MedPath

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
C4H11N5
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
-

MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2007-06-05
Last Posted Date
2017-06-09
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1246
Registration Number
NCT00482729

A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

Phase 2
Completed
Conditions
Type II Diabetes Mellitus
Interventions
First Posted Date
2007-06-04
Last Posted Date
2017-04-04
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
555
Registration Number
NCT00481663

Dose-Range Finding Study for MK0893 (0893-008)

Phase 2
Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: MK0893
Drug: Metformin
Drug: Placebo to MK0893
Drug: Placebo to Metformin
First Posted Date
2007-05-28
Last Posted Date
2015-09-09
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
342
Registration Number
NCT00479466

Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial)

Phase 4
Completed
Conditions
Congestive Heart Failure
Insulin Resistance
Interventions
Drug: Metformin
Drug: Matched Placebo (Capsules)
First Posted Date
2007-05-16
Last Posted Date
2013-06-06
Lead Sponsor
University of Dundee
Target Recruit Count
62
Registration Number
NCT00473876
Locations
🇬🇧

Medicine and Therapeutics, Ninewells Hospital, Dundee, Scotland, United Kingdom

Treatment of Anovulatory Infertility in PCOS Patients

Phase 4
Completed
Conditions
Infertility
Polycystic Ovary Syndrome
Anovulation
First Posted Date
2007-05-10
Last Posted Date
2007-05-10
Lead Sponsor
University Magna Graecia
Target Recruit Count
80
Registration Number
NCT00471523
Locations
🇮🇹

"Pugliese Hospital", Catanzaro, CZ, Italy

Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

Phase 3
Terminated
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
Drug: inhaled human insulin
Drug: metformin
Drug: glimepiride
First Posted Date
2007-05-04
Last Posted Date
2017-03-01
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
174
Registration Number
NCT00469586
Locations
🇹🇷

Novo Nordisk Investigational Site, Konya, Turkey

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
First Posted Date
2007-05-04
Last Posted Date
2017-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
480
Registration Number
NCT00469092
Locations
🇸🇪

Novo Nordisk Investigational Site, Stockholm, Sweden

Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin

Phase 3
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Metformin
Drug: Placebo
First Posted Date
2007-04-27
Last Posted Date
2016-07-20
Lead Sponsor
Norwegian University of Science and Technology
Target Recruit Count
48
Registration Number
NCT00466622
Locations
🇳🇴

Dept. of Obstetrics and Gynecology, National Center for fetal Medicine, University Hospital of Trondheim, Trondheim, Norway

The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
First Posted Date
2007-04-20
Last Posted Date
2007-04-20
Lead Sponsor
Haydarpasa Numune State Hospital
Registration Number
NCT00463502

A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects

Phase 2
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: YM543
Drug: Metformin
Drug: Placebo
First Posted Date
2007-03-30
Last Posted Date
2008-10-16
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
97
Registration Number
NCT00454233
Locations
🇷🇺

4 Sites, Moscow, Russian Federation

🇷🇺

10 Sites, St. Petersburg, Russian Federation

© Copyright 2025. All Rights Reserved by MedPath