: The market is segmented into standard-release tablets and slow-release tablets, with GLUCOPHAGE XR falling under the slow-release category. Dosage types include 500mg, 750mg, 850mg, and 1g[3].
• Distribution Channels: The drug is distributed through hospital pharmacies, retail pharmacies, online pharmacies, and other channels[3].

Competitive Landscape

The diabetes management market is highly competitive, with various products and formulations vying for market share.

• Biosimilars and Generics: The introduction of biosimilars and generics, such as Sanofi's unbranded insulin glargine, which is about 60% cheaper than Lantus, is changing the market dynamics. CVS Caremark has also shifted its coverage to favor newer products and generics, including an insulin infusion system[2].

Market Projections

Growth Drivers

• Increasing Incidence of Diabetes: The rising incidence of diabetes globally is a significant driver for the growth of the metformin market. The global insulin glargine market, for example, is expected to grow from $5.45 billion in 2024 to $8.43 billion in 2031[2].
• Biosimilars: The increasing adoption of biosimilars is expected to boost market volume. However, payer controls and limited coverage by some Medicare payers may affect the uptake of these newer products[2].

Market Trends

• Patient Compliance: Formulations like GLUCOPHAGE XR Reduced Mass, designed to be easier to swallow, are expected to improve patient compliance and thus contribute to market growth[1].
• Regulatory Environment: Regulatory approvals and bridging studies, such as the one that bridged Riomet ER to GLUCOPHAGE XR, play a crucial role in expanding the market for metformin formulations[4].

Dosage and Administration

Adult Dosage

• Starting Dose: The recommended starting dose for GLUCOPHAGE XR is 500 mg orally once daily with the evening meal. The dose can be increased in increments of 500 mg weekly based on glycemic control and tolerability, up to a maximum of 2000 mg per day[5].

Special Considerations

• Renal Impairment: GLUCOPHAGE XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m^2. Initiation in patients with an eGFR between 30-45 mL/minute/1.73 m^2 is not recommended[5].

Key Takeaways

• Bioequivalence: Recent clinical trials aim to establish the bioequivalence of new formulations like GLUCOPHAGE XR Reduced Mass to the current marketed GLUCOPHAGE XR.
• Market Growth: The global metformin market is projected to grow significantly due to the increasing incidence of diabetes and the adoption of biosimilars.
• Patient Compliance: New formulations designed for easier swallowability are expected to improve patient compliance.
• Regulatory Environment: Bridging studies and regulatory approvals are crucial for expanding the market for metformin formulations.

FAQs

What is the primary objective of the recent clinical trial for GLUCOPHAGE XR Reduced Mass?

The primary objective is to demonstrate the bioequivalence of the new GLUCOPHAGE XR Reduced Mass tablet and the current GLUCOPHAGE XR tablet in terms of AUClast and Cmax of metformin under fasted and fed conditions[1].

How is the global metformin market expected to grow?

The global metformin market is expected to grow from USD 4,028 million in 2022 to USD 6,420.02 million by 2030[3].

What are the key drivers for the growth of the metformin market?

Key drivers include the increasing incidence of diabetes and the adoption of biosimilars and generics[2][3].

What are the special considerations for administering GLUCOPHAGE XR in patients with renal impairment?

GLUCOPHAGE XR is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m^2, and initiation is not recommended in patients with an eGFR between 30-45 mL/minute/1.73 m^2[5].

How does the new GLUCOPHAGE XR Reduced Mass formulation differ from the current GLUCOPHAGE XR?

The new formulation contains fewer excipients and is designed to be easier to swallow, potentially improving patient compliance[1].

Sources

1. Clinical Study Protocol - ClinicalTrials.gov: "Glucophage XR Reduced Mass (RM) tablet bioequivalence study"[1].
2. CVS Caremark Makes Changes in Diabetes Coverage for 2025: "Managed Healthcare Executive"[2].
3. Metformin Market Size, Share, Statistics & Industry Forecast By 2030: "Data Bridge Market Research"[3].
4. Clinical Review(s) - accessdata.fda.gov: "Riomet ER drug product bridged to Glucophage XR via bioequivalence study"[4].
5. GLUCOPHAGE and GLUCOPHAGE XR - accessdata.fda.gov: "Label and dosage information for Glucophage and Glucophage XR"[5].