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

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Phase 2

Terminated

Conditions: Metabolic Syndrome X
Obesity

Interventions: Drug: Metformin
Drug: Placebo
Drug: Orlistat
Drug: Topiramate

First Posted Date: 2011-05-11

Last Posted Date: 2021-06-09

Lead Sponsor: University of Iowa

Target Recruit Count: 136

Registration Number: NCT01351753

Locations: 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin

First Posted Date: 2011-05-06

Last Posted Date: 2012-02-09

Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Target Recruit Count: 25

Registration Number: NCT01349387

Locations: 🇫🇷
Centre Hospitalier Sud Francilien, Corbeil Essonnes, France

Metformin in Postmenopausal Women With Metabolic Syndrome

Phase 4

Conditions: Metabolic Syndrome

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2011-04-27

Last Posted Date: 2011-05-17

Lead Sponsor: Mahidol University

Target Recruit Count: 40

Registration Number: NCT01342744

Locations: 🇹🇭
Siriraj Hospital, Bangkoknoi, Bangkok, Thailand

The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension

Not Applicable

Completed

Conditions: Diabetes Mellitus
Essential Hypertension

Interventions: Drug: Fosinopril
Drug: Metformin

First Posted Date: 2011-04-27

Last Posted Date: 2011-05-13

Lead Sponsor: China-Japan Friendship Hospital

Target Recruit Count: 140

Registration Number: NCT01342614

Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Sitagliptin
Drug: Glimepiride
Drug: Metformin
Drug: Insulin

First Posted Date: 2011-04-26

Last Posted Date: 2014-05-30

Lead Sponsor: Jothydev's Diabetes and Research Centre

Target Recruit Count: 440

Registration Number: NCT01341717

Locations: 🇮🇳
Jothydev's Diabetes and Research Center, Thiruvananthapuram, Kerala, India

Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer

Not Applicable

Completed

Conditions: Malignant Neoplasm of Thyroid Stage I
Malignant Neoplasm of Thyroid Stage II

Interventions: Drug: Metformin

First Posted Date: 2011-04-26

Last Posted Date: 2011-04-26

Lead Sponsor: Mashhad University of Medical Sciences

Target Recruit Count: 51

Registration Number: NCT01341886

Locations: 🇮🇷
Mashad University of Medical Sciences, Mashad, Khorasan Razavi, Iran, Islamic Republic of

Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin
Drug: Sulfonylurea
Drug: Metformin

First Posted Date: 2011-04-25

Last Posted Date: 2017-06-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 870

Registration Number: NCT01340768

Exercise and Metformin in Colorectal and Breast Cancer Survivors

Phase 2

Completed

Conditions: Breast Cancer
Colorectal Cancer

Interventions: Other: Educational information
Behavioral: Exercise training
Drug: Metformin

First Posted Date: 2011-04-22

Last Posted Date: 2018-06-06

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 139

Registration Number: NCT01340300

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Yale School of Medicine, New Haven, Connecticut, United States