Oral Leukoplakia study: Pioglitazone-metformin
Official title Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
ClinicalTrials.gov ID: NCT05727761
What this study is testing
What is pioglitazone-metformin?
an investigational oral tablet being studied as a potential treatment for oral leukoplakia is designed to activate PPAR‑γ (pioglitazone) and AMPK (metformin) pathways that may reduce cell proliferation in the mouth lining
Also referred to as pioglitazone (Actos), metformin (Glucophage).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if taking the drugs for 12 weeks changes the size or appearance of oral leukoplakia and reduces cell growth markers.
- Who it's for
- Adults who have oral leukoplakia (white patches in the mouth).
- What's involved
- Participants will take pioglitone 15 mg and metformin 500 mg twice daily for 12 weeks and have clinic visits for exams and tissue samples.
- Time commitment
- The trial lasts about three months with regular visits to check the mouth lesions and collect samples.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Biopsy proven hyperplasia in high risk anatomic areas (floor of mouth, mobile tongue, oropharynx).
- Must have objective evidence of oral leukoplakia that is measurable in 2 dimensions per RECIST.
- 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...
You likely can't join if
- 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.
- 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...
- History of bladder cancer, including in situ bladder cancer.
See the full eligibility 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.
- 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.
- 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...
- Provides voluntary written consent prior to the performance of any research related activity.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
- Saint Paul, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States; Saint Paul, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.