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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
-

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

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
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

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
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

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Insulin monotherapy with premixed insulin NPH 30/70
Drug: Insulin Glargine
Drug: Glimepiride
Drug: Metformin
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

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
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
Obesity
Insulin Resistance
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

Phase 3
Completed
Conditions
Diabetes Mellitus
Interventions
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)

Phase 2
Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: MK-0941
Biological: Lantus
Drug: Metformin
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

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
First Posted Date
2008-10-01
Last Posted Date
2016-11-28
Lead Sponsor
Sanofi
Target Recruit Count
484
Registration Number
NCT00763815
Locations
🇺🇸

Sanofi-Aventis Investigational Site Number 840708, Kalamazoo, Michigan, United States

🇺🇸

Sanofi-Aventis Investigational Site Number 840792, Columbia, South Carolina, United States

🇺🇸

Sanofi-Aventis Investigational Site Number 840855, Mobile, Alabama, United States

and more 147 locations

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Metformin
First Posted Date
2008-10-01
Last Posted Date
2016-12-14
Lead Sponsor
Sanofi
Target Recruit Count
484
Registration Number
NCT00763451
Locations
🇺🇦

Sanofi-Aventis Administrative Office, Kiev, Ukraine

Safety and Efficacy of TAK-559 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus.

Phase 3
Terminated
Conditions
Diabetes Mellitus
Interventions
First Posted Date
2008-09-30
Last Posted Date
2012-02-28
Lead Sponsor
Takeda
Target Recruit Count
15
Registration Number
NCT00762957
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