MedPath

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
C4H11N5
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
-

A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: SAR425899
Drug: Liraglutide
Drug: Metformin
First Posted Date
2016-11-25
Last Posted Date
2022-03-24
Lead Sponsor
Sanofi
Target Recruit Count
296
Registration Number
NCT02973321
Locations
🇷🇺

Investigational Site Number 6430003, Saratov, Russian Federation

🇷🇺

Investigational Site Number 6430001, St-Petersburg, Russian Federation

🇷🇺

Investigational Site Number 6430005, Voronezh, Russian Federation

and more 56 locations

Metformin Therapy in HCV Infection

Phase 4
Completed
Conditions
Chronic Hepatitis C Infection
Interventions
First Posted Date
2016-11-23
Last Posted Date
2016-11-23
Lead Sponsor
Nottingham University Hospitals NHS Trust
Target Recruit Count
16
Registration Number
NCT02972723
Locations
🇬🇧

Secondary care Hepatitis clinic at Nottingham University Hospital, Nottingham, United Kingdom

Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Not Applicable
Recruiting
Conditions
Diabetes Mellitus, Type 2
Impaired Fasting Glucose (IFG)
Impaired Glucose Tolerance (IGT)
Interventions
First Posted Date
2016-11-21
Last Posted Date
2024-08-07
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
700
Registration Number
NCT02969798
Locations
🇺🇸

The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2016-11-10
Last Posted Date
2023-08-01
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
24
Registration Number
NCT02960659
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

Phase 1
Completed
Conditions
Type2 Diabetes Mellitus
Interventions
First Posted Date
2016-11-04
Last Posted Date
2021-07-22
Lead Sponsor
Theracos
Target Recruit Count
54
Registration Number
NCT02956044
Locations
🇺🇸

Clinical Research Site, Evansville, Indiana, United States

A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: INSULIN GLARGINE (U300)
Drug: metformin
Drug: sulfonylurea
Drug: meglitinides
Drug: thiazolidinediones
Drug: alpha-glucosidase inhibitors
Drug: GLP1 Receptor Agonist
Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors
Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors
First Posted Date
2016-11-03
Last Posted Date
2019-01-14
Lead Sponsor
Sanofi
Target Recruit Count
112
Registration Number
NCT02954692

The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation

Not Applicable
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Metformin
Other: Placebo
First Posted Date
2016-11-01
Last Posted Date
2017-09-27
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
15
Registration Number
NCT02951260
Locations
🇩🇰

Center for aktiv sundhed, Copenhagen, Copenhagen N, Denmark

Phase I/II Study OF Metformin in Combination With Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma

Phase 1
Completed
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
First Posted Date
2016-10-31
Last Posted Date
2023-06-29
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
26
Registration Number
NCT02949700
Locations
🇺🇸

Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, United States

🇺🇸

Harris Health System - Smith Clinic, Houston, Texas, United States

🇺🇸

Baylor College of Medicine, Houston, Texas, United States

Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia

Phase 1
Completed
Conditions
Anemia
Night Sweats
Splenomegaly
Recurrent Plasma Cell Myeloma
Thrombocytopenia
Lymphadenopathy
Lymphocytosis
Refractory Chronic Lymphocytic Leukemia
Refractory Plasma Cell Myeloma
Weight Loss
Interventions
Other: Laboratory Biomarker Analysis
Drug: Metformin Hydrochloride
Other: Pharmacological Study
Drug: Ritonavir
Other: Quality-of-Life
Other: Questionnaire
First Posted Date
2016-10-28
Last Posted Date
2021-02-12
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
3
Registration Number
NCT02948283
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
Drug: Metformin
Other: OPC
First Posted Date
2016-10-27
Last Posted Date
2025-01-03
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
41
Registration Number
NCT02946996
Locations
🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

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