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 Longevity Study (MILES).

Phase 4

Completed

Conditions: Aging

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2015-05-04

Last Posted Date: 2021-05-21

Lead Sponsor: Albert Einstein College of Medicine

Target Recruit Count: 16

Registration Number: NCT02432287

Locations: 🇺🇸
Einstein College of Medicine of Yeshiva University, Bronx, New York, United States

Survivorship Promotion In Reducing IGF-1 Trial

Phase 2

Completed

Conditions: Melanoma of Skin
Endometrial Cancer
Liver Cancer
Pancreatic Cancer
Rectal Cancer
Kidney Cancer
Other Solid Malignant Tumors
Breast Cancer
Prostate Cancer
Lung Cancer

Interventions: Behavioral: Self-control weight loss
Behavioral: Coach Directed Behavioral Weight Loss
Drug: Metformin

First Posted Date: 2015-05-01

Last Posted Date: 2024-08-28

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 121

Registration Number: NCT02431676

Locations: 🇺🇸
Johns Hopkins ProHealth, Baltimore, Maryland, United States

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Phase 4

Completed

Conditions: Type II Diabetes

Interventions: Drug: Placebo
Drug: Farxiga
Drug: Metformin
Drug: Insulin

First Posted Date: 2015-04-29

Last Posted Date: 2017-06-14

Lead Sponsor: AstraZeneca

Target Recruit Count: 226

Registration Number: NCT02429258

Locations: 🇺🇸
Research Site, Renton, Washington, United States

Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy

Phase 2

Terminated

Conditions: Recurrent Prostate Carcinoma
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer

Interventions: Drug: Aspirin
Other: Laboratory Biomarker Analysis
Other: Placebo
Drug: Metformin Hydrochloride

First Posted Date: 2015-04-20

Last Posted Date: 2023-02-08

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 27

Registration Number: NCT02420652

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Late Metabolic Effects of Metformin Therapy in Gestational Diabetes

Completed

Conditions: Gestational Diabetes

Interventions: Drug: Insulin
Drug: Metformin

First Posted Date: 2015-04-15

Last Posted Date: 2020-12-11

Lead Sponsor: Turku University Hospital

Target Recruit Count: 173

Registration Number: NCT02417090

Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: placebo
Drug: SAR425899
Drug: metformin

First Posted Date: 2015-04-08

Last Posted Date: 2018-06-15

Lead Sponsor: Sanofi

Target Recruit Count: 76

Registration Number: NCT02411825

Locations: 🇩🇪
Investigational Site Number 276001, Berlin, Germany

Insulin Resistance and Mild Cognitive Impairment (IRMCI) Study

Phase 4

Terminated

Conditions: Mild Cognitive Impairment
Insulin Resistance
Diabetes Mellitus, Type 2

Interventions: Behavioral: Standard LIfestyle Recommendation
Drug: Metformin
Behavioral: Intensive Lifestyle Intervention

First Posted Date: 2015-04-06

Last Posted Date: 2023-01-11

Lead Sponsor: SingHealth Polyclinics

Target Recruit Count: 105

Registration Number: NCT02409238

Locations: 🇸🇬
SingHealth Polyclinics - Marine Parade Polyclinic, Singapore, Singapore

Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Saxagliptin
Drug: Insulin
Drug: Vitamin D3
Drug: Metformin

First Posted Date: 2015-04-03

Last Posted Date: 2021-04-20

Lead Sponsor: Second Xiangya Hospital of Central South University

Target Recruit Count: 300

Registration Number: NCT02407899

Locations: 🇨🇳
Gansu Provincial Hospital, Lanzhou, Gansu, China
🇨🇳
Guangdong General Hospital, Guangzhou, Guangdong, China
🇨🇳
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, Changsha, Hunan, China

and more 36 locations