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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 to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2010-06-02
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
168
Registration Number
NCT01135433

Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
First Posted Date
2010-05-26
Last Posted Date
2022-09-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1147
Registration Number
NCT01131182

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: LY2189265
Drug: Metformin
Drug: Placebo (oral)
Drug: Placebo (subcutaneous)
First Posted Date
2010-05-19
Last Posted Date
2015-01-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
807
Registration Number
NCT01126580
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., Nottingham, United Kingdom

Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Completed
Conditions
Acanthosis Nigricans
Hyperinsulinemia
Spectroscopic Analysis
First Posted Date
2010-05-18
Last Posted Date
2012-09-06
Lead Sponsor
Henry Ford Health System
Target Recruit Count
9
Registration Number
NCT01125150
Locations
🇺🇸

Department of Dermatology, NEW CENTER ONE, Detroit, Michigan, United States

Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-05-14
Last Posted Date
2017-02-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
521
Registration Number
NCT01123980
Locations
🇯🇵

Novo Nordisk Investigational Site, Yokohama-shi, Japan

Management of Diabetes With Metformin In Patients With Chronic Heart Failure

Not Applicable
Completed
Conditions
Heart Failure
Diabetes
Interventions
First Posted Date
2010-05-13
Last Posted Date
2020-09-04
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
10
Registration Number
NCT01122316
Locations
🇺🇸

Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, California, United States

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-05-05
Last Posted Date
2014-04-11
Lead Sponsor
Sanofi
Target Recruit Count
978
Registration Number
NCT01117350
Locations
🇺🇸

Investigational Site Number 840026, Longmont, Colorado, United States

🇺🇸

Investigational Site Number 840007, Dallas, Texas, United States

🇺🇸

Investigational Site Number 840020, Uniontown, Pennsylvania, United States

and more 133 locations

A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2010-05-05
Last Posted Date
2024-11-06
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
343
Registration Number
NCT01117584

Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: BMS-823778
Drug: Placebo
Drug: Metformin
First Posted Date
2010-04-28
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
62
Registration Number
NCT01111955
Locations
🇺🇸

Capital Clinical Reserch Center, Olympia, Washington, United States

🇺🇸

Farid Marquez, Md, Hialeah, Florida, United States

🇨🇦

Local Institution, Quebec, Canada

and more 1 locations

The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-04-20
Last Posted Date
2013-07-15
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
344
Registration Number
NCT01106690
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