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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
-

Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/metformin
Drug: Metformin
Drug: Linagliptin
First Posted Date
2012-04-20
Last Posted Date
2013-08-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
32
Registration Number
NCT01581931
Locations
🇩🇪

1288.20.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients

Phase 2
Completed
Conditions
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Interventions
First Posted Date
2012-04-18
Last Posted Date
2018-05-25
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
90
Registration Number
NCT01579812
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Study of Metformin Plus Paclitaxel/Carboplatin/Bevacizumab in Patients With Adenocarcinoma.

Phase 2
Terminated
Conditions
Carcinoma, Non-Small-Cell Lung
Lung Adenocarcinoma
Interventions
First Posted Date
2012-04-17
Last Posted Date
2018-12-19
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
25
Registration Number
NCT01578551
Locations
🇺🇸

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

🇺🇸

Johns Hopkins University SKCCC, Baltimore, Maryland, United States

A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)

Not Applicable
Completed
Conditions
Diabetes
Heart Failure
Interventions
First Posted Date
2012-04-10
Last Posted Date
2020-09-04
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
7
Registration Number
NCT01573949
Locations
🇺🇸

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

Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome
Insulin Resistance
Interventions
First Posted Date
2012-04-09
Last Posted Date
2013-12-30
Lead Sponsor
Chongqing Medical University
Target Recruit Count
40
Registration Number
NCT01573377
Locations
🇨🇳

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China

Metformin Plus Neoadjuvant Chemotherapy in Breast Cancer

Phase 2
Conditions
Locally Advanced Malignant Neoplasm
Interventions
First Posted Date
2012-03-29
Last Posted Date
2012-03-30
Lead Sponsor
Instituto Nacional de Cancerologia de Mexico
Target Recruit Count
60
Registration Number
NCT01566799
Locations
🇲🇽

Instituto Nacional Cancerologi, Mexico, Distrito Federal, Mexico

Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy

Phase 4
Conditions
Diabetes Mellitus Type II
Interventions
First Posted Date
2012-03-28
Last Posted Date
2012-03-28
Lead Sponsor
ikfe-CRO GmbH
Target Recruit Count
44
Registration Number
NCT01565096
Locations
🇩🇪

ikfe GmbH, Mainz, Germany

A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus

Phase 4
Completed
Conditions
Gestational Diabetes Mellitus
Interventions
First Posted Date
2012-03-26
Last Posted Date
2016-11-01
Lead Sponsor
HaEmek Medical Center, Israel
Target Recruit Count
108
Registration Number
NCT01563120
Locations
🇮🇱

Dep. OB/GYN, Emek Medical Center, Afula, Israel

Study of Metformin With Simvastatin for Men With Prostate Carcinoma

Phase 2
Withdrawn
Conditions
Prostate Carcinoma
Interventions
First Posted Date
2012-03-23
Last Posted Date
2015-07-22
Lead Sponsor
Nicholas Mitsiades
Registration Number
NCT01561482
Locations
🇺🇸

Baylor College of Medicine, Houston, Texas, United States

🇺🇸

Michael E. Debakey Veterans Affairs Medical Center, Houston, Texas, United States

🇺🇸

Ben Taub General Hospital, Houston, Texas, United States

A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Sitagliptin/metformin XR
Drug: Placebo
Drug: Metformin
Drug: Thyroid hormone
First Posted Date
2012-03-19
Last Posted Date
2020-10-28
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
25
Registration Number
NCT01557504
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