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Anti-Diabetic Agents
Pioglitazone-Metformin for Oral Leukoplakia
Phase 2
Waitlist Available
Led By Frank Ondrey
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 12 weeks of intervention or at early termination.
Awards & highlights
Study Summary
This trial tests a combination of two drugs to reduce risk of mouth cancer in people with leukoplakia. It will look at changes from before and after the 12-week treatment.
Who is the study for?
This trial is for adults with biopsy-proven high-risk oral leukoplakia, specifically in areas like the floor of the mouth or tongue. Participants must have lesions measurable in two dimensions and be able to swallow tablets whole. They should not have active invasive cancer within the last 18 months, no diabetes treated with insulin or antidiabetic agents, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests a combination of pioglitazone (15mg) and metformin (500mg) taken twice daily for 12 weeks on patients with oral leukoplakia. It aims to see if this treatment reduces the grade of leukoplakia and decreases cell proliferation in lesions compared to before treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with pioglitazone or metformin such as digestive issues, risk of low blood sugar levels, headaches, muscle pain, respiratory tract infections, sinus problems, sore throat or inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 12 weeks of intervention or at early termination.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 12 weeks of intervention or at early termination.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Ki-67
Clinical change in leukoplakia
histologic change in leukoplakia
Trial Design
1Treatment groups
Experimental Treatment
Group I: oral leukoplakia patientsExperimental Treatment1 Intervention
36 total high risk oral leukoplakia patients.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,939 Total Patients Enrolled
Frank OndreyPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
21 Total Patients Enrolled
1 Trials studying Oral Leukoplakia
21 Patients Enrolled for Oral Leukoplakia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My mouth sore has abnormal cell growth.I have no medical reasons preventing me from undergoing a skin biopsy.I have had bladder cancer in the past.I have a biopsy showing abnormal cell growth in specific areas of my mouth or throat.I am allergic to medications similar to ACTOplus Met, pioglitazone, or metformin.I agree to use effective birth control or abstain from sex during the study.I have measurable white patches in my mouth.I am 18 years old or older.I have diabetes (Type I or II) and am treating it with medication, or my Type II diabetes is diet/exercise controlled.My organs are functioning well, as tested within the last 2 weeks.I can swallow pills whole and follow a 12-week medication schedule.I have abnormal cell growth in my mouth or throat.I haven't had any cancer except for non-dangerous skin or cervical cancer in the last 18 months.My cancer lesion is in my mouth or throat and can be biopsied.My lesion is white, red, or both white and red.
Research Study Groups:
This trial has the following groups:- Group 1: oral leukoplakia patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this study?
"The research hosted on clinicaltrials.gov shows that, while originally posted on August 31st 2023 and last updated in February 4th 2023, this medical trial is no longer actively recruiting for candidates. However, there are 10 alternative trials currently enrolling patients at the moment."
Answered by AI
Is the FDA sanctioning oral leukoplakia treatments?
"Our team at Power has assigned oral leukoplakia a safety score of 2 due to its Phase 2 clinical trial status. This indicates that there is some evidence supporting the medication's safety, but not yet any data confirming its efficacy."
Answered by AI
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