NCT05594563

TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Emily K. Sims · Academic / Other
• Sex: All
• Age: 4 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be a multicenter, double-blind, placebo-controlled, 2:1 random assigned, phase II clinical trial for individuals with recent onset type 1 diabetes. The investigators are conducting a double masked placebo-controlled intention to treat study enrolling persons with new onset T1D with documented continued residual C-peptide production. Within 45 days of screening and a run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 6-month double-masked treatment period with either DFMO or placebo. After a 6-month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned either 1000mg/m2/day oral DFMO or placebo treatment at a 2:1 ratio.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	DFMO	DFMO orally twice a day
DRUG	Placebo	Placebo orally twice a day

Timeline

• Start date: 2023-03-14
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2022-10-26
• Last updated: 2025-09-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study