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

Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: sitagliptin
Drug: liraglutide
Drug: glimepiride
Drug: metformin

First Posted Date: 2011-02-15

Last Posted Date: 2017-06-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 653

Registration Number: NCT01296412

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo to alogliptin
Drug: Alogliptin
Drug: Metformin
Drug: Pioglitazone

First Posted Date: 2011-02-03

Last Posted Date: 2013-03-22

Lead Sponsor: Takeda

Target Recruit Count: 506

Registration Number: NCT01289119

Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

Conditions: Fatigue
Breast Cancer
Depression
Sleep Disorders

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2011-01-31

Last Posted Date: 2015-09-09

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 394

Registration Number: NCT01286233

Locations: 🇺🇸
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
🇺🇸
Kaiser Foundation Hospital - West Los Angeles, Los Angeles, California, United States
🇺🇸
Kaiser Permanente Medical Center - Redwood City, Redwood City, California, United States

and more 251 locations

Metformin Postpartum for GDM RCT for Reduced Weight Retention

Phase 4

Completed

Conditions: Diabetes, Gestational

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2011-01-20

Last Posted Date: 2018-11-28

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 114

Registration Number: NCT01280409

Locations: 🇺🇸
Memorial Hermann Hospital, Texas Medical Center, Houston, Texas, United States
🇺🇸
University of Texas Health Science Center at Houston, Professional Building, Houston, Texas, United States

Metformin Versus Acarbose Treatment in Infertile Overweight Women With Polycystic Ovary Syndrome (PCOS)

Phase 4

Completed

Conditions: PCO

Interventions: Drug: Metformin
Drug: Acarbose

First Posted Date: 2011-01-19

Last Posted Date: 2012-01-06

Lead Sponsor: Royan Institute

Target Recruit Count: 50

Registration Number: NCT01279512

Locations: 🇮🇷
Royan Institute, Tehran, Iran, Islamic Republic of

Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

Phase 4

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: biphasic insulin aspart 30
Drug: metformin

First Posted Date: 2011-01-17

Last Posted Date: 2014-10-27

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 179

Registration Number: NCT01278160

Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers

Not Applicable

Completed

Conditions: Healthy Adult

Interventions: Drug: Metformin

First Posted Date: 2011-01-11

Last Posted Date: 2012-05-11

Lead Sponsor: Yonsei University

Target Recruit Count: 30

Registration Number: NCT01274130

Locations: 🇰🇷
Severance Hospital, Seoul, Korea, Republic of

Metformin in Obese Non-diabetic Pregnant Women

Phase 2

Completed

Conditions: Obesity
Pregnancy Complications

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2011-01-10

Last Posted Date: 2016-01-22

Lead Sponsor: Epsom and St Helier University Hospitals NHS Trust

Target Recruit Count: 450

Registration Number: NCT01273584

Locations: 🇬🇧
Epsom and St Helier University Hospitals NHS Trust, Carshalton, Surrey, United Kingdom
🇬🇧
Medway Hospital NHS Trust, Gillingham, Kent, United Kingdom
🇬🇧
Kings College, London, London, United Kingdom

Effect of Metformin on Breast Cancer Metabolism

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Metformin

First Posted Date: 2010-12-24

Last Posted Date: 2014-07-02

Lead Sponsor: Oxford University Hospitals NHS Trust

Target Recruit Count: 41

Registration Number: NCT01266486

Locations: 🇬🇧
Mount Vernon Centre for Cancer Treatment, Rickmansworth Road, Northwood, Middlesex, United Kingdom
🇬🇧
Dept Oncology, Churchill Hospital, Old Road, Headington, Oxford, Oxfordshire, United Kingdom
🇬🇧
Surgery and Molecular Oncology Ninewells Hospital, Dundee, Scotland, United Kingdom

Metformin in Chronic Obstructive Pulmonary Disease

Phase 4

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2010-11-24

Last Posted Date: 2015-05-07

Lead Sponsor: St George's, University of London

Target Recruit Count: 52

Registration Number: NCT01247870

Locations: 🇬🇧
North Tees and Hartlepool NHS Trust, Hartlepool, Cleveland, United Kingdom
🇬🇧
University Hospitals of Morecambe Bay NHS Trust, Lancaster, Cumbria, United Kingdom
🇬🇧
East Sussex Healthcare NHS Trust, Hastings, East Sussex, United Kingdom

and more 6 locations

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