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 Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)

Phase 4

Completed

Conditions: Schizophrenia

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2009-01-05

Last Posted Date: 2013-03-27

Lead Sponsor: National Institute of Mental Health (NIMH)

Target Recruit Count: 146

Registration Number: NCT00816907

Locations: 🇺🇸
Baylor College of Medicine, Houston, Texas, United States
🇺🇸
Mental Health Advocates, Boca Raton, Florida, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States

and more 13 locations

Pioglitazone Versus Metformin in Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Pioglitazone
Drug: Metformin

First Posted Date: 2008-12-30

Last Posted Date: 2015-11-18

Lead Sponsor: University of Campania "Luigi Vanvitelli"

Target Recruit Count: 150

Registration Number: NCT00815399

Locations: 🇮🇹
Department of Geriatrics and Metabolic Diseases, Naples, Italy

Evaluate Safety and Effectiveness of MBX-102 in Type 2 Diabetes Patients With Poor Glycemic Control on Metformin

Phase 2

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: MBX-102
Drug: Actos
Drug: Metformin

First Posted Date: 2008-12-24

Last Posted Date: 2015-04-17

Lead Sponsor: CymaBay Therapeutics, Inc.

Target Recruit Count: 242

Registration Number: NCT00814372

Locations: 🇮🇳
Mediciti Hospital, Hyderabad, India
🇮🇳
Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Indore, India
🇮🇳
Fortis Hospital, Jaipur, India

and more 23 locations

Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

Phase 1

Terminated

Conditions: Generalized Anxiety Disorder

Interventions: Drug: PD 0332334
Drug: Metformin

First Posted Date: 2008-12-17

Last Posted Date: 2010-02-17

Lead Sponsor: Pfizer

Target Recruit Count: 24

Registration Number: NCT00809536

Locations: 🇸🇬
Pfizer Investigational Site, Singapore, Singapore

Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

Phase 4

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: biphasic insulin aspart 30
Drug: biphasic human insulin 30
Drug: metformin

First Posted Date: 2008-12-11

Last Posted Date: 2015-03-04

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 145

Registration Number: NCT00807092

Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics

Phase 4

Completed

Conditions: Psychotic Disorders

Interventions: Drug: Aripiprazole or Perphenazine
Drug: Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine
Drug: Metformin

First Posted Date: 2008-12-10

Last Posted Date: 2017-04-25

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 127

Registration Number: NCT00806234

Locations: 🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸
University of North Carolina, Division of Child and Adolescent Psychiatry, Chapel Hill, North Carolina, United States
🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

and more 1 locations

Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia

Interventions: Drug: Olanzapine
Drug: Perphenazine
Drug: Aripiprazole
Drug: Metformin
Drug: Simvastatin
Drug: Benztropine

First Posted Date: 2008-12-04

Last Posted Date: 2013-02-08

Lead Sponsor: National Institute of Mental Health (NIMH)

Target Recruit Count: 21

Registration Number: NCT00802100

Locations: 🇺🇸
Medical College of Georgia, Augusta, Georgia, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
SHANTI Clinical Trials, Colton, California, United States

and more 10 locations

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Bi 1356 + metformin
Drug: matching placebo
Drug: metformin
Drug: BI 1356

First Posted Date: 2008-11-25

Last Posted Date: 2014-01-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 857

Registration Number: NCT00798161

Locations: 🇨🇦
1218.46.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada
🇨🇦
1218.46.11002 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada
🇨🇦
1218.46.11006 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada

and more 135 locations