Two diabetes drugs together for high-risk mouth precancer (leukoplakia)
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
People with high-risk mouth precancer will take pioglitazone plus metformin twice daily for 12 weeks to look for changes in tissue and immune signs linked to cancer risk.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Minnesota NIH-funded |
| Lab location | 1 site (Minneapolis, United States) |
| Project ID | NIH-11188975 on NIH RePORTER |
What this research studies
You would take a combination of pioglitazone and metformin twice a day for 12 weeks at a participating clinic. Doctors will collect small biopsies of the visible precancer (like leukoplakia) and nearby normal mouth lining before and after treatment. Lab tests will measure drug effects on cancer-related molecular markers and on T cell subsets in the tissue. Researchers will also run RNA sequencing on the tissue samples to see how gene activity changes with the drugs. The work is run through a consortium of clinics in the Minneapolis–St. Paul area to enroll patients efficiently.
Who could benefit from this research
Good fit: Adults with high-risk oral precancer (for example, leukoplakia) who can travel to Minneapolis–St. Paul clinics, are medically able to take pioglitazone and metformin, and agree to biopsies and study visits are ideal candidates.
Not a fit: People without oral precancer, those with invasive oral cancer, or patients with medical contraindications to pioglitazone or metformin (such as certain heart or liver conditions) are unlikely to benefit from this trial.
Why it matters
Potential benefit: If the combination changes harmful molecular or immune signs, it could lead to a safe, widely available way to lower the chance that oral precancers progress to cancer.
How similar studies have performed: Previous NCI-sponsored trials showed each drug alone has acceptable safety and modest effects in oral precancer, but using the two together is a newer approach that has not yet been tested at large scale.
Where this research is happening
Minneapolis, United States
- University of Minnesota — Minneapolis, United States (Active)
Researchers
- Principal investigator: Ondrey, Frank G. — University of Minnesota
- Study coordinator: Ondrey, Frank G.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.