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 Metformin-FMD Trial

Phase 4

Completed

Conditions: Ischemia Reperfusion Injury
Endothelial Function

Interventions: Drug: Pretreatment with metformin in combination of infusion of caffeine.
Drug: No pretreatment with metformin in combination with infusion of caffeine
Drug: Metformin

First Posted Date: 2012-06-04

Last Posted Date: 2013-05-20

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 26

Registration Number: NCT01610401

Locations: 🇳🇱
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands

Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Liraglutide
Drug: Insulin Glargine
Drug: Metformin

First Posted Date: 2012-05-11

Last Posted Date: 2016-10-14

Lead Sponsor: Sanofi

Target Recruit Count: 142

Registration Number: NCT01596504

Locations: 🇩🇪
Investigational Site Number 276008, Berlin, Germany
🇩🇪
Investigational Site Number 276006, Berlin, Germany
🇩🇪
Investigational Site Number 276005, Mönchengladbach, Germany

and more 5 locations

Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin

First Posted Date: 2012-05-09

Last Posted Date: 2012-05-11

Lead Sponsor: Catholic University of the Sacred Heart

Target Recruit Count: 60

Registration Number: NCT01594697

Locations: 🇮🇹
Catholic University of Sacred Heart, Rome, Italy

Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: Pioglitazone

First Posted Date: 2012-05-08

Last Posted Date: 2012-05-09

Lead Sponsor: Tehran University of Medical Sciences

Target Recruit Count: 98

Registration Number: NCT01593371

Locations: 🇮🇷
Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Sitagliptin
Biological: Insulin
Drug: Metformin

First Posted Date: 2012-05-03

Last Posted Date: 2018-08-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 467

Registration Number: NCT01590797

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Sitagliptin
Drug: Gliclazide
Drug: Glimepiride
Drug: Metformin

First Posted Date: 2012-05-03

Last Posted Date: 2018-08-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 498

Registration Number: NCT01590771

Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Pioglitazone hydrochloride
Drug: Metformin hydrochloride

First Posted Date: 2012-05-02

Last Posted Date: 2014-02-28

Lead Sponsor: University of Dhaka

Target Recruit Count: 77

Registration Number: NCT01589445

Locations: 🇧🇩
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), Dhaka, Bangladesh

Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer

Phase 2

Completed

Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2012-05-01

Last Posted Date: 2018-09-10

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 208

Registration Number: NCT01589367

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome
Pregnancy

Interventions: Drug: placebo
Drug: Metformin

First Posted Date: 2012-04-30

Last Posted Date: 2019-02-26

Lead Sponsor: Norwegian University of Science and Technology

Target Recruit Count: 489

Registration Number: NCT01587378

Locations: 🇳🇴
Sykehuset Innlandet, Brumunddal, Norway
🇳🇴
Haukeland University Hospital, Bergen, Norway
🇳🇴
Nordlandssykehuset HF, Bodø, Norway

and more 10 locations

Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

Phase 3

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Yasmin;
Drug: Metformin plus Yasmin
Drug: Metformin

First Posted Date: 2012-04-20

Last Posted Date: 2012-04-20

Lead Sponsor: Catholic University of the Sacred Heart

Target Recruit Count: 99

Registration Number: NCT01581814

Locations: 🇮🇹
Policlinico A. Gemelli, Rome, Italy

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy