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 in Co-morbid Diabetes or Prediabetes and Serious Mental Illness

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2
Schizophrenia

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2014-06-19

Last Posted Date: 2018-07-30

Lead Sponsor: Centre for Addiction and Mental Health

Target Recruit Count: 35

Registration Number: NCT02167620

Locations: 🇨🇦
Center for Addiction and Mental Health, Toronto, Ontario, Canada

Stereotactic Radiosurgery and Metformin in Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer

Early Phase 1

Completed

Conditions: Duct Cell Adenocarcinoma of the Pancreas
Stage I-III Pancreatic Cancer
Acinar Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer

Interventions: Drug: metformin hydrochloride
Radiation: stereotactic radiosurgery

First Posted Date: 2014-06-03

Last Posted Date: 2020-06-26

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 8

Registration Number: NCT02153450

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Dulaglutide
Drug: Insulin Glargine
Drug: Metformin

First Posted Date: 2014-06-02

Last Posted Date: 2019-09-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 300

Registration Number: NCT02152371

Locations: 🇺🇸
Valley Endocrine, Fresno, Fresno, California, United States
🇺🇸
Northwest Endo Diabetes Research, LLC, Arlington Heights, Illinois, United States
🇺🇸
Mills-Peninsula Diabetes Research Insitute, San Mateo, California, United States

and more 17 locations

Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Low Metformin
Drug: Mid Metformin
Drug: High Metformin
Drug: Metformin

First Posted Date: 2014-05-30

Last Posted Date: 2018-02-27

Lead Sponsor: NuSirt Biopharma

Target Recruit Count: 96

Registration Number: NCT02151461

Locations: 🇺🇸
Meridian Research, Savannah, Georgia, United States
🇺🇸
Meharry Medical College, Nashville, Tennessee, United States
🇺🇸
Palm Beach Research, Palm Beach, Florida, United States

and more 6 locations

Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy

Phase 1

Conditions: Brain Neoplasms

Interventions: Radiation: Partial brain re-irradiation.
Drug: Metformin
Behavioral: low carbohydrate diet

First Posted Date: 2014-05-29

Last Posted Date: 2017-10-27

Lead Sponsor: Sheba Medical Center

Target Recruit Count: 18

Registration Number: NCT02149459

Locations: 🇮🇱
Sheba Medical Center, Ramat Gan, Israel

Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

Phase 1

Withdrawn

Conditions: Melanoma

Interventions: Drug: Dabrafenib
Drug: Trametinib
Drug: Metformin

First Posted Date: 2014-05-20

Last Posted Date: 2023-11-18

Lead Sponsor: University of Louisville

Registration Number: NCT02143050

Locations: 🇺🇸
James Graham Brown Cancer Center-Universityof Louisville, Louisville, Kentucky, United States
🇺🇸
James Graham Brown Cancer Center, Louisville, Kentucky, United States

Effects of Metformin and Fish Oil on Treatment With Clozapine

Phase 4

Terminated

Conditions: Schizophrenia
Schizo-affective Disorder

Interventions: Drug: Metformin
Drug: Fish Oil

First Posted Date: 2014-05-16

Last Posted Date: 2023-10-26

Lead Sponsor: Duke University

Target Recruit Count: 34

Registration Number: NCT02140788

Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

Phase 4

Conditions: Type 2 Diabetes

Interventions: Drug: Exenatide
Drug: Metformin

First Posted Date: 2014-05-02

Last Posted Date: 2014-05-02

Lead Sponsor: xiaolong zhao

Target Recruit Count: 100

Registration Number: NCT02129985

Locations: 🇨🇳
Xiaolong Zhao, Jingan, Shanghai, China

Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in the Elderly

Phase 1

Completed

Conditions: Healthy Elderly

Interventions: Drug: Metformin

First Posted Date: 2014-04-29

Last Posted Date: 2014-04-29

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 12

Registration Number: NCT02125305

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

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2

Active, not recruiting

Conditions: Brenner Tumor
Malignant Pleural Effusion
Ovarian Endometrioid Adenocarcinoma
Recurrent Fallopian Tube Cancer
Recurrent Primary Peritoneal Cavity Cancer
Ovarian Clear Cell Cystadenocarcinoma
Stage IIIC Fallopian Tube Cancer
Malignant Ascites
Ovarian Mixed Epithelial Carcinoma
Recurrent Ovarian Epithelial Cancer

Interventions: Drug: metformin hydrochloride
Drug: placebo
Drug: Chemotherapy

First Posted Date: 2014-04-24

Last Posted Date: 2024-07-31

Lead Sponsor: University of Chicago

Target Recruit Count: 110

Registration Number: NCT02122185

Locations: 🇺🇸
Mitchell Cancer Institute - University of South Alabama, Mobile, Alabama, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 7 locations

Drug Development Updates

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