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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 Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-02-19
Last Posted Date
2024-11-06
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
412
Registration Number
NCT01071850
Locations
🇺🇸

CSRA Partners in Health, Inc., Augusta, Georgia, United States

🇺🇸

Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C., Tucker, Georgia, United States

🇮🇳

Bride, Bharti Hospital, Karnal, India

and more 56 locations

Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)

Completed
Conditions
Polycystic Ovarian Syndrome
Interventions
First Posted Date
2010-02-17
Last Posted Date
2020-03-30
Lead Sponsor
Yale University
Target Recruit Count
14
Registration Number
NCT01070160
Locations
🇺🇸

Yale-New Haven Hospital Women's Center, New Haven, Connecticut, United States

Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2010-02-15
Last Posted Date
2015-05-08
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT01068743
Locations
🇺🇸

PPD Development, LP, Austin, Texas, United States

Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-02-15
Last Posted Date
2017-01-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
403
Registration Number
NCT01068652
Locations
🇹🇳

Novo Nordisk Investigational Site, Tunisia, Tunisia

A Study in Participants With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-02-08
Last Posted Date
2015-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
978
Registration Number
NCT01064687
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., Yabucoa, Puerto Rico

Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo to Ertugliflozin
Drug: Ertugliflozin 5 mg
Drug: Placebo to Sitagliptin
Drug: Ertugliflozin 1 mg
Drug: Ertugliflozin 25 mg
Drug: Sitagliptin 100 mg
Drug: Metformin
First Posted Date
2010-02-01
Last Posted Date
2018-09-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
375
Registration Number
NCT01059825

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Dapagliflozin/Metformin
Drug: Dapagliflozin
Drug: Metformin
First Posted Date
2010-01-26
Last Posted Date
2012-06-01
Lead Sponsor
AstraZeneca
Target Recruit Count
120
Registration Number
NCT01055691
Locations
🇩🇪

Research Site, Berlin, Germany

A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

Phase 3
Terminated
Conditions
Diabetes Mellitus Type 2
Interventions
First Posted Date
2010-01-18
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
370
Registration Number
NCT01051011

Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes Type 2
Interventions
Drug: BMS-770767
Drug: Placebo
Drug: Metformin
First Posted Date
2010-01-12
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
76
Registration Number
NCT01046422
Locations
🇺🇸

Nevada Alliance Against Diabetes, Las Vegas, Nevada, United States

🇺🇸

Marina Raikhel, Md, Lomita, California, United States

🇰🇷

Local Institution, Suwon, Korea, Republic of

Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome

Phase 2
Conditions
Metabolic Syndrome
Interventions
Dietary Supplement: myo-inositol
Drug: Metformin
First Posted Date
2010-01-12
Last Posted Date
2014-05-20
Lead Sponsor
University of Messina
Target Recruit Count
100
Registration Number
NCT01046500
Locations
🇮🇹

University Hospital, Messina, Italy

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