Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Status:
Not yet recruiting
Trial end date:
2026-08-31
Target enrollment:
Participant gender:
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.