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

REducing With MetfOrmin Vascular Adverse Lesions in Type 1 Diabetes (REMOVAL)

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2011-12-01

Last Posted Date: 2019-06-19

Lead Sponsor: University of Glasgow

Target Recruit Count: 493

Registration Number: NCT01483560

Locations: 🇨🇦
St Joseph's Health Care, London, Ontario, Canada
🇨🇦
Ottawa Hospital Riverside Campus, Ottawa, Canada
🇳🇱
Maastricht University Medical Centre, Maastricht, Netherlands

and more 21 locations

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

Phase 3

Terminated

Conditions: Polycystic Ovary Syndrome

Interventions: Behavioral: Dietary Restriction
Behavioral: Exercise Training
Drug: Metformin

First Posted Date: 2011-11-30

Last Posted Date: 2022-03-15

Lead Sponsor: Pennington Biomedical Research Center

Target Recruit Count: 32

Registration Number: NCT01482286

Locations: 🇺🇸
Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer

Phase 2

Withdrawn

Conditions: Prostate Cancer

First Posted Date: 2011-11-23

Last Posted Date: 2013-03-06

Lead Sponsor: New Mexico Cancer Care Alliance

Registration Number: NCT01478308

Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer

Phase 2

Terminated

Conditions: Metastatic Breast Cancer

Interventions: Drug: Metformin
Drug: Lapatinib

First Posted Date: 2011-11-22

Last Posted Date: 2014-02-20

Lead Sponsor: Fondazione Michelangelo

Target Recruit Count: 32

Registration Number: NCT01477060

Locations: 🇮🇹
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni, Bergamo, BG, Italy
🇮🇹
Fondazione Poliambulanza, Brescia, BS, Italy
🇮🇹
Azienda Ospedaliera San Gerardo, Monza, MB, Italy

and more 8 locations

Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin

First Posted Date: 2011-11-18

Last Posted Date: 2011-11-21

Lead Sponsor: Hormozgan University of Medical Sciences

Target Recruit Count: 50

Registration Number: NCT01474967

Locations: 🇮🇷
Hormozgan University of Medical Sciences (HUMS), Bandarabbas, Hormozgan, Iran, Islamic Republic of

Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

Not Applicable

Conditions: Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM

Interventions: Drug: Jiangtangtiaozhi decoction
Drug: Metformin

First Posted Date: 2011-11-15

Last Posted Date: 2011-12-06

Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Target Recruit Count: 450

Registration Number: NCT01471275

Locations: 🇨🇳
Qinghai Provence Hospital of TCM, Xining, Qinghai, China
🇨🇳
Guang'anmen Hospital of China Academy ofChinese Medical Sciences, Beijing, Beijing, China
🇨🇳
Baoding Hospital of TCM, Baoding, Hebei, China

and more 5 locations

Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus

Early Phase 1

Completed

Conditions: Short Segment Barrett's Esophagus
Long Segment Barrett's Esophagus

Interventions: Drug: Omeprazole
Drug: Vitamin D3
Procedure: upper endoscopy
Drug: Metformin

First Posted Date: 2011-11-04

Last Posted Date: 2016-03-10

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 26

Registration Number: NCT01465113

Locations: 🇺🇸
University Hospitals Ahuja Medical Center, Beachwood, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States