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 and Gestational Diabetes in High-risk Patients: a RCTs

Phase 4

Conditions: Obesity
Polycystic Ovary Syndrome
Gestational Diabetes

Interventions: Drug: Metformin
Other: Placebo

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

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

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: BI 10773
Drug: Metformin
Drug: Sitagliptin

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 Study of Pre-operative Metformin in Prostate Cancer

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Metformin

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

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

Phase 2

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: SLx-4090
Other: Placebo
Drug: Metformin

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)

Phase 2

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: MK-3577
Drug: Placebo to MK-3577
Drug: Metformin
Drug: Placebo to Metformin

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

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Vildagliptin
Drug: Sitagliptin
Drug: Metformin
Drug: Placebo

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