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

A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ranolazine
Drug: Placebo to match ranolazine
Drug: Metformin
Drug: Placebo to match metformin
Behavioral: Diet
Behavioral: Exercise

First Posted Date: 2012-03-15

Last Posted Date: 2014-09-23

Lead Sponsor: Gilead Sciences

Target Recruit Count: 442

Registration Number: NCT01555164

Locations: 🇺🇸
New Phase Research & Development, Knoxville, Tennessee, United States
🇺🇸
National Research Institute, Los Angeles, California, United States
🇺🇸
Baptist Diabetes Associates, Miami, Florida, United States

and more 139 locations

Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: Ranolazine

First Posted Date: 2012-03-07

Last Posted Date: 2012-07-11

Lead Sponsor: Gilead Sciences

Target Recruit Count: 24

Registration Number: NCT01546597

Locations: 🇺🇸
Cetero Research, San Antonio, Texas, United States

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: Ranolazine

First Posted Date: 2012-03-07

Last Posted Date: 2012-07-11

Lead Sponsor: Gilead Sciences

Target Recruit Count: 25

Registration Number: NCT01546558

Locations: 🇺🇸
SeaView Research Inc., Miami, Florida, United States

Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin

Not Applicable

Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions: Drug: Metformin
Drug: Atorvastatin
Drug: Low dose metformin

First Posted Date: 2012-03-06

Last Posted Date: 2014-05-28

Lead Sponsor: Prof Antonino Belfiore

Target Recruit Count: 150

Registration Number: NCT01544751

Locations: 🇮🇹
Endocrinology Unit, Catanzaro, Italy

Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Sitagliptin
Drug: Placebo
Drug: Metformin

First Posted Date: 2012-03-06

Last Posted Date: 2018-08-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 337

Registration Number: NCT01545388

Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Metformin
Drug: vildagliptin

First Posted Date: 2012-03-01

Last Posted Date: 2016-11-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 3091

Registration Number: NCT01541956

Locations: 🇨🇳
Novartis Investigative Site, Beijing, China

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: liraglutide
Drug: placebo
Drug: metformin

First Posted Date: 2012-02-29

Last Posted Date: 2021-07-02

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 135

Registration Number: NCT01541215

Locations: 🇬🇧
Novo Nordisk Investigational Site, Southampton, United Kingdom

Temsirolimus in Combination with Metformin in Patients with Advanced Cancers

Phase 1

Active, not recruiting

Conditions: Advanced Cancers

Interventions: Drug: Temsirolimus
Drug: Metformin

First Posted Date: 2012-02-09

Last Posted Date: 2024-11-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 87

Registration Number: NCT01529593

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo of vildagliptin
Drug: vildagliptin
Drug: Metformin

First Posted Date: 2012-02-07

Last Posted Date: 2020-09-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 2004

Registration Number: NCT01528254

Locations: 🇹🇷
Novartis Investigative Site, Kahramanmaras, Turkey

Metformin in Children With Relapsed or Refractory Solid Tumors

Phase 1

Completed

Conditions: Primary Brain Tumors
Solid Tumors

Interventions: Drug: Vincristine
Drug: Irinotecan
Drug: Temozolomide
Drug: Metformin

First Posted Date: 2012-02-07

Last Posted Date: 2023-01-13

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 26

Registration Number: NCT01528046

Locations: 🇺🇸
Primary Children's Medical Center/Utah, Salt Lake City, Utah, United States
🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

and more 11 locations

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