CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 81 target
Drug / intervention
DFMO +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05594563
NCT05594563Phase 2ActiveHigh Momentum

TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes

Emily K. Sims·interventional·Posted Oct 26, 2022·Updated Jun 22, 2026

In Brief

A Phase 2 clinical trial evaluating DFMO and Placebo for Type 1 Diabetes. Active but no longer recruiting, targeting 81 participants across 7 sites.

Signals

Enrolling ahead of pace

Detailed Summary

The goal of this clinical trial is to test a drug known as DFMO in people with Type 1 Diabetes (T1D). The main question\[s\] it aims to answer are: * Does it reduce stress on the cells that make insulin? * Does it preserve what is left of the body's insulin production? Participants will take either DFMO or a placebo (looks like DFMO but has no active ingredients) two times a day for about 6 months. Participants will have 6 in person visits and 1 phone visit over a period of 12 months. Visits will include blood draws urine collection and other tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States

Timeline

Phase 2Active
202320242025202620272028
First PostedOct 26, 2022
Enrollment StartMar 14, 2023
Primary CompletionDec 1, 2027
Study CompletionMay 1, 2028
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 3.7 years agoPrimary completion in 1.4 years

Interventions

DFMOdrug

DFMO orally twice a day

Placebodrug

Placebo orally twice a day