ClinicalTrials.gov posted results on 2 September 2026 for a Phase 2 trial associated with canagliflozin in the supplied drug record. The study itself evaluated extended-release metformin hydrochloride versus placebo for preventing oral cancer in people with oral leukoplakia or erythroplakia, enrolling 34 participants.
The posted measurements included histologic and clinical response counts, as well as changes in C-peptide and glucose. The registry listed the study as active, not recruiting.
Background
The trial examined metformin, a drug in the biguanide class, in patients with oral leukoplakia, described in the record as white patches, or erythroplakia, described as red patches. The stated purpose was to test whether metformin could help prevent oral cancer or stop changes in the mouth. The registry listed extended-release metformin hydrochloride and placebo administration as the interventions.
Trial design
This was a Phase 2 study identified as NCT05237960. It enrolled 34 participants with oral leukoplakia or erythroplakia and compared extended-release metformin with placebo. The record identified histologic response, clinical response, C-peptide change, and glucose change among the reported outcomes. No primary outcome entries were supplied in the data.
Key results
For histologic response, the listed participant counts were 9 participants and 6 participants in the extended-release metformin arm, compared with 7 participants and 7 participants in the placebo arm. The record did not identify the context for the repeated entries.
Clinical response counts were 7 participants and 8 participants with extended-release metformin, versus 6 participants and 8 participants with placebo. The supplied analyses included Fisher exact p-values of 0.715 and 1.
Mean C-peptide change was -32 pmol/L with a standard deviation of 200 pmol/L for metformin and 75 pmol/L with a standard deviation of 151 pmol/L for placebo. Mean glucose change was -9 mg/dL with a standard deviation of 29 mg/dL for metformin and 7 mg/dL with a standard deviation of 11 mg/dL for placebo. The listed two-sided t-test p-values were 0.103, 0.052, and 0.076.
What this means
The posted record provides response counts and metabolic measurements from a small metformin-versus-placebo trial in oral leukoplakia or erythroplakia. The results show different arm-level values across the reported outcomes, but the supplied data do not identify which analysis corresponds to each p-value.
No adverse-event summary was provided. The record does not establish a new indication for canagliflozin or metformin, and it does not document a regulatory approval.
Source
Source: ClinicalTrials.gov, registry record for “Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia,” NCT05237960, with results posted on 2 September 2026. The record is available at clinicaltrials.gov/study/NCT05237960.