This study is testing a drug called DFMO in people with recently diagnosed Type 1 Diabetes (T1D). The goal is to see if DFMO can help reduce stress on cells that make insulin and preserve the body's natural insulin production. You could be eligible if you are between 4 and 40 years old, have a T1D diagnosis within the last 100 days, and show some remaining insulin production (C-peptide level >0.2 pmol/mL) and specific diabetes-related antibodies. Participants will take either DFMO or a placebo (an inactive substance that looks like DFMO) twice a day for about 6 months. The study will measure how well DFMO works after 6 months and track any side effects throughout the study, which lasts about one year.

Study design

This is a Phase II, multicenter, double-blind, placebo-controlled study with 81 participants. Participants will be randomly assigned to receive either DFMO or placebo in a 2:1 ratio.

What's involved

You would have 6 in-person visits and 1 phone visit over 12 months. Visits will include blood draws, urine collection, and other tests.

Compensation

Not stated in the trial record.

Follow-up

The durability of the effect will be assessed after a 6-month wash-out period, following the 6-month treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.