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

Spironolactone Plus Metformin in Polycystic Ovary Syndrome

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin
Drug: Metformin plus Spironolactone

First Posted Date: 2012-02-06

Last Posted Date: 2012-02-06

Lead Sponsor: University Magna Graecia

Target Recruit Count: 56

Registration Number: NCT01526616

Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: BMS-754807 (IGR-IR/IR Inhibitor)
Drug: Metformin

First Posted Date: 2012-02-03

Last Posted Date: 2012-06-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 26

Registration Number: NCT01525823

Locations: 🇦🇺
Local Institution, Melbourne, Victoria, Australia

FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Insulin Glargine
Drug: Metformin
Drug: Prandial insulin
Drug: Exenatide

First Posted Date: 2012-02-02

Last Posted Date: 2023-12-29

Lead Sponsor: University of Washington

Target Recruit Count: 102

Registration Number: NCT01524705

Locations: 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
Joslin Diabetes Center, Boston, Massachusetts, United States
🇺🇸
University of Washington, Seattle, Washington, United States

and more 9 locations

Metformin Effects on Oxidative Stress Parameters in Newly Diagnosed Type 2 Diabetes Patients

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin

First Posted Date: 2012-01-30

Last Posted Date: 2012-01-31

Lead Sponsor: Tehran University of Medical Sciences

Target Recruit Count: 108

Registration Number: NCT01521624

Locations: 🇮🇷
Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

Phase 4

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: biphasic insulin aspart 30
Drug: sitagliptin
Drug: metformin

First Posted Date: 2012-01-27

Last Posted Date: 2017-02-24

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 582

Registration Number: NCT01519674

Locations: 🇹🇷
Novo Nordisk Investigational Site, Istanbul, Turkey

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide (AVE0010)
Device: Self-injector pen device (OptiClik®)
Drug: Metformin

First Posted Date: 2012-01-25

Last Posted Date: 2016-10-14

Lead Sponsor: Sanofi

Target Recruit Count: 451

Registration Number: NCT01517412

Locations: 🇨🇿
Investigational Site Number 203104, Plzen, Czech Republic
🇵🇱
Investigational Site Number 616106, Bytom, Poland
🇵🇱
Investigational Site Number 616105, Wroclaw, Poland

and more 79 locations

Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Vildagliptin/ Metformin
Drug: Liraglutide
Drug: Metformin

First Posted Date: 2012-01-25

Last Posted Date: 2017-02-27

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 62

Registration Number: NCT01518101

Locations: 🇩🇪
Novartis Investigative Site, Völlkingen, Germany

Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: linagliptin
Drug: metformin
Drug: metformin placebo

First Posted Date: 2012-01-20

Last Posted Date: 2014-05-20

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 316

Registration Number: NCT01512979

Locations: 🇺🇸
1218.83.11022 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States
🇺🇸
1218.83.11013 Boehringer Ingelheim Investigational Site, Jacksonville, North Carolina, United States
🇺🇸
1218.83.11017 Boehringer Ingelheim Investigational Site, Chattanooga, Tennessee, United States

and more 79 locations