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 Pharmacokinetics in Patients With Chronic and Acute Heart Failure

Phase 4

Conditions: Heart Failure, Systolic

Interventions: Other: Blood draws and urine samples for metformin concentration measurements
Drug: Metformin

First Posted Date: 2016-06-13

Last Posted Date: 2018-04-20

Lead Sponsor: Aarhus University Hospital

Target Recruit Count: 110

Registration Number: NCT02797340

Locations: 🇩🇰
Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark

MEtformin and Lorcaserin for WeighT Loss in Schizophrenia

Phase 4

Terminated

Conditions: Schizophrenia
Overweight
Schizoaffective Disorder

Interventions: Drug: Placebo
Drug: Lorcaserin
Drug: Metformin

First Posted Date: 2016-06-10

Last Posted Date: 2021-03-03

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 71

Registration Number: NCT02796144

Locations: 🇺🇸
Augusta University, Augusta, Georgia, United States
🇺🇸
Carolina Behavioral Care, Hillsborough, North Carolina, United States
🇺🇸
New York State Psychiatric Institute (NYSPI), Columbia University, New York, New York, United States

and more 1 locations

A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ipragliflozin L-proline
Drug: Metformin
Drug: Placebo

First Posted Date: 2016-06-09

Last Posted Date: 2024-11-11

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 268

Registration Number: NCT02794792

Locations: 🇷🇺
Site RU70005, Moscow, Russian Federation
🇷🇺
Site RU70003, Moscow, Russian Federation
🇷🇺
Site RU70011, Moscow, Russian Federation

and more 11 locations

Safety of Metformin in Pregnancy

Completed

Conditions: Pregnancy
Polycystic Ovary Syndrom
Pregestational Diabetes

Interventions: Drug: any drug not known as a major teratogen or major fetotoxicant
Drug: metformin

First Posted Date: 2016-06-08

Last Posted Date: 2016-06-08

Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Target Recruit Count: 950

Registration Number: NCT02793505

Metformin and Core Temperature in Obese and Lean Males

Not Applicable

Completed

Conditions: Obesity

Interventions: Drug: Metformin

First Posted Date: 2016-05-26

Last Posted Date: 2016-10-10

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 18

Registration Number: NCT02783053

Locations: 🇳🇱
Academic Medical Center, Amsterdam, Netherlands

Metformin, Neo-adjuvant Temozolomide and Hypo- Accelerated Radiotherapy Followed by Adjuvant TMZ in Patients With GBM

Phase 2

Active, not recruiting

Conditions: Glioblastoma Multiforme

Interventions: Drug: Metformin

First Posted Date: 2016-05-23

Last Posted Date: 2023-10-24

Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Target Recruit Count: 50

Registration Number: NCT02780024

Locations: 🇨🇦
Montreal Neurological Institute - McGill University Health Centre, Montréal, Quebec, Canada

Combination of Metformine/Inulin Versus Metformin on Prostate Benign Hyperplasia in Metabolic Syndrome

Phase 3

Completed

Conditions: Metabolic Syndrome

Interventions: Dietary Supplement: Agave inulin
Drug: Metformin
Other: Metformin placebo
Other: Placebo of agave inulin

First Posted Date: 2016-05-20

Last Posted Date: 2016-05-20

Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Target Recruit Count: 40

Registration Number: NCT02778776

Locations: 🇲🇽
Universidad de Guadalajara, Guadalajara, Jalisco, México, Mexico

Combination of Metformin/Inulin vs Inulin on Adiponectin in Metabolic Syndrome

Phase 3

Completed

Conditions: Metabolic Syndrome

Interventions: Drug: Metformin
Other: Placebo of agave inulin
Dietary Supplement: Agave inulin
Other: Metformin placebo

First Posted Date: 2016-05-16

Last Posted Date: 2016-05-18

Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Target Recruit Count: 40

Registration Number: NCT02773927

Locations: 🇲🇽
Universidad de Guadalajara, Guadalajara, Jalisco, México, Mexico

The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Insulin
Drug: Metformin

First Posted Date: 2016-05-06

Last Posted Date: 2018-04-12

Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Target Recruit Count: 30

Registration Number: NCT02765347

Locations: 🇨🇳
The Third Affliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: peficitinib
Drug: Metformin

First Posted Date: 2016-05-03

Last Posted Date: 2024-10-16

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 24

Registration Number: NCT02760342

Locations: 🇯🇵
Site JP00001, Kagoshima, Japan

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