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Biguanide

Metformin for Oral Premalignant Lesions

Phase 1
Waitlist Available
Research Sponsored by Thomas Jefferson University
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 up to 3 years
Awards & highlights

Study Summary

This trial tests whether the diabetes drug metformin can prevent or slow the development of oral cancer from precancerous lesions.

Who is the study for?
This trial is for adults aged 18-85 with certain types of oral precancerous lesions, who are in good health and can consent to the study. Diabetics on metformin will have their dose adjusted; others may start it after consulting an endocrinologist. People with invasive cancer, immune suppression, or allergies to metformin cannot join.Check my eligibility
What is being tested?
The trial is testing if metformin, a diabetes drug that might prevent cancer, can stop oral precancerous spots from becoming cancer. Participants will take metformin daily and undergo regular biopsies to monitor changes in their lesions.See study design
What are the potential side effects?
Metformin's side effects include digestive issues like nausea and diarrhea, potential vitamin B12 deficiency over time, and rarely lactic acidosis—a serious metabolic complication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transformation-free-survival, in lesion types erythroplakia and verrucous hyperplasia
Secondary outcome measures
Change in lesion status
Other outcome measures
Transformation-free-survival, in lesion types homogenous leukoplakia and non-homogenous leukoplakia

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (metformin)Experimental Treatment2 Interventions
Patients receive metformin PO QD on days 1-3 and then PO BID for up to 12 months in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Biopsy
2014
Completed Phase 4
~850

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,508 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,207 Total Patients Enrolled
12 Trials studying Leukoplakia
1,055 Patients Enrolled for Leukoplakia

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05536037 — Phase 1
Leukoplakia Research Study Groups: Prevention (metformin)
Leukoplakia Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT05536037 — Phase 1
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536037 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Metformin achieved regulatory sanction from the Food and Drug Administration?

"The safety of Metformin is estimated to be a 1 due to this being an early-phase trial, with only limited data available on its efficacy and safety."

Answered by AI

Are there opportunities to volunteer for this trial currently?

"Based on the information available from clinicaltrials.gov, this medical trial is currently recruiting patients. This research was initially published on May 4th 2022 and has been recently revised as of September 7th 2022."

Answered by AI

What is the size of the cohort participating in this trial?

"Correct. Clinicaltrials.gov data affirms that this clinical study is actively seeking participants, with 116 individuals needing to be enrolled at a single medical centre since the trial was first posted on May 4th 2022 and last updated on September 7th 2022."

Answered by AI

To whom is this medical exploration available?

"This trial is searching for 116 individuals aged between 18 and 85, that are suffering from leukoplakia. Prospective participants need to possess the following criteria: Clinical manifestion of lesion, Non-uniform leukoplakia, Erythroplakia, Histological appearance, Slight dysplasia, Age range 18-85 years old Homogeneous leukoplakial Proliferative verrucous leukoplakial No dysplasia or Moderate dysplasia."

Answered by AI

Does this clinical research encompass elderly individuals?

"This research program is open to participants above the age of consent and below 85 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions
2022. "Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05536037.
~40 spots leftby Apr 2025
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