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Last Updated: June 21, 2024

CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE


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505(b)(2) Clinical Trials for Metformin Hydrochloride

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 Combination NCT00151697 ↗ LANN-study: Lantus, Amaryl, Novorapid, Novomix Study Completed Rijnstate Hospital Phase 3 2005-05-01 Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
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).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Metformin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004992 ↗ Diabetes Prevention Program Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1996-07-01 The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
NCT00004992 ↗ Diabetes Prevention Program Completed National Institute on Aging (NIA) Phase 3 1996-07-01 The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
NCT00004992 ↗ Diabetes Prevention Program Completed National Institute on Minority Health and Health Disparities (NIMHD) Phase 3 1996-07-01 The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Metformin Hydrochloride

Condition Name

Condition Name for Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 452
Type 2 Diabetes Mellitus 385
Type 2 Diabetes 256
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Condition MeSH

Condition MeSH for Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 1264
Diabetes Mellitus, Type 2 1220
Polycystic Ovary Syndrome 159
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Clinical Trial Locations for Metformin Hydrochloride

Trials by Country

Trials by Country for Metformin Hydrochloride
Location Trials
Canada 749
Slovakia 94
Egypt 92
Taiwan 85
Denmark 84
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Trials by US State

Trials by US State for Metformin Hydrochloride
Location Trials
Texas 420
California 418
Florida 360
Ohio 278
North Carolina 274
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Clinical Trial Progress for Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 588
Phase 3 621
Phase 2/Phase 3 71
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Clinical Trial Status

Clinical Trial Status for Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 1593
Recruiting 243
Unknown status 215
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Clinical Trial Sponsors for Metformin Hydrochloride

Sponsor Name

Sponsor Name for Metformin Hydrochloride
Sponsor Trials
AstraZeneca 152
Novo Nordisk A/S 136
Eli Lilly and Company 115
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Sponsor Type

Sponsor Type for Metformin Hydrochloride
Sponsor Trials
Other 2164
Industry 1576
NIH 153
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