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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
-

A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: Metformin
Drug: Placebo (matching sitagliptin)
Drug: Placebo (matching taspoglutide)
Drug: Sitagliptin
Drug: Taspoglutide
First Posted Date
2008-09-18
Last Posted Date
2016-11-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
666
Registration Number
NCT00754988

Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes Mellitus
Interventions
First Posted Date
2008-09-18
Last Posted Date
2010-07-05
Lead Sponsor
Takeda
Target Recruit Count
312
Registration Number
NCT00754403

Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

Phase 3
Withdrawn
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-09-18
Last Posted Date
2016-05-17
Lead Sponsor
Sanofi
Registration Number
NCT00754689
Locations
🇺🇸

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-09-11
Last Posted Date
2012-09-10
Lead Sponsor
Sanofi
Target Recruit Count
515
Registration Number
NCT00751114
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
First Posted Date
2008-09-03
Last Posted Date
2023-11-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
906
Registration Number
NCT00745433

A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
First Posted Date
2008-09-01
Last Posted Date
2016-08-05
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
326
Registration Number
NCT00744367

A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: LY2189265
Drug: Sitagliptin
Drug: Placebo tablet
Drug: Placebo solution
Drug: Metformin
First Posted Date
2008-08-14
Last Posted Date
2015-04-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1202
Registration Number
NCT00734474
Locations
🇨🇳

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yung-Kang, Tainan, Taiwan

Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-08-05
Last Posted Date
2020-12-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
317
Registration Number
NCT00728351
Locations
🇫🇷

Polycliniques des minguettes, Venissieux, France

🇩🇪

Malteser KM, Duisburg, Germany

🇩🇪

Diabeteszentrum Billstedt/Horn, Hamburg, Germany

and more 42 locations

Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.

Phase 3
Completed
Conditions
Diabetes Mellitus
Interventions
First Posted Date
2008-08-04
Last Posted Date
2011-07-29
Lead Sponsor
Takeda
Target Recruit Count
600
Registration Number
NCT00727857
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