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
-

Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-05-12
Last Posted Date
2012-01-19
Lead Sponsor
Mount Sinai Hospital, Canada
Target Recruit Count
39
Registration Number
NCT00897884
Locations
🇨🇦

Princess Margaret Hospital, Toronto, Ontario, Canada

🇨🇦

Mount Sinai Hospital, Toronto, Ontario, Canada

Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-05-04
Last Posted Date
2017-11-17
Lead Sponsor
The Hospital for Sick Children
Target Recruit Count
9
Registration Number
NCT00892073
Locations
🇨🇦

The Hospital for Sick Children, Toronto, Ontario, Canada

Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

First Posted Date
2009-04-21
Last Posted Date
2017-05-23
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
313
Registration Number
NCT00885352

Metformin and Gestational Diabetes in High-risk Patients: a RCTs

First Posted Date
2009-04-17
Last Posted Date
2013-04-08
Lead Sponsor
University Magna Graecia
Target Recruit Count
80
Registration Number
NCT00883259
Locations
🇮🇹

Pugliese Hospital, Catanzaro, Catanzaro, CZ, Italy

🇮🇹

"Pugliese" Hospital, Catanzaro, Italy

🇮🇹

University of Catanzaro, Italy, Catanzaro, Italy

A Study of Pre-operative Metformin in Prostate Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2009-04-15
Last Posted Date
2012-06-19
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
24
Registration Number
NCT00881725
Locations
🇨🇦

University Health Network, Toronto, Ontario, Canada

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

First Posted Date
2009-04-15
Last Posted Date
2014-06-16
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
660
Registration Number
NCT00881530
Locations
🇺🇸

1245.24.101006 Boehringer Ingelheim Investigational Site, Wadsworth, Ohio, United States

🇺🇸

1245.24.101024 Boehringer Ingelheim Investigational Site, St. Cloud, Florida, United States

🇺🇸

1245.24.101015 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

and more 134 locations

A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-03-30
Last Posted Date
2023-11-18
Lead Sponsor
Response Pharmaceuticals
Target Recruit Count
82
Registration Number
NCT00871936

A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)

First Posted Date
2009-03-25
Last Posted Date
2018-09-10
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
118
Registration Number
NCT00868790

Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

First Posted Date
2009-03-12
Last Posted Date
2020-12-29
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1988
Registration Number
NCT00860288
Locations
🇰🇷

Ajou university hospital, Suwon, Korea, Republic of

🇱🇻

Daugavpils Regional Hospital, Daugavpils, Latvia

🇱🇻

Talsi Clinical Hospital, Talsi, Latvia

and more 180 locations

Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-03-09
Last Posted Date
2012-01-11
Lead Sponsor
GWT-TUD GmbH
Target Recruit Count
96
Registration Number
NCT00857870
Locations
🇩🇪

GWT -TUD, Center for Clinical Studies, Dresden, Germany

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