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

The RCT of Acupuncture on PCOS Combined With IR

Phase 3

Completed

Conditions: Polycystic Ovary Syndrome
Insulin Resistance

Interventions: Other: true acupuncture
Other: sham acupuncture
Drug: Placebo metformin
Drug: metformin

First Posted Date: 2015-07-08

Last Posted Date: 2022-03-21

Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Target Recruit Count: 342

Registration Number: NCT02491333

Locations: 🇨🇳
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

A Study of Liposomal Doxorubicin + Docetaxel + Trastuzumab + Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer

Phase 2

Completed

Conditions: HER-2 Positive Breast Cancer

Interventions: Drug: Liposomal doxorubicin
Drug: Docetaxel
Drug: Trastuzumab
Drug: Metformin

First Posted Date: 2015-07-02

Last Posted Date: 2020-04-21

Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Target Recruit Count: 49

Registration Number: NCT02488564

Locations: 🇮🇹
Oncologia Medica AUSL Imola, Imola, Italy
🇮🇹
U.O Oncologia AUSLdella Romagna, Rimini, RN, Italy
🇮🇹
Day Hospital Oncologico, Ospedale Guastalla, Guastalla, Italy

and more 6 locations

DiaFrail: A Short Duration Study in Older People ( DIAFRAIL Study)

Phase 3

Withdrawn

Conditions: Diabetes Mellitus

Interventions: Drug: Glimepiride
Drug: Metformin

First Posted Date: 2015-06-29

Last Posted Date: 2017-07-28

Lead Sponsor: Diabetes Frail Ltd

Registration Number: NCT02484209

Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome

Phase 4

Completed

Conditions: PCOS
Obesity

Interventions: Drug: Glucophage tablets and Victoza
Drug: Metformin

First Posted Date: 2015-06-26

Last Posted Date: 2015-06-26

Lead Sponsor: University Medical Centre Ljubljana

Target Recruit Count: 40

Registration Number: NCT02483299

Locations: 🇸🇮
University Medical Center Ljubljana, Ljubljana, Slovenia

Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

Phase 3

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: PEX168(100µg)
Drug: PEX168(200µg)
Drug: Metformin

First Posted Date: 2015-06-23

Last Posted Date: 2017-01-24

Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Target Recruit Count: 587

Registration Number: NCT02477969

Locations: 🇨🇳
Shanghai sixth People's Hospital, Shanghai, Shanghai, China

Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer

Phase 2

Terminated

Conditions: Adenocarcinoma
Carcinoma
Rectal Neoplasms

Interventions: Drug: Capecitabine
Drug: Metformin
Radiation: Radiotherapy
Drug: Placebo

First Posted Date: 2015-06-16

Last Posted Date: 2017-11-28

Lead Sponsor: University of Campinas, Brazil

Target Recruit Count: 3

Registration Number: NCT02473094

Locations: 🇧🇷
Clinical Oncology Department - General Hospital - State University of Campinas (UNICAMP), Campinas, São Paulo, Brazil

Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer
Breast Tumors

Interventions: Drug: Doxorubicin
Drug: Metformin

First Posted Date: 2015-06-15

Last Posted Date: 2019-10-16

Lead Sponsor: Avera McKennan Hospital & University Health Center

Target Recruit Count: 30

Registration Number: NCT02472353

Locations: 🇺🇸
Avera Cancer Institute, Sioux Falls, South Dakota, United States

Metformin Experience on Minimal Hepatic Encephalopathy

Phase 4

Conditions: Hepatic Encephalopathy
Liver Cirrhosis

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2015-06-12

Last Posted Date: 2015-06-12

Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Target Recruit Count: 30

Registration Number: NCT02470546

Locations: 🇪🇸
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI), Sevilla, Spain

Three New Ideas to Protect Special Forces From the Stress of High Altitude

Phase 4

Completed

Conditions: Mountain Sickness

Interventions: Dietary Supplement: Quercetin
Drug: Nifedipine extended release
Drug: Placebo
Drug: Metformin
Drug: Nitrite
Drug: Methazolamide

First Posted Date: 2015-06-04

Last Posted Date: 2021-03-30

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 148

Registration Number: NCT02463357

Locations: 🇺🇸
Alma College, Alma, Michigan, United States

Metformin and Congenital Nephrogenic Diabetes Insipidus

Phase 1

Terminated

Conditions: Diabetes Insipidus

Interventions: Drug: Metformin

First Posted Date: 2015-06-02

Last Posted Date: 2018-07-17

Lead Sponsor: Emory University

Target Recruit Count: 2

Registration Number: NCT02460354

Locations: 🇺🇸
Childen's Healthcare of Atlanta, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI), Atlanta, Georgia, United States

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