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

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: metformin placebo
Drug: metformin
Drug: linagliptin
Drug: linagliptin placebo

First Posted Date: 2011-09-22

Last Posted Date: 2014-11-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 689

Registration Number: NCT01438814

Locations: 🇧🇪
1218.60.32001 Boehringer Ingelheim Investigational Site, Genk, Belgium
🇧🇪
1218.60.32005 Boehringer Ingelheim Investigational Site, Ham, Belgium
🇧🇪
1218.60.32004 Boehringer Ingelheim Investigational Site, Natoye, Belgium

and more 87 locations

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Phase 2

Completed

Conditions: Stage IIB Prostate Cancer
Stage I Prostate Cancer
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IIA Prostate Cancer

Interventions: Other: placebo
Drug: metformin hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2011-09-14

Last Posted Date: 2018-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT01433913

Locations: 🇺🇸
Arizona Cancer Center - Tucson, Tucson, Arizona, United States
🇺🇸
University of Arizona Health Sciences Center, Tucson, Arizona, United States
🇺🇸
University of Southern California/Norris Cancer Center, Los Angeles, California, United States

Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

Phase 1

Active, not recruiting

Conditions: Glioblastoma
Gliosarcoma
Supratentorial Glioblastoma

Interventions: Drug: Memantine Hydrochloride
Drug: Mefloquine
Drug: Metformin Hydrochloride
Drug: Temozolomide

First Posted Date: 2011-09-08

Last Posted Date: 2024-07-29

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 144

Registration Number: NCT01430351

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients

Phase 4

Completed

Conditions: Endothelial Dysfunction
Diabetes Mellitus

Interventions: Drug: Glimepiride/metformin
Drug: Metformin

First Posted Date: 2011-09-07

Last Posted Date: 2011-09-07

Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Target Recruit Count: 16

Registration Number: NCT01429818

Locations: 🇲🇽
Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México, Mexico city, Distrito Federal, Mexico

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome
Hyperandrogenism

Interventions: Drug: Metformin
Drug: Progesterone
Drug: estrace

First Posted Date: 2011-09-01

Last Posted Date: 2021-01-08

Lead Sponsor: University of Virginia

Target Recruit Count: 25

Registration Number: NCT01427595

Locations: 🇺🇸
Center for Research in Reproduction, University of Virginia, Charlottesville, Virginia, United States

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: LC15-0444
Drug: Metformin
Drug: LC15-0444+Metformin

First Posted Date: 2011-08-31

Last Posted Date: 2011-12-30

Lead Sponsor: LG Life Sciences

Target Recruit Count: 30

Registration Number: NCT01426399

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Liraglutide and Heart Failure in Type 2 Diabetes

Phase 2

Completed

Conditions: Congestive Heart Failure
Type 2 Diabetes Mellitus

Interventions: Drug: liraglutide
Drug: glimepiride
Drug: Metformin

First Posted Date: 2011-08-30

Last Posted Date: 2016-09-01

Lead Sponsor: Thomas Nystrom

Target Recruit Count: 62

Registration Number: NCT01425580

Locations: 🇸🇪
Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm, Sweden
🇸🇪
Karolinska Institutet, Division of Internal Medicine Södersjukhuset AB, Stockholm, Sweden

Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea

Not Applicable

Withdrawn

Conditions: Weight Gain
Amenorrhea

Interventions: Other: Starch tablets
Drug: Metformin

First Posted Date: 2011-08-26

Last Posted Date: 2012-08-02

Lead Sponsor: Central South University

Registration Number: NCT01423487

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

Effect of Metformin on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess

Early Phase 1

Recruiting

Conditions: Obesity
Hyperandrogenemia
Polycystic Ovary Syndrome

Interventions: Drug: Metformin

First Posted Date: 2011-08-24

Last Posted Date: 2023-10-27

Lead Sponsor: University of Virginia

Target Recruit Count: 20

Registration Number: NCT01422746

Locations: 🇺🇸
University of Virginia Center for Research in Reproduction, Charlottesville, Virginia, United States

Adipokines in Obese Adolescents With Insulin Resistance

Phase 4

Completed

Conditions: Obesity

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2011-08-05

Last Posted Date: 2012-04-27

Lead Sponsor: Hospital Regional de Alta Especialidad del Bajio

Target Recruit Count: 31

Registration Number: NCT01410604

Locations: 🇲🇽
Hospital Regional de Alta Especialidad del Bajío, León, Guanajuato, Mexico
🇲🇽
Hospital Infantil de México Federico Gómez, México, Distrito Federal, Mexico

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