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Phase 2Active, not recruitingNCT05594563

TADPOL: DFMO/polyamine pathway in recent-onset T1D

Randomized phase 2 study testing difluoromethylornithine (DFMO), a polyamine-pathway drug, to reduce beta-cell stress and preserve remaining insulin production in recent-onset T1D.

Primary endpoints

  • Clinical efficacy of oral DFMO after 6 months
  • Treatment-related adverse events

Results so far

No results posted. Enrolment is closed and the trial is active but no longer recruiting; the registry lists a target enrolment of 81 (still shown as estimated, not actual). Primary completion is expected December 2027, with study completion in May 2028.

The full picture

What it is and why it matters. TADPOL is testing whether an old, cheap, repurposed drug can help newly diagnosed people hold on to the insulin-making cells they still have. Most people diagnosed with type 1 diabetes still have some working beta cells for months or years afterwards, and keeping even a little of that insulin production makes blood sugar easier to control. The drug, DFMO (difluoromethylornithine), blocks an enzyme in the polyamine pathway; the theory is that this lowers the internal stress on beta cells that are struggling under immune attack, rather than suppressing the immune system itself.1

How it is designed. This is a randomised, placebo-controlled phase 2 trial in people aged 4-40 who were diagnosed within the past 100 days, still have measurable C-peptide (a marker of their own insulin production), and carry at least one T1D autoantibody. Participants are randomised 2:1 to take oral DFMO at 1000 mg/m2/day or a placebo for 6 months. What makes the design interesting is what comes next: a 6-month washout with no drug, to see whether any preserved insulin production survives after treatment stops — a durability question that many disease-modifying trials skip.2

Where it stands. Enrolment is closed and the trial is active but no longer recruiting, so it is now in follow-up. The registry lists a target enrolment of 81 participants across seven US sites — still shown as estimated, not actual, so the final headcount has not been confirmed. Primary completion is expected in December 2027, with study completion in May 2028. No results have been posted, and DFMO in T1D was not presented at ADA 2026 — so anyone reading about it today is reading about a hypothesis, not an outcome.3

References

  1. ClinicalTrials.gov. TADPOL: TArgeting Type 1 Diabetes Using POLyamines (NCT05594563). U.S. National Library of Medicine. https://clinicaltrials.gov/study/NCT05594563 ↩

  2. ClinicalTrials.gov. NCT05594563 record — eligibility, dosing and washout design. https://clinicaltrials.gov/study/NCT05594563 ↩

  3. ClinicalTrials.gov. NCT05594563 record — status active, not recruiting; target enrolment 81, listed as estimated rather than actual; no results posted (checked 2026-07-14). https://clinicaltrials.gov/study/NCT05594563 ↩