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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
-

Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin

Phase 4
Completed
Conditions
PCOS
Obesity
Interventions
First Posted Date
2013-07-30
Last Posted Date
2013-07-30
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
36
Registration Number
NCT01911468
Locations
🇸🇮

University Medical Center Ljubljana, Ljubljana, Slovenia

Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer

Early Phase 1
Completed
Conditions
Endometrial Cancer
Interventions
First Posted Date
2013-07-30
Last Posted Date
2013-07-30
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
28
Registration Number
NCT01911247
Locations
🇺🇸

Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients

Phase 4
Terminated
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-07-29
Last Posted Date
2015-10-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
95
Registration Number
NCT01910441

Cardiovascular Effects of Metformin on Obesity

Phase 4
Withdrawn
Conditions
Insulin Resistance
Interventions
First Posted Date
2013-07-29
Last Posted Date
2018-12-11
Lead Sponsor
University of California, San Francisco
Registration Number
NCT01910246
Locations
🇺🇸

UCSF, Radiology and Biomedical Imaging, San Francisco, California, United States

Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer

Phase 3
Active, not recruiting
Conditions
Atypical Ductal Breast Hyperplasia
BRCA1 Mutation Carrier
Lobular Breast Carcinoma in Situ
BRCA2 Mutation Carrier
Ductal Breast Carcinoma in Situ
Interventions
First Posted Date
2013-07-23
Last Posted Date
2024-04-09
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
161
Registration Number
NCT01905046
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States

🇺🇸

Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States

and more 24 locations

Polycystic Ovary Syndrome and Liraglutide

Phase 4
Completed
Conditions
PCOS
Obesity
Interventions
First Posted Date
2013-07-15
Last Posted Date
2013-07-15
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
32
Registration Number
NCT01899430
Locations
🇸🇮

University Medical Center Ljubljana, Ljubljana, Slovenia

Triple Therapy in Type 2 Diabetic Patients

Phase 4
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-07-10
Last Posted Date
2013-07-10
Lead Sponsor
University of Pavia
Target Recruit Count
64
Registration Number
NCT01895569
Locations
🇮🇹

IRCCS Policlinico S. Matteo Foundation, Pavia, Italy

Incretin Effect in PCOS Women

Phase 4
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Drug: Metformin
Drug: Placebo
First Posted Date
2013-07-04
Last Posted Date
2020-11-27
Lead Sponsor
University Hospital, Gentofte, Copenhagen
Target Recruit Count
20
Registration Number
NCT01892254
Locations
🇩🇰

Copenhagen University Hospital Gentofte, Hellerup, Select A State, Denmark

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Metformin
Healthy Subjects
Interventions
First Posted Date
2013-06-24
Last Posted Date
2013-06-24
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01884558
Locations
🇺🇸

California Clinical Trials Medical Group, Glendale, California, United States

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