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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
-

Treatment Insulin Resistence in HCV G-1 Patient

Phase 4
Completed
Conditions
Chronic Hepatitis C
Interventions
Other: Placebo of metformine
Drug: Metformine
First Posted Date
2007-10-19
Last Posted Date
2007-10-19
Lead Sponsor
Valme University Hospital
Target Recruit Count
126
Registration Number
NCT00546442
Locations
🇪🇸

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

🇪🇸

Hospital de Leon, Leon, Spain

🇪🇸

Hospital del Mar, Barcelona, Spain

and more 16 locations

Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients

Phase 2
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2007-10-16
Last Posted Date
2008-05-22
Lead Sponsor
Air Force Military Medical University, China
Target Recruit Count
240
Registration Number
NCT00544518
Locations
🇨🇳

XiJing hospital of Fourth Military Medical University, Xi'an, Shanxi, China

Physical Inactivity and Insulin Resistance in Skeletal Muscle.

Not Applicable
Withdrawn
Conditions
Metabolic Syndrome X
Insulin Resistance
Hypertension
Hypercholesterolemia
Obesity
Interventions
Behavioral: Exercise
Drug: Metformin
First Posted Date
2007-09-27
Last Posted Date
2021-05-04
Lead Sponsor
University of Kansas Medical Center
Registration Number
NCT00536211
Locations
🇺🇸

Harry S. Truman Memorial Veterans' Hospital, Columbia, Missouri, United States

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2007-09-12
Last Posted Date
2015-10-20
Lead Sponsor
AstraZeneca
Target Recruit Count
915
Registration Number
NCT00528879
Locations
🇺🇸

Clinical Research Advantage / Desert Clinical Res, Llc, Tempe, Arizona, United States

🇺🇸

Raikhel, Marina, Torrance, California, United States

🇺🇸

Office Of Dr. Gray, Spokane, Washington, United States

and more 26 locations

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2007-09-12
Last Posted Date
2015-10-20
Lead Sponsor
AstraZeneca
Target Recruit Count
1067
Registration Number
NCT00528372
Locations
🇺🇸

Banksville Medical, Pc, Pittsburgh, Pennsylvania, United States

🇺🇸

Ritchken & First M.D.'S, San Diego, California, United States

🇺🇸

Village Family Practice, Houston, Texas, United States

and more 36 locations

A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: GSK189075
Drug: Metformin
Drug: Placebo
First Posted Date
2007-08-22
Last Posted Date
2017-09-06
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
50
Registration Number
NCT00519480
Locations
🇩🇪

GSK Investigational Site, Berlin, Germany

Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

Phase 4
Completed
Conditions
Type 2 Diabetes
Coronary Artery Disease
Interventions
First Posted Date
2007-08-08
Last Posted Date
2011-04-26
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Target Recruit Count
304
Registration Number
NCT00513630
Locations
🇨🇳

Shanghai Jiao Tong University School of Medicine, Shanghai, China

Metformin Administration in Infertile Anovulatory PCOS Patients

Phase 4
Withdrawn
Conditions
Polycystic Ovary Syndrome
Interventions
First Posted Date
2007-07-16
Last Posted Date
2013-04-09
Lead Sponsor
University Magna Graecia
Registration Number
NCT00501787
Locations
🇮🇹

Pugliese Hospital, Catanzaro, Catanzaro, CZ, Italy

Metformin in Infertile PCOS Patients

Phase 4
Conditions
Polycystic Ovary Syndrome
Interventions
First Posted Date
2007-07-16
Last Posted Date
2015-12-03
Lead Sponsor
University Magna Graecia
Target Recruit Count
20
Registration Number
NCT00501904
Locations
🇮🇹

Pugliese Hospital, Catanzaro, Catanzaro, CZ, Italy, Italy

Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2007-06-26
Last Posted Date
2016-03-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
187
Registration Number
NCT00491725
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