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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
-

Phase II Lung Metcore - Preoperative Metformin for Lung Cancer

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Lung Cancer
Interventions
First Posted Date
2017-03-22
Last Posted Date
2020-08-19
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
28
Registration Number
NCT03086733
Locations
🇨🇦

Toronto General Hospital, Toronto, Ontario, Canada

🇨🇦

Princess Margaret Hospital, Toronto, Ontario, Canada

Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Phase 4
Withdrawn
Conditions
Gestational Diabetes Mellitus, Class A2
Interventions
First Posted Date
2017-03-13
Last Posted Date
2018-05-04
Lead Sponsor
The University of Texas Health Science Center, Houston
Registration Number
NCT03078725

Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery

Phase 2
Active, not recruiting
Conditions
Pharynx
Larynx
LIP
Oral Cavity
Interventions
First Posted Date
2017-03-10
Last Posted Date
2018-12-24
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Target Recruit Count
7
Registration Number
NCT03076281
Locations
🇺🇸

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Metformin Plus TKI Use in Patients With Non-Small Cell Lung Carcinoma

Not Applicable
Conditions
Tyrosine Kinase Mutation
EGFR Gene Mutation
Non-Small Cell Adenocarcinoma
Interventions
First Posted Date
2017-03-07
Last Posted Date
2017-03-07
Lead Sponsor
Instituto Nacional de Cancerologia de Mexico
Target Recruit Count
120
Registration Number
NCT03071705
Locations
🇲🇽

Instituto National de Cancerologia, Mexico, Mexico

Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers

Phase 1
Completed
Conditions
Aging
Interventions
First Posted Date
2017-03-07
Last Posted Date
2019-04-01
Lead Sponsor
Anne Chang
Target Recruit Count
10
Registration Number
NCT03072485
Locations
🇺🇸

Stanford Dermatology, Redwood City, California, United States

Antidiabetic Effects on Intrahepatic Fat

Phase 4
Completed
Conditions
Non-Alcoholic Fatty Liver Disease
Type2 Diabetes
Interventions
First Posted Date
2017-03-01
Last Posted Date
2017-03-01
Lead Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Target Recruit Count
87
Registration Number
NCT03068065
Locations
🇨🇳

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, China

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: Sotagliflozin (SAR439954)
Drug: Metformin
Drug: Sulfonylurea
First Posted Date
2017-02-28
Last Posted Date
2021-05-11
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
507
Registration Number
NCT03066830
Locations
🇪🇪

Investigational Site Number 2333003, Parnu, Estonia

🇧🇬

Investigational Site Number 1003002, Ruse, Bulgaria

🇺🇦

Investigational Site Number 8043002, Kyiv, Ukraine

and more 73 locations

A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: DA-1241
Drug: Placebo
Drug: Metformin
First Posted Date
2017-02-23
Last Posted Date
2017-11-20
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
60
Registration Number
NCT03061981
Locations
🇺🇸

Early Phase Clinical Unit, Baltimore, Maryland, United States

Metformin in Intrahepatic Cholestasis of Pregnancy

Phase 2
Conditions
Pregnancy Complications
Intrahepatic Cholestases
Interventions
First Posted Date
2017-02-17
Last Posted Date
2018-07-26
Lead Sponsor
Epsom and St Helier University Hospitals NHS Trust
Target Recruit Count
40
Registration Number
NCT03056274

Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

Phase 2
Completed
Conditions
Rectal Neoplasm Carcinoma in Situ Adenocarcinoma
Interventions
First Posted Date
2017-02-15
Last Posted Date
2019-09-27
Lead Sponsor
Sunnybrook Health Sciences Centre
Target Recruit Count
15
Registration Number
NCT03053544
Locations
🇨🇦

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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