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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, 50/50, and 30/70 in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2005-09-16
Last Posted Date
2017-01-05
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
603
Registration Number
NCT00184574
Locations
🇬🇧

Novo Nordisk Investigational Site, Watford, United Kingdom

Opposing Step-by-step Insulin Reinforcement to Intensified Strategy

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2005-09-15
Last Posted Date
2009-09-15
Lead Sponsor
Sanofi
Target Recruit Count
811
Registration Number
NCT00174642
Locations
🇬🇧

Sanofi-Aventis, Guildford, United Kingdom

Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of Metformin

Phase 3
Terminated
Conditions
Coronary and Peripheral Endothelial Dysfunction
First Posted Date
2005-09-15
Last Posted Date
2007-10-05
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
30
Registration Number
NCT00169624
Locations
🇫🇷

Laurent SEBBAG, Lyon, France

Metformin in Pregnant PCOS Women

Phase 3
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2005-09-12
Last Posted Date
2019-02-15
Lead Sponsor
Norwegian University of Science and Technology
Target Recruit Count
257
Registration Number
NCT00159536
Locations
🇳🇴

Central Hospital of Northern Norway, Bodø, Norway

🇳🇴

Ringerike Hospital, Hønefoss, Norway

🇳🇴

University hospital of Bergen, Bergen, Norway

and more 7 locations

Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

Phase 2
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Placebo
Drug: Metformin
Behavioral: Lifestyle Intervention
First Posted Date
2005-09-09
Last Posted Date
2018-03-21
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
114
Registration Number
NCT00151411
Locations
🇺🇸

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention

Not Applicable
Completed
Conditions
Obesity
Interventions
Drug: Metformin
Behavioral: Dietary modification with caloric restriction
Behavioral: Establishment of exercise protocol
First Posted Date
2005-08-31
Last Posted Date
2023-04-18
Lead Sponsor
Nemours Children's Clinic
Target Recruit Count
66
Registration Number
NCT00139477
Locations
🇺🇸

Nemours Children's Clinic, Jacksonville, Florida, United States

Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity

Phase 4
Completed
Conditions
Obesity
Interventions
First Posted Date
2005-08-24
Last Posted Date
2022-12-08
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
65
Registration Number
NCT00134303
Locations
🇧🇪

University Hospital Ghent, Ghent, Belgium

The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance

Phase 4
Completed
Conditions
Body Weight
Insulin Resistance
First Posted Date
2005-08-24
Last Posted Date
2007-12-28
Lead Sponsor
University Hospital, Ghent
Target Recruit Count
48
Registration Number
NCT00134290
Locations
🇧🇪

University Hospital Ghent, Ghent, Belgium

Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2005-08-19
Last Posted Date
2013-04-17
Lead Sponsor
Canadian Heart Research Centre
Target Recruit Count
391
Registration Number
NCT00131664
Locations
🇨🇦

Canadian Heart Research Centre, Toronto, Ontario, Canada

Insulin Resistance and Testosterone in Women

Phase 2
Completed
Conditions
Insulin Resistance
Postmenopause
Interventions
Drug: placebo pill
Drug: leuprolide injection
Drug: metformin
Drug: placebo injection
First Posted Date
2005-07-22
Last Posted Date
2019-05-23
Lead Sponsor
University of Pennsylvania
Target Recruit Count
35
Registration Number
NCT00123110
Locations
🇺🇸

University of Pennsylvania Clinical and Translational Research Center, Philadelphia, Pennsylvania, United States

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