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

SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy

Phase 2

Terminated

Conditions: Prostate Cancer

Interventions: Drug: Metformin
Radiation: Salvage Radiotherapy SRT

First Posted Date: 2016-10-26

Last Posted Date: 2022-04-14

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 112

Registration Number: NCT02945813

Locations: 🇫🇷
Centre de lutte contre le cancer Léon Bérard, Lyon, France
🇫🇷
Centre Hospitalier Régional Universitaire (CHRU) Jean Minjoz, Besançon, France
🇨🇭
Hôpitaux Universitaires Genève HUG, Geneva, Switzerland

and more 24 locations

Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss

Phase 4

Completed

Conditions: Polycystic Ovary Syndrome
Body Weight

Interventions: Drug: sitagliptin and metformin
Drug: Metformin

First Posted Date: 2016-10-21

Last Posted Date: 2016-10-21

Lead Sponsor: University Medical Centre Ljubljana

Target Recruit Count: 24

Registration Number: NCT02941445

Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Lixisenatide (AVE0010)
Drug: Sulfonylurea
Drug: metformin
Drug: basal insulin

First Posted Date: 2016-10-21

Last Posted Date: 2022-04-25

Lead Sponsor: Sanofi

Target Recruit Count: 184

Registration Number: NCT02941367

Locations: 🇮🇳
Investigational Site Number 356005, Ahmedabad, India
🇮🇳
Investigational Site Number 356002, Bangalore, India
🇮🇳
Investigational Site Number 356008, Bangalore, India

and more 13 locations

Metformin as an Upstream Therapy in Atrial Fibrillation

Phase 2

Terminated

Conditions: Atrial Fibrillation

Interventions: Drug: Metformin

First Posted Date: 2016-10-13

Last Posted Date: 2024-01-25

Lead Sponsor: The Guthrie Clinic

Target Recruit Count: 6

Registration Number: NCT02931253

Locations: 🇺🇸
The Guthrie Clinic, Sayre, Pennsylvania, United States

Effect of Insulin Sensitization on IGF-1 Response to Growth Hormone in SGA Children

Not Applicable

Conditions: Small for Gestational Age

Interventions: Drug: Growth Hormone
Drug: Metformin
Drug: Placebo

First Posted Date: 2016-10-13

Last Posted Date: 2016-10-14

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 24

Registration Number: NCT02931591

Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

Phase 3

Terminated

Conditions: Diabetes
Pregnancy

Interventions: Drug: Metformin
Drug: Placebo

First Posted Date: 2016-10-13

Last Posted Date: 2023-06-26

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 831

Registration Number: NCT02932475

Locations: 🇺🇸
University of Mississippi, Jackson, Mississippi, United States
🇺🇸
University of California - San Diego, San Diego, California, United States
🇺🇸
Ohio State University, Columbus, Ohio, United States

and more 7 locations

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Sotagliflozin (SAR439954)
Drug: Metformin

First Posted Date: 2016-10-06

Last Posted Date: 2021-05-11

Lead Sponsor: Lexicon Pharmaceuticals

Target Recruit Count: 518

Registration Number: NCT02926950

Locations: 🇺🇸
Investigational Site Number 8402041, Los Angeles, California, United States
🇺🇸
Investigational Site Number 8402006, Hialeah, Florida, United States
🇺🇸
Investigational Site Number 8402044, Hialeah, Florida, United States

and more 90 locations

Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Metformin
Drug: saxagliptin

First Posted Date: 2016-09-30

Last Posted Date: 2016-10-03

Lead Sponsor: Shanghai Zhongshan Hospital

Target Recruit Count: 31

Registration Number: NCT02920801

Locations: 🇨🇳
Fang Li, Shanghai, Shanghai, China

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Dapagliflozin
Drug: Metformin
Drug: Glipizide 5 MG

First Posted Date: 2016-09-22

Last Posted Date: 2023-11-30

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Target Recruit Count: 72

Registration Number: NCT02911792

Locations: 🇺🇸
University Health Systems Texas Diabetic Institute, San Antonio, Texas, United States
🇺🇸
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin
Other: Placebo

First Posted Date: 2016-09-22

Last Posted Date: 2017-11-14

Lead Sponsor: Assiut University

Target Recruit Count: 102

Registration Number: NCT02910817

Locations: 🇪🇬
Assiut University, Assiut, Egypt

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