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
-

Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-11-06
Last Posted Date
2020-12-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
914
Registration Number
NCT00396357
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

🇩🇪

Novartis Investigative Site, Multiple Locations, Germany

An Open-label Trial of Metformin for Weight Control of Pediatric Patients on Antipsychotic Medications.

First Posted Date
2006-10-23
Last Posted Date
2010-03-25
Lead Sponsor
Cambridge Health Alliance
Target Recruit Count
11
Registration Number
NCT00391261
Locations
🇺🇸

Cambridge Health Alliance, Medford, Massachusetts, United States

Effect of Metformin on Lactate Metabolism

Phase 1
Completed
Conditions
First Posted Date
2006-10-19
Last Posted Date
2008-10-07
Lead Sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Target Recruit Count
20
Registration Number
NCT00390273
Locations
🇫🇷

Centre Hospitalier Universitaire de Grenoble, Grenoble cedex 9, France

Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

First Posted Date
2006-09-28
Last Posted Date
2020-12-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1179
Registration Number
NCT00382096
Locations
🇺🇸

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

First Posted Date
2006-09-22
Last Posted Date
2017-03-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
4447
Registration Number
NCT00379769
Locations
🇬🇧

GSK Investigational Site, Worle, Weston-Super-Mare, United Kingdom

Metabolic Effects of Treatment in Patients With Recently Diagnosed Type 2 Diabetes

First Posted Date
2006-09-07
Last Posted Date
2012-11-02
Lead Sponsor
Aristotle University Of Thessaloniki
Target Recruit Count
100
Registration Number
NCT00373178
Locations
🇬🇷

AHEPA University Hospital of Thessaloniki, Thessaloniki, Greece

🇬🇷

Aristotle University of Thessaloniki, Thessaloniki, Greece

Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance

First Posted Date
2006-08-31
Last Posted Date
2006-11-14
Lead Sponsor
University of Turin, Italy
Target Recruit Count
200
Registration Number
NCT00370617
Locations
🇮🇹

Division of Gastroenterology, University of Torino, Ospedale San Giovanni Battista, Torino, Italy

Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

Phase 4
Completed
Conditions
First Posted Date
2006-08-22
Last Posted Date
2010-07-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
84
Registration Number
NCT00367055

The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes

First Posted Date
2006-08-21
Last Posted Date
2010-11-25
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
500
Registration Number
NCT00366301
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO

First Posted Date
2006-08-10
Last Posted Date
2010-04-16
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
482
Registration Number
NCT00362323
Locations
🇨🇿

C LF23-0121 06 01 Site107, Brno, Czech Republic

🇨🇿

C LF23-0121 06 01 Site108, Holesov, Czech Republic

🇨🇿

C LF23-0121 06 01 Site106, Olomouc, Czech Republic

and more 67 locations
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