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 Reduces Left Ventricular Mass in Patients With Ischemic Heart Disease

Phase 4

Completed

Conditions: Left Ventriclar Mass

Interventions: Drug: placebo
Drug: Metformin

First Posted Date: 2013-06-17

Last Posted Date: 2015-08-18

Lead Sponsor: Wuhan General Hospital of Guangzhou Military Command

Target Recruit Count: 120

Registration Number: NCT01879293

Locations: 🇨🇳
Wuhan General Hospital, Wuhan, Hubei, China

Metformin at the Cellular Level and Dosing for Diabetes Mellitus (DM)

Not Applicable

Terminated

Conditions: Obesity
Diabetes
Pre-diabetes

Interventions: Drug: Metformin

First Posted Date: 2013-06-13

Last Posted Date: 2017-09-26

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 10

Registration Number: NCT01876992

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women

Phase 2

Completed

Conditions: Adenocarcinoma of the Endometrium

Interventions: Drug: Metformin

First Posted Date: 2013-06-13

Last Posted Date: 2017-10-25

Lead Sponsor: University of Arkansas

Target Recruit Count: 10

Registration Number: NCT01877564

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media

Not Applicable

Completed

Conditions: Diabetes Mellitus
Lactic Acidosis

Interventions: Drug: Metformin

First Posted Date: 2013-06-10

Last Posted Date: 2014-06-16

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Target Recruit Count: 166

Registration Number: NCT01873859

Locations: 🇮🇷
Cardiovascular research center, Modarres hospital., Tehran, Iran, Islamic Republic of

A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy

Phase 3

Completed

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: aleglitazar
Drug: placebo
Drug: metformin

First Posted Date: 2013-06-06

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 7

Registration Number: NCT01871415

Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus (T2DM)

Interventions: Drug: Vildagliptin
Drug: Metformin
Drug: sulfonylurea (SU)
Drug: Basal Insulin

First Posted Date: 2013-06-06

Last Posted Date: 2016-04-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 42

Registration Number: NCT01871558

Locations: 🇫🇷
Novartis Investigative Site, Valenciennes, France

Study of Metformin Pharmacogenetics in Twins

Phase 1

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin

First Posted Date: 2013-06-05

Last Posted Date: 2014-12-03

Lead Sponsor: University of Southern Denmark

Target Recruit Count: 34

Registration Number: NCT01869621

Locations: 🇩🇰
Clinical Pharmacology, Odense C, Denmark

The Metformin Active Surveillance Trial (MAST) Study

Phase 3

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2013-05-29

Last Posted Date: 2024-01-24

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 408

Registration Number: NCT01864096

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇨🇦
London Health Sciences Centre-Victoria Hospital, London, Ontario, Canada
🇨🇦
MUHC - Montreal General Hospital, Montreal, Quebec, Canada

and more 9 locations