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
-

Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

First Posted Date
2006-08-10
Last Posted Date
2008-08-13
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
8
Registration Number
NCT00362765
Locations
🇮🇪

Site 3, Dublin, Ireland

🇫🇮

Site 2, Turku, Finland

🇮🇹

Site 1, Pisa, Italy

Insulin Glulisine in Type 2 Diabetic Patients

First Posted Date
2006-08-07
Last Posted Date
2011-08-08
Lead Sponsor
Sanofi
Target Recruit Count
106
Registration Number
NCT00360698
Locations
🇷🇺

Sanofi-Aventis, Moscow, Russian Federation

🇬🇧

Sanofi-aventis, Guildford, United Kingdom

AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-08-01
Last Posted Date
2009-05-18
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
544
Registration Number
NCT00359112
Locations
🇬🇧

GSK Investigational Site, Sheffield, United Kingdom

Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

Phase 4
Completed
Conditions
First Posted Date
2006-07-31
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
220
Registration Number
NCT00358124
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
First Posted Date
2006-07-19
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
100
Registration Number
NCT00353691
Locations
🇺🇸

Sanofi-Aventis, Bridgewater, New Jersey, United States

Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

First Posted Date
2006-07-11
Last Posted Date
2017-05-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
262
Registration Number
NCT00350779

Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

First Posted Date
2006-07-06
Last Posted Date
2017-03-01
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
301
Registration Number
NCT00348712
Locations
🇬🇧

Novo Nordisk Investigational Site, York, United Kingdom

Insulin Glargine in Type 2 Diabetic Patients

First Posted Date
2006-07-04
Last Posted Date
2009-09-15
Lead Sponsor
Sanofi
Target Recruit Count
387
Registration Number
NCT00347100
Locations
🇨🇳

Sanofi-Aventis, Beijing, China

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-06-02
Last Posted Date
2017-01-25
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
576
Registration Number
NCT00333151
Locations
🇨🇦

Novo Nordisk Investigational Site, Windsor, Canada

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
First Posted Date
2006-05-31
Last Posted Date
2017-01-26
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
584
Registration Number
NCT00331851
Locations
🇬🇧

Novo Nordisk Investigational Site, Watford, United Kingdom

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