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

Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics

Phase 4

Conditions: Type II Diabetes
Hypertension

Interventions: Drug: Metformin
Drug: empagliflozin

First Posted Date: 2009-10-27

Last Posted Date: 2015-04-07

Lead Sponsor: Aristotle University Of Thessaloniki

Target Recruit Count: 1054

Registration Number: NCT01001962

Locations: 🇬🇷
Hypertension 24h ABPM center Papageorgiou Hospital, Thessaloniki, Greece

The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)

Phase 3

Completed

Conditions: Polycystic Ovary Syndrome
Miscarriage
Infertility
Toxemia
Gestational Diabetes

Interventions: Drug: metformin

First Posted Date: 2009-10-14

Last Posted Date: 2010-02-23

Lead Sponsor: University of Oulu

Target Recruit Count: 326

Registration Number: NCT00994812

Locations: 🇫🇮
University Hospital of Kuopio, Kuopio, Finland
🇫🇮
University Hopsital of Oulu, Oulu, Finland
🇫🇮
University Hospital of Tampere, Tampere, Finland

and more 2 locations

Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome

Not Applicable

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2009-10-01

Last Posted Date: 2012-06-26

Lead Sponsor: Federal University of São Paulo

Target Recruit Count: 90

Registration Number: NCT00988078

Locations: 🇧🇷
Federal University of Sao Paulo, Sao Paulo, Brazil

Metformin Hydrochloride in Treating Women With Stage I or Stage II Breast Cancer That Can Be Removed By Surgery

Not Applicable

Terminated

Conditions: Breast Cancer

Interventions: Drug: metformin hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2009-09-25

Last Posted Date: 2024-02-01

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 5

Registration Number: NCT00984490

Locations: 🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸
Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide Placebo
Drug: Lixisenatide (AVE0010)
Device: Pen auto-injector
Drug: Sitagliptin Placebo
Drug: Sitagliptin
Drug: Metformin

First Posted Date: 2009-09-15

Last Posted Date: 2016-10-11

Lead Sponsor: Sanofi

Target Recruit Count: 319

Registration Number: NCT00976937

Locations: 🇺🇸
Sanofi-Aventis Investigational Site Number 840004, Medford, Oregon, United States
🇺🇸
Sanofi-Aventis Investigational Site Number 840003, Muscle Shoals, Alabama, United States
🇺🇸
Sanofi-Aventis Investigational Site Number 840006, Butte, Montana, United States

and more 89 locations

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Insulin glargine
Device: Pen auto-injector
Drug: Metformin
Drug: Thiazolidinedione (TZD)

First Posted Date: 2009-09-11

Last Posted Date: 2016-10-11

Lead Sponsor: Sanofi

Target Recruit Count: 446

Registration Number: NCT00975286

Locations: 🇺🇸
Sanofi-Aventis Investigational Site Number 840210, Dallas, Texas, United States
🇺🇸
Sanofi-Aventis Investigational Site Number 840211, Baton Rouge, Louisiana, United States
🇺🇸
Sanofi-Aventis Investigational Site Number 840230, Hyattsville, Maryland, United States

and more 137 locations

Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

Phase 1

Completed

Conditions: Neuropathic Pain

Interventions: Drug: Metformin
Drug: Eslicarbazepine acetate

First Posted Date: 2009-09-03

Last Posted Date: 2014-12-16

Lead Sponsor: Bial - Portela C S.A.

Target Recruit Count: 20

Registration Number: NCT00971295

Locations: 🇵🇹
Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA,, Mamede do Coronado, Portugal