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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 (active, not recruiting). The live registry (last update 21 August 2026) lists actual enrolment 74, not the earlier estimated 81, and estimated primary/study completion June 2027.

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 live registry lists actual enrolment 74 (the earlier 81 figure was an estimate) and estimated primary completion June 2027. No results have been posted — 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 — ACTIVE_NOT_RECRUITING; actual n=74; estimated primary completion June 2027; no results posted (live-checked 27 August 2026). https://clinicaltrials.gov/study/NCT05594563 ↩