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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
-

Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2004-11-22
Last Posted Date
2017-01-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
230
Registration Number
NCT00097279
Locations
🇺🇸

Novo Nordisk Investigational Site, Milwaukee, Wisconsin, United States

Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2004-07-05
Last Posted Date
2016-02-05
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
353
Registration Number
NCT00086502

Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type II
Interventions
First Posted Date
2004-07-05
Last Posted Date
2017-05-05
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
701
Registration Number
NCT00086515

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type II
Interventions
Drug: Metformin
Behavioral: Lifestyle Program
Drug: Rosiglitazone
First Posted Date
2004-04-12
Last Posted Date
2021-07-30
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
699
Registration Number
NCT00081328
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

George Washington University Biostatistics Center, Rockville, Maryland, United States

🇺🇸

Columbia University Medical Center, New York, New York, United States

and more 13 locations

Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

Phase 3
Completed
Conditions
Fatty Liver
Interventions
Drug: Matching placebo
Dietary Supplement: Vitamin E
Drug: Metformin
First Posted Date
2003-07-03
Last Posted Date
2012-09-27
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
173
Registration Number
NCT00063635
Locations
🇺🇸

University of California, San Diego, San Diego, California, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

and more 7 locations

Treating Nonalcoholic Steatohepatitis (NASH) With Metformin

Phase 2
Completed
Conditions
Hepatitis
First Posted Date
2003-06-24
Last Posted Date
2011-07-20
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
28
Registration Number
NCT00063232
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

Phase 3
Completed
Conditions
Diabetes Mellitus
First Posted Date
2002-10-02
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
240
Registration Number
NCT00046462
Locations
🇺🇸

Aventis, Bridgewater, New Jersey, United States

Diabetes Prevention Program Outcomes Study

Phase 3
Active, not recruiting
Conditions
Diabetes Mellitus
CVD
Cancer
Interventions
Behavioral: DPPOS Group Lifestyle
Behavioral: DPPOS Boost Lifestyle
Drug: Metformin
Behavioral: Intensive Lifestyle Group Session
First Posted Date
2002-06-05
Last Posted Date
2021-12-28
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
2779
Registration Number
NCT00038727
Locations
🇺🇸

George Washington University, Rockville, Maryland, United States

A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

Phase 3
Completed
Conditions
Diabetes Mellitus, Non-Insulin-Dependent
First Posted Date
2002-05-06
Last Posted Date
2011-04-15
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT00035542
Locations
🇺🇸

National Institute Of Clinical Research, Los Angeles, California, United States

🇺🇸

Driscoll Children's Hospital/Division of Medical Education/William Riley, Corpus Christi, Texas, United States

🇺🇸

Metro Health Medical Center, Cleveland, Ohio, United States

and more 47 locations

Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2002-03-22
Last Posted Date
2017-03-30
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
1791
Registration Number
NCT00032487
Locations
🇺🇸

Southern Arizona VA Health Care System, Tucson, Tucson, Arizona, United States

🇺🇸

VA Medical Center, Long Beach, Long Beach, California, United States

🇺🇸

Edward Hines, Jr. VA Hospital, Hines, Illinois, United States

and more 18 locations
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