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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
~1090

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,674 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,359 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
~1 spots leftby Jun 2025
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