Metformin

Generic Name: Metformin

Brand Names: Actoplus Met, Avandamet, Fortamet, Glucophage, Glucovance, Glumetza, Glycon, Invokamet, Janumet, Jentadueto, Kazano, Kombiglyze, Komboglyze, Qternmet, Riomet, Segluromet, Synjardy, Trijardy, Velmetia, Xigduo

Drug Type: Small Molecule

Chemical Formula: C_₄H_₁₁N_₅

CAS Number: 657-24-9

Unique Ingredient Identifier: 9100L32L2N

Background: Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes.

Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes.

Metformin was first approved in Canada in 1972, and received subsequent FDA approval in the US in 1995.

Indication: Metformin immediate-release formulations

Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years old with type 2 diabetes mellitus.

Metformin extended-release tablet (XR)

The extended-release formulation of metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Safety in children has not been determined to this date.

Metformin combination products

Metformin is a component of a variety of combination products with other anti-diabetic agents. It is indicated, along with diet and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus in combination with DPP-4 inhibitors (sitagliptin, linagliptin, alogliptin, or saxagliptin), in combination with SGLT2 inhibitors (canagliflozin, empagliflozin, ertugliflozin, or dapagliflozin), or in combination with pioglitazone.

Associated Conditions: Cardiovascular Mortality, End Stage Renal Disease (ESRD), Hospitalizations, Polycystic Ovarian Syndrome (PCOS), Type 2 Diabetes Mellitus, Decreased estimated glomerular filtration rate

Associated Therapies: -

Clinical Trials

Metformin in Castration-Resistant Prostate Cancer

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Metformin

First Posted Date: 2010-10-05

Last Posted Date: 2017-05-15

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 21

Registration Number: NCT01215032

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Metformin Combined With Chemotherapy for Pancreatic Cancer

Phase 2

Completed

Conditions: Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer

Interventions: Drug: gemcitabine
Drug: erlotinib
Drug: placebo
Drug: metformin

First Posted Date: 2010-09-29

Last Posted Date: 2021-04-21

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 120

Registration Number: NCT01210911

Locations: 🇳🇱
Academic Medical Center, Amsterdam, Netherlands

Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization

Phase 4

Terminated

Conditions: Infertility
PCOS
Prognosis for Poor Response

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2010-09-24

Last Posted Date: 2011-05-24

Lead Sponsor: University Magna Graecia

Target Recruit Count: 88

Registration Number: NCT01208740

Locations: 🇮🇹
Pugliese" Hospital, Catanzaro, Italy

Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients

Phase 4

Completed

Conditions: Amenorrhea

Interventions: Drug: metformin

First Posted Date: 2010-09-21

Last Posted Date: 2010-09-21

Lead Sponsor: Central South University

Target Recruit Count: 84

Registration Number: NCT01206153

Locations: 🇨🇳
Institute of Mental Health of The Second Xiangya Hospital, Central South University, Changsha, Hunan, China

Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer

Early Phase 1

Completed

Conditions: Endometrial Cancer

Interventions: Drug: Metformin

First Posted Date: 2010-09-20

Last Posted Date: 2017-06-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 21

Registration Number: NCT01205672

Locations: 🇺🇸
Lyndon B. Johnson General Hospital, Houston, Texas, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Comprehensive Add on Study in Japan

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin
Drug: Metformin

First Posted Date: 2010-09-17

Last Posted Date: 2014-03-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 574

Registration Number: NCT01204294

Locations: 🇯🇵
1218.78.037 Boehringer Ingelheim Investigational Site, Higashi Osaka, Osaka, Japan
🇯🇵
1218.78.026 Boehringer Ingelheim Investigational Site, Kasugai, Aichi, Japan
🇯🇵
1218.78.038 Boehringer Ingelheim Investigational Site, Kawachinagano, Osaka, Japan

and more 40 locations

Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Phase 4

Completed

Conditions: Patients With Glucocorticoid Treatment

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2010-08-24

Last Posted Date: 2016-04-28

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 29

Registration Number: NCT01187849

Locations: 🇨🇭
University Hospital Basel, Basel, Basel-Stadt, Switzerland

Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: insulin glargine
Other: Standard glycemic care
Drug: metformin
Drug: acarbose
Behavioral: lifestyle therapy

First Posted Date: 2010-08-13

Last Posted Date: 2020-05-21

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 83

Registration Number: NCT01181674

Locations: 🇨🇦
McMaster University Medical Centre, Diabetes Care and Research Program, Hamilton, Ontario, Canada

Metformin for Weight Loss in Schizophrenia

Not Applicable

Terminated

Conditions: Schizophrenia
Obesity

Interventions: Drug: Metformin

First Posted Date: 2010-08-09

Last Posted Date: 2017-09-01

Lead Sponsor: Nathan Kline Institute for Psychiatric Research

Target Recruit Count: 12

Registration Number: NCT01177709

Locations: 🇺🇸
Manhatan Psychiatric Center, New York, New York, United States

Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Liraglutide
Device: Pen auto-injector
Device: Pre-filled pen injector
Drug: Metformin

First Posted Date: 2010-08-04

Last Posted Date: 2016-11-28

Lead Sponsor: Sanofi

Target Recruit Count: 148

Registration Number: NCT01175473

Locations: 🇩🇪
Sanofi-Aventis Investigational Site Number 276004, Kiel, Germany
🇩🇪
Sanofi-Aventis Investigational Site Number 276002, Mainz, Germany
🇩🇪
Sanofi-Aventis Investigational Site Number 276006, Berlin, Germany

and more 4 locations

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