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

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Liraglutide
Drug: Insulin glargine
Drug: Metformin

First Posted Date: 2010-05-05

Last Posted Date: 2014-04-11

Lead Sponsor: Sanofi

Target Recruit Count: 978

Registration Number: NCT01117350

Locations: 🇺🇸
Investigational Site Number 840026, Longmont, Colorado, United States
🇺🇸
Investigational Site Number 840007, Dallas, Texas, United States
🇺🇸
Investigational Site Number 840020, Uniontown, Pennsylvania, United States

and more 133 locations

A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: ipragliflozin
Drug: Metformin

First Posted Date: 2010-05-05

Last Posted Date: 2024-11-06

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 343

Registration Number: NCT01117584

Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: BMS-823778
Drug: Placebo
Drug: Metformin

First Posted Date: 2010-04-28

Last Posted Date: 2015-10-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 62

Registration Number: NCT01111955

Locations: 🇺🇸
Capital Clinical Reserch Center, Olympia, Washington, United States
🇺🇸
Farid Marquez, Md, Hialeah, Florida, United States
🇨🇦
Local Institution, Quebec, Canada

and more 1 locations

The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Canagliflozin
Drug: Metformin
Drug: Sitagliptin
Drug: Pioglitazone

First Posted Date: 2010-04-20

Last Posted Date: 2013-07-15

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 344

Registration Number: NCT01106690

The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Canagliflozin
Drug: Placebo
Drug: Metformin
Drug: Sulphonylruea

First Posted Date: 2010-04-20

Last Posted Date: 2013-06-20

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 469

Registration Number: NCT01106625

A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: metformin hydrochloride
Other: placebo

First Posted Date: 2010-04-12

Last Posted Date: 2023-09-13

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 3649

Registration Number: NCT01101438

Locations: 🇺🇸
Kaiser Permanente-San Rafael, San Rafael, California, United States
🇨🇦
The Vitalite Health Network - Dr. Leon Richard, Moncton, New Brunswick, Canada
🇺🇸
Kaiser Permanente-Vallejo, Vallejo, California, United States

and more 340 locations