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

A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007).

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo to Ertugliflozin
Drug: Ertugliflozin 5 mg
Drug: Ertugliflozin 15 mg
Drug: Placebo to Glimepiride
Other: Glimepiride
Biological: Basal Insulin
Drug: Metformin

First Posted Date: 2014-01-13

Last Posted Date: 2018-09-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 621

Registration Number: NCT02033889

Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk

Phase 2

Completed

Conditions: Breast Cancer Prevention

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2014-01-07

Last Posted Date: 2023-06-27

Lead Sponsor: University of Arizona

Target Recruit Count: 151

Registration Number: NCT02028221

Locations: 🇺🇸
University of Arizona, Tucson, Arizona, United States

Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: INSULIN GLARGINE
Drug: Metformin
Drug: DPP-4 inhibitor
Drug: Sulphonylurea

First Posted Date: 2014-01-06

Last Posted Date: 2015-08-27

Lead Sponsor: Sanofi

Target Recruit Count: 109

Registration Number: NCT02027753

Locations: 🇰🇷
Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of

Vaginal Administration of Metformin in PCOS Patients.

Early Phase 1

Conditions: PCOS

Interventions: Drug: Metformin

First Posted Date: 2014-01-03

Last Posted Date: 2014-01-03

Lead Sponsor: Assiut University

Target Recruit Count: 200

Registration Number: NCT02026869

Locations: 🇪🇬
Women's Health Hospital, Assiut, Egypt

Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: Pioglitazone

First Posted Date: 2014-01-03

Last Posted Date: 2014-01-03

Lead Sponsor: Tehran University of Medical Sciences

Target Recruit Count: 102

Registration Number: NCT02027103

Locations: 🇮🇷
Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

Phase 1

Completed

Conditions: Diabetes
Healthy
Diabetes Mellitus, Type 2

Interventions: Drug: semaglutide
Drug: placebo
Drug: metformin
Drug: warfarin

First Posted Date: 2013-12-27

Last Posted Date: 2017-04-04

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 24

Registration Number: NCT02022254

Locations: 🇩🇪
Novo Nordisk Investigational Site, Berlin, Germany

A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes

Phase 1

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Exenatide ER
Drug: LY3053102
Drug: Placebo
Drug: Metformin

First Posted Date: 2013-12-25

Last Posted Date: 2019-10-08

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 60

Registration Number: NCT02020616

Locations: 🇺🇸
Orange County Research Center, Orange, California, United States
🇺🇸
Compass Research, Orlando, Florida, United States
🇺🇸
Clinilabs, Inc (New York), New York, New York, United States

and more 2 locations

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer Stage IIIB/IV
Nonsquamous Nonsmall Cell Neoplasm of Lung
Non-small Cell Lung Cancer Metastatic

Interventions: Drug: metformin
Behavioral: carbohydrate restricted diet

First Posted Date: 2013-12-24

Last Posted Date: 2018-05-04

Lead Sponsor: Beth Israel Medical Center

Target Recruit Count: 14

Registration Number: NCT02019979

Locations: 🇺🇸
Beth Israel Medical Center, New York, New York, United States
🇺🇸
Beth Israel Comprehensive Cancer Center, New York, New York, United States
🇺🇸
Mount Sinai Ichan School of Medicine, New York, New York, United States

and more 1 locations