MedPath

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 and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2011-10-26
Last Posted Date
2015-01-21
Lead Sponsor
Sanofi
Target Recruit Count
538
Registration Number
NCT01459809
Locations
🇹🇷

Investigational Site Number 792-002, Kutahya, Turkey

🇦🇪

Investigational Site Number 784-001, Dubai, United Arab Emirates

🇪🇬

Investigational Site Number 81802, Cairo, Egypt

and more 52 locations

Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

Phase 2
Completed
Conditions
Barrett Esophagus
Esophageal Cancer
Interventions
First Posted Date
2011-10-06
Last Posted Date
2014-07-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
93
Registration Number
NCT01447927
Locations
🇵🇷

University of Puerto Rico, San Juan, Puerto Rico

🇺🇸

Hines Veterans Administration Hospital, Hines, Illinois, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

and more 4 locations

Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy

Phase 1
Completed
Conditions
Cancer
Interventions
First Posted Date
2011-09-29
Last Posted Date
2017-05-09
Lead Sponsor
Tufts Medical Center
Target Recruit Count
105
Registration Number
NCT01442870
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers

Phase 1
Terminated
Conditions
Colon Cancer
Interventions
First Posted Date
2011-09-26
Last Posted Date
2015-03-26
Lead Sponsor
Tufts Medical Center
Target Recruit Count
9
Registration Number
NCT01440127
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial

Phase 4
Completed
Conditions
Cardiovascular Disease
Ischemic Heart Disease
Interventions
Drug: Metformin
Drug: Placebo
First Posted Date
2011-09-22
Last Posted Date
2014-07-29
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
100
Registration Number
NCT01438723
Locations
🇳🇱

RUNMC, Nijmegen, Gelderland, Netherlands

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2011-09-22
Last Posted Date
2014-11-25
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
689
Registration Number
NCT01438814
Locations
🇧🇪

1218.60.32001 Boehringer Ingelheim Investigational Site, Genk, Belgium

🇧🇪

1218.60.32005 Boehringer Ingelheim Investigational Site, Ham, Belgium

🇧🇪

1218.60.32004 Boehringer Ingelheim Investigational Site, Natoye, Belgium

and more 87 locations

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

Phase 2
Completed
Conditions
Stage IIB Prostate Cancer
Stage I Prostate Cancer
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IIA Prostate Cancer
Interventions
Other: placebo
Drug: metformin hydrochloride
Other: laboratory biomarker analysis
First Posted Date
2011-09-14
Last Posted Date
2018-01-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT01433913
Locations
🇺🇸

Arizona Cancer Center - Tucson, Tucson, Arizona, United States

🇺🇸

University of Arizona Health Sciences Center, Tucson, Arizona, United States

🇺🇸

University of Southern California/Norris Cancer Center, Los Angeles, California, United States

Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

Phase 1
Active, not recruiting
Conditions
Glioblastoma
Gliosarcoma
Supratentorial Glioblastoma
Interventions
First Posted Date
2011-09-08
Last Posted Date
2024-07-29
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
144
Registration Number
NCT01430351
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Endothelial Disfunction Treatment With Glimepiride/Metformin Combination (Glimetal) in Type 2 Diabetes Patients

Phase 4
Completed
Conditions
Endothelial Dysfunction
Diabetes Mellitus
Interventions
Drug: Glimepiride/metformin
Drug: Metformin
First Posted Date
2011-09-07
Last Posted Date
2011-09-07
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Target Recruit Count
16
Registration Number
NCT01429818
Locations
🇲🇽

Unidad PET Ciclotrón. Facultad de Medicina. Universidad Nacional Autónoma de México, Mexico city, Distrito Federal, Mexico

Effect of Metformin on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome
Hyperandrogenism
Interventions
First Posted Date
2011-09-01
Last Posted Date
2021-01-08
Lead Sponsor
University of Virginia
Target Recruit Count
25
Registration Number
NCT01427595
Locations
🇺🇸

Center for Research in Reproduction, University of Virginia, Charlottesville, Virginia, United States

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