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Last Updated: January 24, 2020

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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 Not yet recruiting Tess Wuyts Phase 3 2019-04-01 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)
>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.
NCT00004992 Diabetes Prevention Program Completed Office of Research on Women's Health (ORWH) 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 2 414
Type 2 Diabetes Mellitus 355
Type 2 Diabetes 216
Diabetes 150
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Condition MeSH

Condition MeSH for Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 1146
Diabetes Mellitus, Type 2 1097
Polycystic Ovary Syndrome 136
Syndrome 116
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Clinical Trial Locations for Metformin Hydrochloride

Trials by Country

Trials by Country for Metformin Hydrochloride
Location Trials
Canada 612
Japan 87
Slovakia 77
Czech Republic 77
Netherlands 74
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Trials by US State

Trials by US State for Metformin Hydrochloride
Location Trials
Texas 381
California 374
Florida 321
Ohio 252
North Carolina 243
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Clinical Trial Progress for Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 517
Phase 3 536
Phase 2/Phase 3 49
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Clinical Trial Status

Clinical Trial Status for Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 1160
Recruiting 396
Not yet recruiting 221
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Clinical Trial Sponsors for Metformin Hydrochloride

Sponsor Name

Sponsor Name for Metformin Hydrochloride
Sponsor Trials
AstraZeneca 146
Novo Nordisk A/S 127
Merck Sharp & Dohme Corp. 110
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Sponsor Type

Sponsor Type for Metformin Hydrochloride
Sponsor Trials
Other 1615
Industry 1353
NIH 123
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