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

Improving the Treatment for Women With Early Stage Cancer of the Uterus

Phase 2

Active, not recruiting

Conditions: Complex Endometrial Hyperplasia With Atypia
Grade 1 Endometrial Endometrioid Adenocarcinoma

Interventions: Drug: Levonorgestrel
Drug: Metformin

First Posted Date: 2012-09-17

Last Posted Date: 2024-08-28

Lead Sponsor: Queensland Centre for Gynaecological Cancer

Target Recruit Count: 165

Registration Number: NCT01686126

Locations: 🇦🇺
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
🇦🇺
King Edward Memorial Hospital for Women, Perth, Western Australia, Australia
🇦🇺
Royal Women's Hospital, Carlton, Victoria, Australia

and more 14 locations

Metformin for the Treatment of Endometrial Hyperplasia

Early Phase 1

Completed

Conditions: Endometrial Hyperplasia Without Atypia
Endometrial Hyperplasia

Interventions: Drug: Metformin

First Posted Date: 2012-09-14

Last Posted Date: 2019-01-18

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 18

Registration Number: NCT01685762

Locations: 🇺🇸
Southern Pines Women's Health Center, Southern Pines, North Carolina, United States
🇺🇸
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo to Omarigliptin
Drug: Omarigliptin
Drug: Glimepiride
Drug: Glimepiride Placebo
Drug: Metformin
Drug: Insulin Glargine

First Posted Date: 2012-09-11

Last Posted Date: 2018-09-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 751

Registration Number: NCT01682759

Effect of Genetic Variation in the Transporter OCT2, MATE1 and MATE2-K on the PKPD of Metformin

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Metformin

First Posted Date: 2012-09-10

Last Posted Date: 2014-07-02

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 41

Registration Number: NCT01681680

Effect of Genetic Variants in MATE1 and OCT3 on the Pharmacodynamics of Metformin in African Americans

Phase 1

Completed

Conditions: Healthy
Type 2 Diabetes Mellitus

Interventions: Drug: Metformin

First Posted Date: 2012-09-10

Last Posted Date: 2014-10-23

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 33

Registration Number: NCT01681693

Locations: 🇺🇸
San Francisco General Hospital, San Francisco, California, United States

Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Clomiphene
Drug: Letrozole
Drug: Metformin

First Posted Date: 2012-09-06

Last Posted Date: 2012-09-07

Lead Sponsor: Assiut University

Target Recruit Count: 200

Registration Number: NCT01679574

Locations: 🇪🇬
Assiut University, Assiut, Egypt

A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)

Phase 3

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin/Simvastatin FDC
Drug: Sitagliptin
Drug: Simvastatin
Drug: Placebo to sitagliptin
Drug: Placebo to Sitagliptin/Simvastatin FDC
Drug: Placebo to simvastatin
Drug: Metformin
Drug: Glimepiride

First Posted Date: 2012-09-05

Last Posted Date: 2018-08-24

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 299

Registration Number: NCT01678820

Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients

Phase 2

Completed

Conditions: Metastatic Prostate Cancer

Interventions: Drug: Metformin

First Posted Date: 2012-09-03

Last Posted Date: 2019-03-05

Lead Sponsor: Kantonsspital Graubünden

Target Recruit Count: 25

Registration Number: NCT01677897

Locations: 🇨🇭
Kantonsspital Graubünden, Chur, Graubünden, Switzerland

Obesity in Children and Adolescents: Associated Risks and Early Intervention

Phase 3

Completed

Conditions: Obesity

Interventions: Drug: Metformin

First Posted Date: 2012-09-03

Last Posted Date: 2016-03-04

Lead Sponsor: Lithuanian University of Health Sciences

Target Recruit Count: 182

Registration Number: NCT01677923

Locations: 🇱🇹
Rasa Verkauskiene, Kaunas, Eiveniu str. 2, Lithuania

Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Empagliflozin + Metformin
Drug: Empagliflozin
Drug: Metformin

First Posted Date: 2012-08-27

Last Posted Date: 2015-08-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 36

Registration Number: NCT01672788

Locations: 🇩🇪
1276.7.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

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