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
-

Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus

First Posted Date
2009-07-17
Last Posted Date
2010-05-18
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Target Recruit Count
28
Registration Number
NCT00941161
Locations
🇲🇽

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, Mexico

Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-07-16
Last Posted Date
2010-05-18
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Target Recruit Count
20
Registration Number
NCT00940472
Locations
🇲🇽

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jal, Mexico

Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

First Posted Date
2009-07-09
Last Posted Date
2011-10-26
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
124
Registration Number
NCT00935805
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-30
Last Posted Date
2022-10-20
Lead Sponsor
Columbia University
Target Recruit Count
35
Registration Number
NCT00930579
Locations
🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

First Posted Date
2009-06-26
Last Posted Date
2015-08-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
61
Registration Number
NCT00929201

Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

First Posted Date
2009-06-19
Last Posted Date
2011-08-31
Lead Sponsor
Sanofi
Target Recruit Count
189
Registration Number
NCT00924573
Locations
🇯🇵

Sanofi-Aventis Administrative Office, Tokyo, Japan

Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

First Posted Date
2009-06-08
Last Posted Date
2014-05-14
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
567
Registration Number
NCT00915772
Locations
🇨🇦

1218.52.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

🇨🇦

1218.52.11002 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada

🇭🇷

1218.52.38502 Boehringer Ingelheim Investigational Site, Karlovac, Croatia

and more 109 locations

Efficacy and Safety of Adjuvant Metformin for Operable Breast Cancer Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-05-28
Last Posted Date
2015-07-29
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
105
Registration Number
NCT00909506
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)

First Posted Date
2009-05-14
Last Posted Date
2013-01-09
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
693
Registration Number
NCT00901979
Locations
🇺🇸

Metabolic Research Institute, Inc., West Palm Beach, Florida, United States

🇺🇸

John Muir Clinical Research, Concord, California, United States

🇺🇸

Dallas Diabetic and Endocrinology Research Center, Dallas, Texas, United States

and more 64 locations

Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients

First Posted Date
2009-05-12
Last Posted Date
2012-02-20
Lead Sponsor
Novartis
Target Recruit Count
556
Registration Number
NCT00900146
Locations
🇦🇷

Centro de Investigaciones Clinicas del Litoral, Santa Fe, Argentina

🇵🇪

Clinica Chiclayo, Chiclayo, Peru

🇮🇳

King George Hospital, Visakhapatnam, India

and more 85 locations
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