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: C_₄H_₁₁N_₅

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: -

Clinical Trials

Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Duct Cell Adenocarcinoma of the Pancreas

Interventions: Drug: metformin hydrochloride
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Other: laboratory biomarker analysis

First Posted Date: 2012-08-16

Last Posted Date: 2021-08-10

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 50

Registration Number: NCT01666730

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Studying Changes in Breast Density in Patients With Early-Stage Breast Cancer Treated With Metformin Hydrochloride or Placebo on CAN-NCIC-MA.32

Conditions: Breast Cancer

First Posted Date: 2012-08-16

Last Posted Date: 2013-07-10

Lead Sponsor: Cancer and Leukemia Group B

Target Recruit Count: 458

Registration Number: NCT01666171

Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin

Phase 2

Terminated

Conditions: Insulin Resistance
Hypermetabolism
Hyperglycemia

Interventions: Drug: Metformin
Drug: Sugar pill

First Posted Date: 2012-08-16

Last Posted Date: 2019-11-29

Lead Sponsor: The University of Texas Medical Branch, Galveston

Target Recruit Count: 36

Registration Number: NCT01666665

Locations: 🇺🇸
Shriners Hospitals for Children, Galveston, Texas, United States

Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Phase 2

Conditions: Chronic Hepatitis c
Insulin Resistance

Interventions: Drug: metformin
Drug: pegylated-IFN
Drug: ribavirin

First Posted Date: 2012-08-14

Last Posted Date: 2012-08-14

Lead Sponsor: Kaohsiung Veterans General Hospital.

Target Recruit Count: 120

Registration Number: NCT01664845

Locations: 🇨🇳
Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: 50 mg PB1023
Drug: 70 mg PB1023
Other: Diet and Exercise
Drug: 100 mg PB1023
Drug: Metformin
Drug: Placebo (0.9% Sodium Chloride)
Drug: Victoza®
Drug: Metformin and Sulfonylurea
Drug: Sulfonylurea

First Posted Date: 2012-08-07

Last Posted Date: 2015-12-07

Lead Sponsor: PhaseBio Pharmaceuticals Inc.

Target Recruit Count: 593

Registration Number: NCT01658501

The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion

Not Applicable

Completed

Conditions: To Assess the Impact of Bile Acids on Human Glukagon-like-peptide-1 Secretion

Interventions: Drug: Acetaminophen
Other: Saline
Other: Cholecystokinin-8
Drug: Colesevelam
Drug: Metformin

First Posted Date: 2012-08-02

Last Posted Date: 2015-07-14

Lead Sponsor: Filip Krag Knop

Target Recruit Count: 10

Registration Number: NCT01656057

Locations: 🇩🇰
University Hospital of Copenhagen, Gentofte Hospital, Diabetic Research Division, Copenhagen, Hellerup, Denmark

The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Phase 4

Terminated

Conditions: Schizophrenia

Interventions: Drug: Placebo (for metformin)
Drug: Metformin

First Posted Date: 2012-08-01

Last Posted Date: 2018-09-07

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 15

Registration Number: NCT01654640

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis

Phase 4

Completed

Conditions: Liver Disease

Interventions: Dietary Supplement: Siliphos+ Selenium - Methionine + Alpha Lipoic Acid
Drug: Metformin

First Posted Date: 2012-07-26

Last Posted Date: 2014-08-20

Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Target Recruit Count: 50

Registration Number: NCT01650181

Locations: 🇲🇽
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico

Study of Erlotinib and Metformin in Triple Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Metformin
Drug: Erlotinib

First Posted Date: 2012-07-26

Last Posted Date: 2017-08-30

Lead Sponsor: Columbia University

Target Recruit Count: 8

Registration Number: NCT01650506

Locations: 🇺🇸
Columbia University, New York, New York, United States

A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Dulaglutide
Drug: Insulin glargine
Drug: Metformin
Drug: Sulfonylureas

First Posted Date: 2012-07-24

Last Posted Date: 2019-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 774

Registration Number: NCT01648582

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., Sankt-Petersburg, Russian Federation

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