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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 Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

Phase 3
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2009-12-17
Last Posted Date
2017-05-30
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
30
Registration Number
NCT01034111

30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)

First Posted Date
2009-12-09
Last Posted Date
2017-05-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
317
Registration Number
NCT01028391

The Effects of Oral Hypoglycemic Agents on Chronic Hepatitis C Patients Receiving Peg-Intron Plus Ribavirin

Phase 4
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2009-12-04
Last Posted Date
2012-11-27
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
80
Registration Number
NCT01025765
Locations
🇨🇳

National Taiwan University Hospital Department of Internal Medicine,, Taipei, Taiwan

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2009-12-02
Last Posted Date
2013-03-26
Lead Sponsor
Takeda
Target Recruit Count
784
Registration Number
NCT01023581

Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2009-11-03
Last Posted Date
2012-01-19
Lead Sponsor
AstraZeneca
Target Recruit Count
286
Registration Number
NCT01006590
Locations
🇬🇧

Research Site, Peterborough, United Kingdom

Drug Interaction Between CKD-501 and Metformin

Phase 1
Completed
Conditions
Healthy Male Volunteers
Interventions
Drug: Metformin
Drug: CKD-501
First Posted Date
2009-10-30
Last Posted Date
2011-01-12
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
24
Registration Number
NCT01005160

Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
First Posted Date
2009-10-27
Last Posted Date
2016-10-17
Lead Sponsor
AstraZeneca
Target Recruit Count
15
Registration Number
NCT01002807
Locations
🇺🇸

Ppd Development, Lp, Austin, Texas, United States

Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics

Phase 4
Conditions
Type II Diabetes
Hypertension
Interventions
First Posted Date
2009-10-27
Last Posted Date
2015-04-07
Lead Sponsor
Aristotle University Of Thessaloniki
Target Recruit Count
1054
Registration Number
NCT01001962
Locations
🇬🇷

Hypertension 24h ABPM center Papageorgiou Hospital, Thessaloniki, Greece

The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)

Phase 3
Completed
Conditions
Polycystic Ovary Syndrome
Miscarriage
Infertility
Toxemia
Gestational Diabetes
Interventions
First Posted Date
2009-10-14
Last Posted Date
2010-02-23
Lead Sponsor
University of Oulu
Target Recruit Count
326
Registration Number
NCT00994812
Locations
🇫🇮

University Hospital of Kuopio, Kuopio, Finland

🇫🇮

University Hopsital of Oulu, Oulu, Finland

🇫🇮

University Hospital of Tampere, Tampere, Finland

and more 2 locations

Effects of Metformin and Oral Hormonal Contraceptive in Adolescents With Polycystic Ovary Syndrome

Not Applicable
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Metformin
Drug: Placebo
First Posted Date
2009-10-01
Last Posted Date
2012-06-26
Lead Sponsor
Federal University of São Paulo
Target Recruit Count
90
Registration Number
NCT00988078
Locations
🇧🇷

Federal University of Sao Paulo, Sao Paulo, Brazil

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