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

Polycystic Ovary Syndrome Genetics and Treatment Response

Not Applicable

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin ER
Drug: Metformin

First Posted Date: 2011-07-08

Last Posted Date: 2018-08-16

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 200

Registration Number: NCT01389778

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin glycinate
Drug: Metformin hydrochloride

First Posted Date: 2011-07-01

Last Posted Date: 2018-01-30

Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Target Recruit Count: 203

Registration Number: NCT01386671

Locations: 🇲🇽
Unidad Antidiabética Integral, Mexico City, AA, Mexico
🇲🇽
Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social, Mexico City, Distrito Federal, Mexico
🇲🇽
Instituto de terapéutica experimental y clínica (INTEC), Guadalajara, Jalisco, Mexico

and more 1 locations

A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Canagliflozin 100mg
Drug: Placebo
Drug: Canagliflozin 300mg
Drug: Metformin
Drug: Sulphonylurea

First Posted Date: 2011-06-27

Last Posted Date: 2014-05-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 678

Registration Number: NCT01381900

A Study to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Type 2 Diabetes Mellitus Patients

Phase 3

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Metformin
Drug: CJ-30001/CJ-30002

First Posted Date: 2011-06-10

Last Posted Date: 2013-02-15

Lead Sponsor: HK inno.N Corporation

Target Recruit Count: 187

Registration Number: NCT01370707

Locations: 🇰🇷
Pusan National University Hospital, Pusan, Korea, Republic of
🇰🇷
National Health Insurance Coporation Ilsan Hospital, Ilsan, Korea, Republic of
🇰🇷
Kyungpook University Hospital, Daegu, Korea, Republic of

and more 18 locations

Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: BI 10773
Drug: Placebo (low dose)
Drug: Metformin
Drug: Placebo (high dose)

First Posted Date: 2011-06-07

Last Posted Date: 2014-06-17

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1162

Registration Number: NCT01368081

Locations: 🇯🇵
1245.52.033 Boehringer Ingelheim Investigational Site, Isehara, Kanagawa, Japan
🇯🇵
1245.52.052 Boehringer Ingelheim Investigational Site, Kitakyushu, Fukuoka, Japan
🇯🇵
1245.52.073 Boehringer Ingelheim Investigational Site, Chiyoda-ku, Tokyo, Japan

and more 84 locations

Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome

Phase 4

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin

First Posted Date: 2011-06-06

Last Posted Date: 2011-06-06

Lead Sponsor: Biocinese

Target Recruit Count: 24

Registration Number: NCT01366391

Locations: 🇧🇷
Biocinese, Toledo, Parana, Brazil

Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg

Not Applicable

Conditions: Nutritional and Metabolic Diseases

Interventions: Drug: Metformin
Drug: Glifage

First Posted Date: 2011-06-06

Last Posted Date: 2011-06-06

Lead Sponsor: Biocinese

Target Recruit Count: 26

Registration Number: NCT01367054

Locations: 🇧🇷
Biocinese, Toledo, Pr, Brazil

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Saxagliptin
Drug: Saxagliptin/metformin fixed-dose combination (FDC)
Drug: Saxagliptin/Metformin FDC
Drug: Metformin extended-release (XR)
Drug: Metformin

First Posted Date: 2011-06-03

Last Posted Date: 2015-05-08

Lead Sponsor: AstraZeneca

Target Recruit Count: 112

Registration Number: NCT01365091

Locations: 🇧🇷
Local Institution, Campinas, Sao Paulo, Brazil

An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Antihyperglycemic Medication
Drug: Metformin
Drug: Sulfonylurea
Drug: Sitagliptin

First Posted Date: 2011-05-20

Last Posted Date: 2017-06-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 3453

Registration Number: NCT01357135

Metformin in Women With Type 2 Diabetes in Pregnancy Trial

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo Comparator
Drug: Metformin

First Posted Date: 2011-05-13

Last Posted Date: 2020-03-03

Lead Sponsor: Mount Sinai Hospital, Canada

Target Recruit Count: 500

Registration Number: NCT01353391

Locations: 🇨🇦
The Centre for Mother, Infant, and Child Research, Sunnybrook Research Institute, Toronto, Ontario, Canada

Drug Development Updates

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