CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE
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505(b)(2) Clinical Trials for Metformin Hydrochloride
| 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). |
| 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). |
| New Combination | NCT05641337 ↗ | Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes | Recruiting | Huashan Hospital | Phase 3 | 2022-10-01 | Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes. |
| New Dosage | NCT06083675 ↗ | Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes | Withdrawn | Novo Nordisk A/S | Phase 3 | 2024-01-26 | This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. |
| New Formulation | NCT06942390 ↗ | Topical Metformin Versus Topical Ketotifen in Melasma Treatment | NOT_YET_RECRUITING | Assiut University | PHASE2 | 2025-06-01 | The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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 | >Sponsor | >Phase | >Start Date | >Summary |
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