Actively Recruiting
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Led by University of Minnesota · Updated on 2025-12-24
36
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy proven hyperplasia in high risk anatomic areas (floor of mouth, mobile tongue, oropharynx) or hyperplasia/dysplasia of any grade in erythroplakia lesions
- Measurable oral leukoplakia lesion(s) of at least 4mm x 8mm accessible for punch biopsy
- Age 18 years or older at consent
- Adequate organ function within 14 days before treatment start
- Able to swallow tablets whole and complete 12 weeks of twice daily medication
- Body mass index (BMI) at least 18.5
- Sexually active persons of child-bearing potential agree to use adequate contraception during the study
- Provide voluntary written consent before any research activities
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Diagnosed with Type I or Type II diabetes treated with insulin or antidiabetic medication (except diet/exercise control)
- Taking any other investigational agent not FDA approved
- History of allergic reaction to pioglitazone, metformin, or similar compounds
- Any contraindication to biopsy
- History of bladder cancer, including in situ
- History of invasive cancer (except non-melanoma skin or cervical cancer in situ) active within 18 months before baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
2
HealthPartners
Saint Paul, Minnesota, United States, 55130
Actively Recruiting
Research Team
B
Beverly Wuertz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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