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 Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country

Phase 2

Conditions: Gestational Diabetes
Type 2 Diabetes
Pregnancy

Interventions: Drug: Metformin
Drug: Insulin

First Posted Date: 2013-05-16

Last Posted Date: 2013-05-16

Lead Sponsor: Dow University of Health Sciences

Target Recruit Count: 300

Registration Number: NCT01855763

Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML

Phase 1

Terminated

Conditions: Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Erythroleukemia (M6a)
Blastic Phase Chronic Myelogenous Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Drug: metformin hydrochloride
Drug: cytarabine
Other: laboratory biomarker analysis

First Posted Date: 2013-05-08

Last Posted Date: 2019-01-31

Lead Sponsor: Northwestern University

Target Recruit Count: 2

Registration Number: NCT01849276

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Metformin

First Posted Date: 2013-04-29

Last Posted Date: 2017-12-22

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 25

Registration Number: NCT01842620

Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes

Phase 3

Terminated

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Fasiglifam (TAK-875) Placebo
Drug: Fasiglifam (TAK-875)
Drug: Sitagliptin Placebo
Drug: Sitagliptin
Drug: Metformin

First Posted Date: 2013-04-17

Last Posted Date: 2015-09-28

Lead Sponsor: Takeda

Target Recruit Count: 96

Registration Number: NCT01834274

Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

Phase 3

Completed

Conditions: Overweight
Autism Spectrum Disorder

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2013-04-08

Last Posted Date: 2018-02-22

Lead Sponsor: Evdokia Anagnostou

Target Recruit Count: 60

Registration Number: NCT01825798

Locations: 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States
🇺🇸
Ohio State University/Nationwide Children's Hospital, Columbus, Ohio, United States
🇨🇦
Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada

and more 1 locations