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

The Effect of Adding Metformin to the Treatment of Hepatitis C

Phase 4

Completed

Conditions: Hepatitis C

Interventions: Drug: Metformin
Drug: pegylated interferon
Drug: Ribavirin

First Posted Date: 2007-11-20

Last Posted Date: 2015-04-06

Lead Sponsor: Tehran University of Medical Sciences

Target Recruit Count: 140

Registration Number: NCT00560690

Locations: 🇮🇷
Shariati Hospital, Tehran, Iran, Islamic Republic of

Drug Interaction With Metformin

Phase 1

Completed

Conditions: Healthy Male and Female Subjects

Interventions: Drug: Dapagliflozin
Drug: Metformin
Drug: Dapagliflozin + Metformin

First Posted Date: 2007-10-19

Last Posted Date: 2016-12-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 18

Registration Number: NCT00546741

Locations: 🇺🇸
Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

Phase 4

Completed

Conditions: Impaired Glucose Tolerance

Interventions: Drug: Exenatide
Drug: Metformin

First Posted Date: 2007-10-19

Last Posted Date: 2013-11-08

Lead Sponsor: St. Paul Heart Clinic

Target Recruit Count: 50

Registration Number: NCT00546728

Locations: 🇺🇸
International Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, United States
🇺🇸
St. Paul Heart Clinic, St. Paul, Minnesota, United States

Treatment Insulin Resistence in HCV G-1 Patient

Phase 4

Completed

Conditions: Chronic Hepatitis C

Interventions: Other: Placebo of metformine
Drug: Metformine

First Posted Date: 2007-10-19

Last Posted Date: 2007-10-19

Lead Sponsor: Valme University Hospital

Target Recruit Count: 126

Registration Number: NCT00546442

Locations: 🇪🇸
Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
🇪🇸
Hospital de Leon, Leon, Spain
🇪🇸
Hospital del Mar, Barcelona, Spain

and more 16 locations

Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients

Phase 2

Conditions: Type 2 Diabetes

Interventions: Drug: benfluorex
Drug: metformin

First Posted Date: 2007-10-16

Last Posted Date: 2008-05-22

Lead Sponsor: Air Force Military Medical University, China

Target Recruit Count: 240

Registration Number: NCT00544518

Locations: 🇨🇳
XiJing hospital of Fourth Military Medical University, Xi'an, Shanxi, China

Physical Inactivity and Insulin Resistance in Skeletal Muscle.

Not Applicable

Withdrawn

Conditions: Metabolic Syndrome X
Insulin Resistance
Hypertension
Hypercholesterolemia
Obesity

Interventions: Behavioral: Exercise
Drug: Metformin

First Posted Date: 2007-09-27

Last Posted Date: 2021-05-04

Lead Sponsor: University of Kansas Medical Center

Registration Number: NCT00536211

Locations: 🇺🇸
Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Dapagliflozin
Drug: Placebo
Drug: Metformin

First Posted Date: 2007-09-12

Last Posted Date: 2015-10-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 915

Registration Number: NCT00528879

Locations: 🇺🇸
Clinical Research Advantage / Desert Clinical Res, Llc, Tempe, Arizona, United States
🇺🇸
Raikhel, Marina, Torrance, California, United States
🇺🇸
Office Of Dr. Gray, Spokane, Washington, United States

and more 26 locations

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Dapagliflozin
Drug: Dapagliflozin placebo
Drug: Metformin

First Posted Date: 2007-09-12

Last Posted Date: 2015-10-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 1067

Registration Number: NCT00528372

Locations: 🇺🇸
Banksville Medical, Pc, Pittsburgh, Pennsylvania, United States
🇺🇸
Ritchken & First M.D.'S, San Diego, California, United States
🇺🇸
Village Family Practice, Houston, Texas, United States

and more 36 locations