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
-

Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

Phase 3
Completed
Conditions
Dyslipidemia
Type II Diabetes
Interventions
First Posted Date
2015-10-26
Last Posted Date
2018-10-03
Lead Sponsor
Yuhan Corporation
Target Recruit Count
249
Registration Number
NCT02586129
Locations
🇰🇷

Seoul National Universitiy Bundang Hospital, Seongnam-Si, Gyeonggi-Do, Korea, Republic of

Impact of OCT1 on Metformin Tolerance

Phase 4
Completed
Conditions
Tolerance
Interventions
First Posted Date
2015-10-26
Last Posted Date
2018-06-13
Lead Sponsor
NHS Tayside
Target Recruit Count
61
Registration Number
NCT02586636
Locations
🇬🇧

Ninewells Hospital, Dundee, Angus, United Kingdom

Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion

Phase 2
Active, not recruiting
Conditions
Erythroplakia
Oral Cavity Carcinoma
Oral Leukoplakia
Hyperplasia
Interventions
Other: Laboratory Biomarker Analysis
Drug: Metformin Hydrochloride
First Posted Date
2015-10-20
Last Posted Date
2024-06-25
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
26
Registration Number
NCT02581137
Locations
🇺🇸

UC San Diego Medical Center - Hillcrest, San Diego, California, United States

🇨🇦

BC Cancer Research Centre, Vancouver, British Columbia, Canada

🇺🇸

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

and more 1 locations

Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-10-16
Last Posted Date
2016-11-30
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
25
Registration Number
NCT02577315
Locations
🇷🇺

1276.27.001 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation

DDI (Effect of Metformin and Furosemide on Rosuvastatin PK)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-10-14
Last Posted Date
2023-11-07
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
18
Registration Number
NCT02574845
Locations
🇩🇪

Humanpharmakologisches Zentrum Biberach, Biberach, Germany

Continuation of Metformin to Improve And Keep Peri-operative Glycemic Control

Phase 4
Withdrawn
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2015-10-08
Last Posted Date
2021-10-08
Lead Sponsor
McMaster University
Registration Number
NCT02571608

Metformin for Preventing Frailty in High-risk Older Adults

Phase 2
Completed
Conditions
Frailty
Interventions
Drug: Metformin
Drug: Placebo
First Posted Date
2015-10-07
Last Posted Date
2024-03-04
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
145
Registration Number
NCT02570672
Locations
🇺🇸

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

The Effect of Metformin on Different Hormones in PCOS Patients

Phase 4
Completed
Conditions
Polycystic Ovarian Syndrome
Interventions
First Posted Date
2015-10-06
Last Posted Date
2017-03-21
Lead Sponsor
Ahmed Maged
Target Recruit Count
48
Registration Number
NCT02568488

A Drug-drug Interaction Study Between Daclatasvir and Metformin

Phase 1
Completed
Conditions
Hepatitis C
Diabetes Mellitus
Insulin Resistance
Interventions
First Posted Date
2015-10-01
Last Posted Date
2020-12-07
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
20
Registration Number
NCT02565862
Locations
🇳🇱

CRCN, Radboud University Medical Center, Nijmegen, Netherlands

Metformin Improves Clinical Pregnancy Rate in Polycystic Ovarian Syndrome Patients

Phase 2
Completed
Conditions
Reproductive Endocrinology
Polycystic Ovarian Syndrome
Interventions
Drug: CC
Drug: Placebo tablets
Drug: Metformin
First Posted Date
2015-09-29
Last Posted Date
2020-08-12
Lead Sponsor
Assiut University
Target Recruit Count
66
Registration Number
NCT02562664
© Copyright 2025. All Rights Reserved by MedPath