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

To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer
Solid Tumor

Interventions: Drug: Inavolisib
Drug: Letrozole
Drug: Fulvestrant
Drug: Trastuzumab
Drug: Palbociclib
Drug: Pertuzumab
Drug: Metformin

First Posted Date: 2016-12-30

Last Posted Date: 2024-12-20

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 200

Registration Number: NCT03006172

Locations: 🇺🇸
Massachusetts General Hospital., Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇪🇸
Hospital Universitari Vall d'Hebron, Barcelona, Spain

and more 10 locations

Effect of Linagliptin + Metformin vs Metformin Alone in Patients With Prediabetes

Phase 4

Completed

Conditions: Prediabetic State
Insulin Resistance

Interventions: Combination Product: Linagliptin + metformin
Drug: Metformin

First Posted Date: 2016-12-29

Last Posted Date: 2019-07-09

Lead Sponsor: Universidad de Guanajuato

Target Recruit Count: 144

Registration Number: NCT03004612

Locations: 🇲🇽
Universidad de Guanajuato, León, Guanajuato, Mexico

Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems

Phase 1

Conditions: Overweight
Abnormal Liver Function Tests

Interventions: Drug: Ursodeoxycholic acid
Drug: Placebo
Drug: Metformin

First Posted Date: 2016-12-21

Last Posted Date: 2016-12-23

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 30

Registration Number: NCT03000218

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

Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer

Phase 2

Conditions: Endometrial Cancer

Interventions: Drug: Metformin
Device: Mirena®

First Posted Date: 2016-12-13

Last Posted Date: 2016-12-13

Lead Sponsor: Chang Gung Memorial Hospital

Target Recruit Count: 120

Registration Number: NCT02990728

Genomic Outcomes of Metformin

Phase 4

Completed

Conditions: Coronary Artery Disease
Mild Cognitive Impairment
Obesity, Abdominal
Hypertension

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2016-12-08

Last Posted Date: 2023-11-18

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 30

Registration Number: NCT02986659

Locations: 🇺🇸
Wake Forest Health Sciences, Winston-Salem, North Carolina, United States

Extended-release vs Immediate-release Metformin in PCOS Women

Not Applicable

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin

First Posted Date: 2016-12-07

Last Posted Date: 2016-12-07

Lead Sponsor: Catholic University of the Sacred Heart

Target Recruit Count: 80

Registration Number: NCT02984722

Locations: 🇮🇹
Catholic university of Sacred Heart, Rome, Italy

The Potential Hepatoprotective Effect of Metformin in Patients With Beta Thalassemia Major

Phase 4

Conditions: Beta Thalassemia Major Anemia

Interventions: Drug: Metformin

First Posted Date: 2016-12-07

Last Posted Date: 2018-07-18

Lead Sponsor: Cairo University

Target Recruit Count: 60

Registration Number: NCT02984475

Locations: 🇪🇬
Abo El Reesh Hospital, Cairo., Egypt
🇪🇬
El Demerdash (Ain Shams Teaching Hospital)., Cairo., Egypt

Fetal Hemoglobin Induction Treatment Metformin

Early Phase 1

Completed

Conditions: Hemoglobin Disorder
Sickle Cell Anemia
Sickle Cell Disease

Interventions: Drug: Metformin
Behavioral: Questionnaires

First Posted Date: 2016-12-05

Last Posted Date: 2023-10-12

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 37

Registration Number: NCT02981329

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States