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

Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study

Phase 4

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2008-07-28

Last Posted Date: 2012-12-11

Lead Sponsor: Professor Naveed Sattar

Target Recruit Count: 173

Registration Number: NCT00723307

Locations: 🇬🇧
Glasgow Clinical Research Facility, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Pioglitazone hydrochloride
Drug: Sitagliptin phosphate
Drug: Matching placebo to sitagliptin
Drug: Matching placebo to pioglitazone
Drug: Metformin

First Posted Date: 2008-07-25

Last Posted Date: 2017-05-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1615

Registration Number: NCT00722371

Metformin in Children With Motor Deficit

Not Applicable

Completed

Conditions: Spina Bifida
Neuromuscular Diseases

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2008-07-22

Last Posted Date: 2024-06-17

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 42

Registration Number: NCT00720161

Locations: 🇧🇪
UZLeuven, Leuven, Brabant, Belgium

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Basal Insulin
Drug: Metformin
Device: Pen auto-injector

First Posted Date: 2008-07-15

Last Posted Date: 2016-11-28

Lead Sponsor: Sanofi

Target Recruit Count: 496

Registration Number: NCT00715624

Locations: 🇬🇧
Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)

Phase 3

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Behavioral: Lifestyle Modification
Drug: placebo
Drug: Oral Contraceptive Pills (Yasmin)
Drug: Metformin

First Posted Date: 2008-07-14

Last Posted Date: 2015-05-15

Lead Sponsor: University of Rochester

Target Recruit Count: 43

Registration Number: NCT00714233

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Sulfonylurea
Drug: Metformin

First Posted Date: 2008-07-14

Last Posted Date: 2016-12-14

Lead Sponsor: Sanofi

Target Recruit Count: 859

Registration Number: NCT00713830

Locations: 🇹🇷
Sanofi-Aventis Administrative Office, Istanbul, Turkey

GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Metformin

First Posted Date: 2008-07-10

Last Posted Date: 2016-12-15

Lead Sponsor: Sanofi

Target Recruit Count: 680

Registration Number: NCT00712673

Locations: 🇦🇺
sanofi-aventis Australia & New Zealand administrative office, Macquarie Park, Australia
🇻🇪
Sanofi-Aventis Administrative Office, Caracas, Venezuela