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

Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets

Phase 4

Withdrawn

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: Glucophage

First Posted Date: 2012-01-16

Last Posted Date: 2014-02-04

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Registration Number: NCT01510522

Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin
Drug: Glimepiride

First Posted Date: 2012-01-12

Last Posted Date: 2012-01-16

Lead Sponsor: University of Sao Paulo

Target Recruit Count: 20

Registration Number: NCT01509001

Locations: 🇧🇷
Clinical Hospital of São Paulo Medical School, são Paulo, SP, Brazil

A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients

Phase 3

Completed

Conditions: Type II Diabetes Mellitus

Interventions: Drug: ASP1941
Drug: metformin
Drug: Placebo

First Posted Date: 2012-01-06

Last Posted Date: 2024-11-11

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 171

Registration Number: NCT01505426

Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers

Phase 1

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: repaglinide
Drug: metformin
Drug: repaglinide and metformin combination tablet

First Posted Date: 2011-12-13

Last Posted Date: 2017-02-10

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 93

Registration Number: NCT01490658

Locations: 🇺🇸
Novo Nordisk Investigational Site, Austin, Texas, United States

Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Healthy Volunteers

Phase 1

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: repaglinide
Drug: metformin
Drug: repaglinide and metformin combination tablet

First Posted Date: 2011-12-09

Last Posted Date: 2017-02-10

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 62

Registration Number: NCT01489644

Locations: 🇺🇸
Novo Nordisk Investigational Site, Tacoma, Washington, United States

Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer

Phase 1

Completed

Conditions: Stage IV Pancreatic Cancer

Interventions: Drug: Gemcitabine
Drug: nab-paclitaxel
Drug: FOLFIRINOX
Genetic: Immunohistochemistry (IHC) Analysis
Drug: Metformin
Drug: mFOLFIRI

First Posted Date: 2011-12-08

Last Posted Date: 2016-08-18

Lead Sponsor: Pancreatic Cancer Research Team

Target Recruit Count: 60

Registration Number: NCT01488552

Locations: 🇺🇸
Evergreen Hematology and Oncology, Spokane, Washington, United States
🇺🇸
Disney Family Cancer Center, Burbank, California, United States
🇺🇸
Virginia Mason Medical Center, Seattle, Washington, United States

and more 2 locations