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

Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Phase 4

Completed

Conditions: Patients With Glucocorticoid Treatment

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2010-08-24

Last Posted Date: 2016-04-28

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 29

Registration Number: NCT01187849

Locations: 🇨🇭
University Hospital Basel, Basel, Basel-Stadt, Switzerland

Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: insulin glargine
Other: Standard glycemic care
Drug: metformin
Drug: acarbose
Behavioral: lifestyle therapy

First Posted Date: 2010-08-13

Last Posted Date: 2020-05-21

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 83

Registration Number: NCT01181674

Locations: 🇨🇦
McMaster University Medical Centre, Diabetes Care and Research Program, Hamilton, Ontario, Canada

Metformin for Weight Loss in Schizophrenia

Not Applicable

Terminated

Conditions: Schizophrenia
Obesity

Interventions: Drug: Metformin

First Posted Date: 2010-08-09

Last Posted Date: 2017-09-01

Lead Sponsor: Nathan Kline Institute for Psychiatric Research

Target Recruit Count: 12

Registration Number: NCT01177709

Locations: 🇺🇸
Manhatan Psychiatric Center, New York, New York, United States

Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Liraglutide
Device: Pen auto-injector
Device: Pre-filled pen injector
Drug: Metformin

First Posted Date: 2010-08-04

Last Posted Date: 2016-11-28

Lead Sponsor: Sanofi

Target Recruit Count: 148

Registration Number: NCT01175473

Locations: 🇩🇪
Sanofi-Aventis Investigational Site Number 276004, Kiel, Germany
🇩🇪
Sanofi-Aventis Investigational Site Number 276002, Mainz, Germany
🇩🇪
Sanofi-Aventis Investigational Site Number 276006, Berlin, Germany

and more 4 locations

Early Intervention for Gestational Diabetes

Not Applicable

Withdrawn

Conditions: Gestational Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2010-07-28

Last Posted Date: 2013-01-16

Lead Sponsor: Intermountain Health Care, Inc.

Registration Number: NCT01171456

Locations: 🇺🇸
Intermountain Medical Center, Murray, Utah, United States

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Metformin
Drug: Sulfonylurea

First Posted Date: 2010-07-26

Last Posted Date: 2016-10-13

Lead Sponsor: Sanofi

Target Recruit Count: 391

Registration Number: NCT01169779

Locations: 🇨🇳
Investigational Site Number 156009, Beijing, China
🇨🇳
Investigational Site Number 156016, Changsha, China
🇨🇳
Investigational Site Number 156015, Changsha, China

and more 32 locations