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

Efficacy and Safety of Alogliptin Combined With Metformin in Participants With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Alogliptin and metformin
Drug: Metformin

First Posted Date: 2006-02-03

Last Posted Date: 2012-02-03

Lead Sponsor: Takeda

Target Recruit Count: 527

Registration Number: NCT00286442

Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy

Phase 3

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin
Drug: Oral Contraceptive Pill
Behavioral: Quality of Life Questionnaire
Behavioral: Lifestyle Management Program
Procedure: Oral Glucose Tolerance Test
Procedure: Blood work
Procedure: Abdominal Ultra Sound
Procedure: Dual-energy x-ray absorptiometry (DEXA scan)
Drug: placebo

First Posted Date: 2006-01-30

Last Posted Date: 2015-05-15

Lead Sponsor: University of Rochester

Target Recruit Count: 36

Registration Number: NCT00283816

Locations: 🇺🇸
University of Rochester Medical Center, Rochester, New York, United States

Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone

Not Applicable

Terminated

Conditions: Type 2 Diabetes Mellitus

First Posted Date: 2006-01-27

Last Posted Date: 2008-10-13

Lead Sponsor: Pfizer

Target Recruit Count: 29

Registration Number: NCT00282945

Locations: 🇮🇱
Pfizer Investigational Site, Jerusalem, Israel

Life Style Modifications Prevents Type 2 Diabetes in Asian Indians

Phase 1

Completed

Conditions: Diabetes

First Posted Date: 2006-01-19

Last Posted Date: 2006-01-24

Lead Sponsor: M.V. Hospital for Diabetes

Registration Number: NCT00279240

Locations: 🇮🇳
Diabetes Research Centre & MV Hospital for Diabetes, Chennai, Tamilnadu, India

Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

First Posted Date: 2006-01-19

Last Posted Date: 2017-11-29

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 4426

Registration Number: NCT00279045

Locations: 🇬🇧
GSK Investigational Site, Wigan, United Kingdom

ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Insulin glulisine
Drug: Insulin glargine
Drug: Metformin

First Posted Date: 2006-01-04

Last Posted Date: 2009-12-07

Lead Sponsor: Sanofi

Target Recruit Count: 352

Registration Number: NCT00272064

Locations: 🇮🇹
Sanofi-Aventis Administrative Office, Milan, Italy

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Transdermal Oestradiol
Drug: Prednisolone
Drug: Celecoxib
Drug: Docetaxel
Drug: ADT
Radiation: Radiotherapy to the prostate
Drug: Zoledronic Acid
Drug: Metformin
Drug: Abiraterone
Drug: Enzalutamide

First Posted Date: 2005-12-22

Last Posted Date: 2023-04-18

Lead Sponsor: Medical Research Council

Target Recruit Count: 11992

Registration Number: NCT00268476

Locations: 🇬🇧
West Suffolk Hospital, Bury St. Edmunds, England, United Kingdom
🇬🇧
Derbyshire Royal Infirmary, Derby, England, United Kingdom
🇬🇧
Russells Hall Hospital, Dudley, England, United Kingdom

and more 115 locations