MedPath

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
C4H11N5
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
-

Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
First Posted Date
2008-01-14
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
164
Registration Number
NCT00592969
Locations
🇧🇷

Novo Nordisk Investigational Site, Santa Efigenia, Brazil

Genetic Variation in OCT1 and Response to Metformin

Phase 4
Withdrawn
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2008-01-08
Last Posted Date
2010-08-17
Lead Sponsor
Mayo Clinic
Registration Number
NCT00588172

Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type II
Interventions
First Posted Date
2007-12-20
Last Posted Date
2018-08-31
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
78
Registration Number
NCT00577590
Locations
🇺🇸

Washington University in St. Louis, Saint Louis, Missouri, United States

52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2007-12-18
Last Posted Date
2012-03-21
Lead Sponsor
AstraZeneca
Target Recruit Count
891
Registration Number
NCT00575588
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

Phase 3
Terminated
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2007-12-12
Last Posted Date
2021-05-26
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
94
Registration Number
NCT00571519

Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
First Posted Date
2007-12-06
Last Posted Date
2017-02-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
324
Registration Number
NCT00568984
Locations
🇹🇭

Novo Nordisk Investigational Site, Bangkok, Thailand

Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2007-11-21
Last Posted Date
2012-07-17
Lead Sponsor
Sanofi
Target Recruit Count
75
Registration Number
NCT00562172
Locations
🇰🇷

Sanofi-aventis, Seoul, Korea, Republic of

The Effect of Adding Metformin to the Treatment of Hepatitis C

Phase 4
Completed
Conditions
Hepatitis C
Interventions
Drug: Metformin
Drug: pegylated interferon
Drug: Ribavirin
First Posted Date
2007-11-20
Last Posted Date
2015-04-06
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
140
Registration Number
NCT00560690
Locations
🇮🇷

Shariati Hospital, Tehran, Iran, Islamic Republic of

Drug Interaction With Metformin

Phase 1
Completed
Conditions
Healthy Male and Female Subjects
Interventions
First Posted Date
2007-10-19
Last Posted Date
2016-12-20
Lead Sponsor
AstraZeneca
Target Recruit Count
18
Registration Number
NCT00546741
Locations
🇺🇸

Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes

Phase 4
Completed
Conditions
Impaired Glucose Tolerance
Interventions
First Posted Date
2007-10-19
Last Posted Date
2013-11-08
Lead Sponsor
St. Paul Heart Clinic
Target Recruit Count
50
Registration Number
NCT00546728
Locations
🇺🇸

International Diabetes Center at Park Nicollet, St. Louis Park, Minnesota, United States

🇺🇸

St. Paul Heart Clinic, St. Paul, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath