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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 โ‰ฅ10 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
-

Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

Phase 4
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2008-05-19
Last Posted Date
2008-05-19
Lead Sponsor
Hospital Privado de Cordoba, Argentina
Target Recruit Count
30
Registration Number
NCT00679679
Locations
๐Ÿ‡ฆ๐Ÿ‡ท

Hospital Privado de Cรณrdoba, Cordoba, Argentina

Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-05-19
Last Posted Date
2018-04-18
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
226
Registration Number
NCT00679939
Locations
๐Ÿ‡ช๐Ÿ‡ธ

GSK Investigational Site, Petrer, Spain

Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes

Not Applicable
Completed
Conditions
Pregnancy Complications
Interventions
Drug: Metformin
Drug: Insulin (NPH and Regular)
First Posted Date
2008-05-15
Last Posted Date
2018-11-28
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
25
Registration Number
NCT00678080
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Valley Baptist Hospital, Brownsville, Texas, United States

๐Ÿ‡บ๐Ÿ‡ธ

Memorial Hermann Hospital, Houston, Texas, United States

๐Ÿ‡บ๐Ÿ‡ธ

Lyndon B Johnson Hospital, Houston, Texas, United States

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-05-13
Last Posted Date
2015-04-09
Lead Sponsor
AstraZeneca
Target Recruit Count
820
Registration Number
NCT00676338
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Research Site, Swansea, United Kingdom

๐Ÿ‡ฎ๐Ÿ‡ฑ

Research SIte, Tel-Hashomer, Israel

Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED)

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: SCH 497079
Drug: Placebo
Drug: Metformin
First Posted Date
2008-05-07
Last Posted Date
2018-09-10
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
17
Registration Number
NCT00673465

A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes Mellitus
Endocrine System Diseases
Nutritional and Metabolic Diseases
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo
Drug: JNJ16269110
Drug: Metformin
Other: Dietary Counseling
First Posted Date
2008-05-06
Last Posted Date
2014-07-14
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
352
Registration Number
NCT00672386

Cardio Risk of Acute Schizophrenia Olanzapine Duke

Phase 4
Withdrawn
Conditions
Schizophrenia
Schizoaffective Disorder
Interventions
First Posted Date
2008-05-06
Last Posted Date
2014-07-31
Lead Sponsor
Duke University
Registration Number
NCT00672464
Locations
๐Ÿ‡บ๐Ÿ‡ธ

John Umstead Hospital, Butner, North Carolina, United States

๐Ÿ‡บ๐Ÿ‡ธ

Duke University Medical Center, Durham, North Carolina, United States

Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
First Posted Date
2008-05-02
Last Posted Date
2014-05-21
Lead Sponsor
University of Michigan
Target Recruit Count
14
Registration Number
NCT00670800
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Michigan, Michigan Clinical Research Unit, Ann Arbor, Michigan, United States

Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-05-01
Last Posted Date
2016-04-01
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
293
Registration Number
NCT00669864

Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance

Phase 4
Completed
Conditions
Pediatric Obesity
Insulin Resistance
Hyperinsulinemia
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2008-04-28
Last Posted Date
2009-02-18
Lead Sponsor
Yale University
Target Recruit Count
28
Registration Number
NCT00667498
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Yale Center for Clinical Investigation (YCCI), New Haven, Connecticut, United States

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