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

Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

Not Applicable

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin

First Posted Date: 2011-04-13

Last Posted Date: 2011-04-13

Lead Sponsor: Casa Sollievo della Sofferenza IRCCS

Target Recruit Count: 100

Registration Number: NCT01334684

Locations: 🇮🇹
Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, Italy

Adjunctive Metformin Therapy in Double Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2011-04-12

Last Posted Date: 2016-03-04

Lead Sponsor: University of Massachusetts, Worcester

Target Recruit Count: 28

Registration Number: NCT01334125

Locations: 🇺🇸
UmassMemorial Medical Center, Worcester, Massachusetts, United States

Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

Phase 1

Conditions: Gestational Diabetes Mellitus

Interventions: Drug: Glyburide
Drug: Metformin
Drug: Glyburide-Metformin combination

First Posted Date: 2011-04-05

Last Posted Date: 2015-02-10

Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Target Recruit Count: 360

Registration Number: NCT01329016

Locations: 🇺🇸
University of Washington, Seattle, Washington, United States
🇺🇸
University of Texas Medical Branch, Galveston, Texas, United States
🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 1 locations

Vincristine, Dexamethasone, Doxorubicin, and PEG-asparaginase (VPLD) and Metformin for Relapsed Childhood Acute Lymphoblastic Leukemia (ALL)

Phase 1

Completed

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Metformin
Drug: Vincristine
Drug: Dexamethasone
Drug: PEG-asparaginase
Drug: Doxorubicin
Drug: Intrathecal chemotherapy

First Posted Date: 2011-03-28

Last Posted Date: 2017-08-07

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 14

Registration Number: NCT01324180

Locations: 🇺🇸
Holtz Children's Hospital University of Miami Miller School of Medicine, Miami, Florida, United States
🇺🇸
Arnold Palmer Hospital for Children, Orlando, Florida, United States
🇺🇸
All Children's Hospital, Saint Petersburg, Florida, United States

and more 2 locations

Prevention of Metabolic Complications of Glucocorticoid Excess

Phase 2

Completed

Conditions: Iatrogenic Cushing Disease

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2011-03-22

Last Posted Date: 2019-04-12

Lead Sponsor: Barts & The London NHS Trust

Target Recruit Count: 57

Registration Number: NCT01319994

Locations: 🇬🇧
Barts and the London, London, United Kingdom

Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Alogliptin and metformin
Drug: Metformin

First Posted Date: 2011-03-18

Last Posted Date: 2012-02-03

Lead Sponsor: Takeda

Target Recruit Count: 288

Registration Number: NCT01318109

Diabetic Treatment Adherence

Completed

Conditions: Endocrine System Diseases

Interventions: Drug: Metformin
Behavioral: Questionnaires

First Posted Date: 2011-03-18

Last Posted Date: 2016-09-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 28

Registration Number: NCT01318564

Locations: 🇺🇸
Kelsey Seybold Clinics, Houston, Texas, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMI

Phase 2

Completed

Conditions: Adenomatous Polyp
Colorectal Cancer
Obesity

Interventions: Drug: metformin hydrochloride

First Posted Date: 2011-03-10

Last Posted Date: 2019-03-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT01312467

Locations: 🇺🇸
University of California Medical Center At Irvine-Orange Campus, Orange, California, United States
🇺🇸
Kaiser Permanente - Sacramento, Sacramento, California, United States
🇺🇸
Veterans Administration Long Beach Medical Center, Long Beach, California, United States

and more 1 locations

A Trial of Standard Chemotherapy With Metformin (vs Placebo) in Women With Metastatic Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2011-03-08

Last Posted Date: 2021-04-14

Lead Sponsor: Ozmosis Research Inc.

Target Recruit Count: 40

Registration Number: NCT01310231

Locations: 🇨🇦
London Regional Cancer Program, London, Ontario, Canada
🇨🇦
St. Michael's Hospital, Toronto, Ontario, Canada
🇨🇦
Mount Sinai Hospital, Toronto, Ontario, Canada

and more 2 locations

Glucose Control in Severely Burned Patients

Not Applicable

Completed

Conditions: Burns

Interventions: Drug: Metformin
Drug: Humulin R

First Posted Date: 2011-03-02

Last Posted Date: 2022-03-28

Lead Sponsor: Sunnybrook Health Sciences Centre

Target Recruit Count: 45

Registration Number: NCT01307306

Locations: 🇨🇦
Ross Tilley Burn Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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