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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
C4H11N5
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
-

Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study

Phase 3
Terminated
Conditions
Diabetes Mellitus, Type 2
Heart Failure, Congestive
First Posted Date
2006-05-15
Last Posted Date
2008-05-14
Lead Sponsor
University of Alberta
Target Recruit Count
100
Registration Number
NCT00325910
Locations
🇨🇦

University of Alberta Hospital, Edmonton, Alberta, Canada

🇨🇦

Misericordia Hospital, Edmonton, Alberta, Canada

Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

Not Applicable
Conditions
Polycystic Ovary Syndrome
First Posted Date
2006-04-27
Last Posted Date
2006-10-11
Lead Sponsor
Aarhus University Hospital Skejby
Target Recruit Count
20
Registration Number
NCT00319293

To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
First Posted Date
2006-04-26
Last Posted Date
2017-03-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1091
Registration Number
NCT00318461
Locations
🇬🇧

Novo Nordisk Investigational Site, Sunbury on Thames, United Kingdom

Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Not Applicable
Conditions
Polycystic Ovary Syndrome
First Posted Date
2006-04-25
Last Posted Date
2006-10-11
Lead Sponsor
Aarhus University Hospital Skejby
Target Recruit Count
50
Registration Number
NCT00317928

A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Phase 2
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: GK Activator (2)
Drug: Metformin
First Posted Date
2006-04-21
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
259
Registration Number
NCT00316758

Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Phase 3
Completed
Conditions
Diabetes
Interventions
First Posted Date
2006-04-20
Last Posted Date
2015-04-29
Lead Sponsor
AstraZeneca
Target Recruit Count
365
Registration Number
NCT00316082
Locations
🇺🇸

Southland Clinical Research Center, Inc., Fountain Valley, California, United States

🇺🇸

Winston Technology, Inc., Haleyville, Alabama, United States

🇺🇸

Clinical Reseacrh Advantage/ Brown Family Medicine, Mesa, Arizona, United States

and more 48 locations

A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

Phase 3
Completed
Conditions
Diabetes
Interventions
First Posted Date
2006-04-12
Last Posted Date
2015-05-04
Lead Sponsor
AstraZeneca
Target Recruit Count
768
Registration Number
NCT00313313
Locations
🇺🇸

Stewart Medical Group, Alhambra, California, United States

🇺🇸

Valley Research, Fresno, California, United States

🇺🇸

Randall Shue, D.O., Los Angeles, California, United States

and more 52 locations

Metformin in Non-Alcoholic Fatty Liver Disease

Phase 2
Conditions
Fatty Liver
First Posted Date
2006-03-17
Last Posted Date
2007-07-02
Lead Sponsor
University Hospital, Aker
Target Recruit Count
90
Registration Number
NCT00303537
Locations
🇳🇴

Aker University Hospital, Oslo, Norway

🇳🇴

Haukeland Universitetssykehus, Bergen, Norway

🇳🇴

Universitetssykehuset i Nord-Norge, Tromsø, Norway

and more 1 locations

A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2006-02-24
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
565
Registration Number
NCT00295633
Locations
🇺🇸

Sunbelt Research Group, Llc, Mobile, Alabama, United States

🇺🇸

Loma Linda Va Healthcare Systems, Loma Linda, California, United States

🇺🇸

Mouhaffel, Assad H., West Monroe, Louisiana, United States

and more 77 locations

Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
First Posted Date
2006-02-13
Last Posted Date
2007-09-11
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
400
Registration Number
NCT00290940
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