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Last Updated: January 27, 2023

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.
>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 27
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Condition MeSH

Condition MeSH for Glucophage Xr
Intervention Trials
Diabetes Mellitus 94
Diabetes Mellitus, Type 2 81
Insulin Resistance 23
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Clinical Trial Locations for Glucophage Xr

Trials by Country

Trials by Country for Glucophage Xr
Location Trials
United States 453
China 97
Canada 41
India 25
United Kingdom 21
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Trials by US State

Trials by US State for Glucophage Xr
Location Trials
California 33
Texas 33
Ohio 21
New York 20
Pennsylvania 20
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Clinical Trial Progress for Glucophage Xr

Clinical Trial Phase

Clinical Trial Phase for Glucophage Xr
Clinical Trial Phase Trials
Phase 4 64
Phase 3 49
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Glucophage Xr
Clinical Trial Phase Trials
Completed 208
Unknown status 34
Recruiting 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 382
Industry 167
NIH 66
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