OncoMatch/Clinical Trials/NCT05727761
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Is NCT05727761 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies pioglitazone-metformin for oral leukoplakia.
Treatment: pioglitazone-metformin — 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.
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For patients with oral leukoplakia.
This summary was generated by AI from the trial's official eligibility criteria and may contain errors. Always confirm with the study team before contacting a site.
US trial sites
- University of Minnesota · Minneapolis, Minnesota
- HealthPartners · Saint Paul, Minnesota
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