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Last Updated: February 25, 2021

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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.
NCT00004992 Diabetes Prevention Program Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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.
NCT00005104 Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Completed University of Virginia N/A 2000-01-01 OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
NCT00005104 Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome Completed National Center for Research Resources (NCRR) N/A 2000-01-01 OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
>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 2 428
Type 2 Diabetes Mellitus 360
Type 2 Diabetes 226
Diabetes 153
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Condition MeSH

Condition MeSH for Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 1185
Diabetes Mellitus, Type 2 1137
Polycystic Ovary Syndrome 140
Syndrome 123
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Clinical Trial Locations for Metformin Hydrochloride

Trials by Country

Trials by Country for Metformin Hydrochloride
Location Trials
Canada 613
Japan 87
Slovakia 79
Czech Republic 77
Denmark 76
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Trials by US State

Trials by US State for Metformin Hydrochloride
Location Trials
Texas 385
California 377
Florida 324
Ohio 255
North Carolina 244
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Clinical Trial Progress for Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 546
Phase 3 559
Phase 2/Phase 3 56
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Clinical Trial Status

Clinical Trial Status for Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 1168
Recruiting 422
Not yet recruiting 295
[disabled in preview] 356
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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 130
Merck Sharp & Dohme Corp. 112
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Sponsor Type

Sponsor Type for Metformin Hydrochloride
Sponsor Trials
Other 1755
Industry 1392
NIH 127
[disabled in preview] 21
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