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
-

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

First Posted Date
2008-11-25
Last Posted Date
2014-01-28
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
857
Registration Number
NCT00798161
Locations
🇨🇦

1218.46.11003 Boehringer Ingelheim Investigational Site, Edmonton, Alberta, Canada

🇨🇦

1218.46.11002 Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada

🇨🇦

1218.46.11006 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada

and more 135 locations

PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

First Posted Date
2008-11-21
Last Posted Date
2008-11-21
Lead Sponsor
University of Auckland, New Zealand
Target Recruit Count
171
Registration Number
NCT00795808
Locations
🇳🇿

University of Auckland, Auckland, New Zealand

A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)

First Posted Date
2008-11-18
Last Posted Date
2015-12-17
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
143
Registration Number
NCT00792935

12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients

Phase 2
Completed
Conditions
First Posted Date
2008-11-11
Last Posted Date
2014-06-18
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
408
Registration Number
NCT00789035
Locations
🇩🇪

1245.9.49004 Boehringer Ingelheim Investigational Site, Hamburg, Germany

🇮🇹

1245.9.39004 Boehringer Ingelheim Investigational Site, Siena, Italy

🇦🇷

1245.9.54001 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

and more 71 locations

Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

First Posted Date
2008-11-11
Last Posted Date
2017-03-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
222
Registration Number
NCT00789191
Locations
🇹🇷

Novo Nordisk Investigational Site, Kocaeli, Turkey

Insulin Glargine Combination Therapies in Type II Diabetics

First Posted Date
2008-11-02
Last Posted Date
2009-09-28
Lead Sponsor
Sanofi
Target Recruit Count
375
Registration Number
NCT00783744
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford, United Kingdom

🇦🇹

Sanofi aventis administrative office, Vienna, Austria

🇫🇷

Sanofi-aventis administrative office, Paris, France

Response To Oral Agents in Diabetes (ROAD)- Pilot Study

First Posted Date
2008-10-28
Last Posted Date
2017-10-26
Lead Sponsor
University of Dundee
Target Recruit Count
29
Registration Number
NCT00780715
Locations
🇬🇧

Ninewells Hospital & Medical School, Dundee, United Kingdom

Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2008-10-20
Last Posted Date
2012-08-31
Lead Sponsor
University of Minnesota
Registration Number
NCT00775164

Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes

First Posted Date
2008-10-15
Last Posted Date
2010-07-05
Lead Sponsor
Takeda
Target Recruit Count
418
Registration Number
NCT00772174

Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

First Posted Date
2008-10-06
Last Posted Date
2015-02-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
813
Registration Number
NCT00767000
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