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Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

NCT05727761•University of Minnesota

Summary

This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in \> 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Biopsy proven hyperplasia in high risk anatomic areas (floor of mouth, mobile tongue, oropharynx). Hyperplasia or dysplasia of any grade in any erythroplakia lesion. Mild, moderate or severe dysplasia within the lesion at any site of the oral cavity or oropharynx.
•Must have objective evidence of oral leukoplakia that is measurable in 2 dimensions per RECIST. The lesion(s) may be clinically characterized by leukoplakia, erythroplakia, erythro/leukoplakia. Lesions may be located in the oral cavity or oropharynx. However, the index lesion must be located in an anatomic site accessible by punch biopsy and be a minimum of 4mm x 8 mm to permit a 4mm punch biopsy.
•Age 18 years or older at the time of consent.
•Evidence of adequate organ function within 14 days prior to Day 1
•Able to comply with treatment (i.e. able to swallow a tablet whole, not crushed) and complete a 12 week course of twice daily medication as required by this study in the opinion of the treating investigator.
•Body mass index (BMI) is ≥ 18.5.
•Sexually active persons of child-bearing potential agrees to use adequate contraception (a hormonal method that has been in continual use for a minimum of 3 months prior to the study screening visit, a barrier method, or abstinence) for the duration of study participation.
•Provides voluntary written consent prior to the performance of any research related activity.

Exclusion Criteria

•Pregnant or breastfeeding or planning to become pregnant.
•A concurrent diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent. Participants whose Type II diabetes is controlled with diet and/or exercise alone are eligible provided they meet all other eligibility criteria.
•Participant is taking another investigational agent (not approved by the FDA for any indication).
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ACTOplus Met, pioglitazone or metformin.
•Any contraindication to biopsy - this study requires a 4 mm punch biopsy of a lesion and of nearby normal tissue prior to treatment and at the end of the 12 week treatment period.
•History of bladder cancer, including in situ bladder cancer.
•History of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) active within 18 months prior to the baseline study visit. (Participants who have a history of cancer that was curatively treated without evidence of recurrence in the 18 months prior to the baseline study visit are considered eligible).

Locations (2)

University of Minnesota

Minneapolis, Minnesota, United States

HealthPartners

Saint Paul, Minnesota, United States

Key Dates

Start Date

January 1, 2025

Primary Completion Date

July 28, 2026

Completion Date

July 28, 2026

Last Updated

December 24, 2025

Enrollment

ESTIMATED participants

Conditions

Oral Leukoplakia

Interventions

pioglitazone-metformin

DRUG

Contacts

Beverly Wuertz

CONTACT

612-625-3090 knier003@umn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

Inclusion Criteria

Exclusion Criteria

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