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

Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery

Phase 1

Withdrawn

Conditions: Stage IA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer

Interventions: Drug: metformin hydrochloride
Other: pharmacological study

First Posted Date: 2013-10-07

Last Posted Date: 2015-07-15

Lead Sponsor: Case Comprehensive Cancer Center

Registration Number: NCT01954732

Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Jentadueto®.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Metformin
Drug: Linagliptin

First Posted Date: 2013-09-20

Last Posted Date: 2015-02-25

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 36

Registration Number: NCT01947153

Locations: 🇷🇺
1288.21.1 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: DA-1229
Drug: metformin
Drug: DA-1229 + metformin

First Posted Date: 2013-09-13

Last Posted Date: 2013-11-27

Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Target Recruit Count: 36

Registration Number: NCT01941199

Locations: 🇰🇷
Clinical Trial Center, Seoul National University Hospital, Seoul, Korea, Republic of

Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes

Phase 2

Completed

Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

Interventions: Drug: Pioglitazone
Drug: Metformin

First Posted Date: 2013-09-05

Last Posted Date: 2014-06-17

Lead Sponsor: King Abdulaziz University

Target Recruit Count: 440

Registration Number: NCT01935804

Locations: 🇸🇦
Center of Excellence for Osteoporosis Research, King Abdulaziz University, Jeddah, Makkah, Saudi Arabia

Metformin Plus Irinotecan for Refractory Colorectal Cancer

Phase 2

Conditions: Adenocarcinoma
Colorectal Neoplasms

Interventions: Drug: metformin
Drug: irinotecan

First Posted Date: 2013-08-29

Last Posted Date: 2017-06-22

Lead Sponsor: Barretos Cancer Hospital

Target Recruit Count: 41

Registration Number: NCT01930864

Locations: 🇧🇷
Barretos Cancer Hospital, Barretos, SP, Brazil
🇧🇷
State University of Campinas, Campinas, São Paulo, Brazil

NeoMET Study in Neoadjuvant Treatment of Breast Cancer

Phase 2

Terminated

Conditions: pCR Rate
BCT Rate
Safety

Interventions: Drug: Metformin
Drug: Docetaxel
Drug: Epirubicin
Drug: cyclophosphomide

First Posted Date: 2013-08-28

Last Posted Date: 2022-04-06

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 92

Registration Number: NCT01929811

Locations: 🇨🇳
Linyi People's Hospital, Linyi, Shandong, China
🇨🇳
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China