Clinical trialNCT05237960Active, not recruitingPhase 2Interventional

Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia

SponsorUniversity of ArizonaEnrollment34ErythroplakiaOral Leukoplakia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase IIb trial tests whether metformin works in preventing oral cancer in patients with oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the blood. It decreases the amount of glucose patients absorb from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood. This trial may help researchers determine if metformin can stop changes in the mouth that are related to pre-cancer growths in the mouth.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Scott M Lippman
University of California, San Diego Moores Cancer Center
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Dalhousie University
Halifax, Nova Scotia, Canada

United States

University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Uc San Diego Medical Center - Hillcrest
San Diego, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Louisiana State University
Lafayette, Louisiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota/masonic Cancer Center
Minneapolis, Minnesota, United States
Nyu College of Dentistry
New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Extended Release Metformin HydrochloridePlacebo Administration

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 Jan 2023
Primary completion: 7 Nov 2025
Completion: 31 Dec 2026
Last update posted: 28 Sept 2026
Registered enrollment: 34
Registry id: NCT05237960

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.