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TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

NCT05594563 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DFMO

DFMO orally twice a day

DRUG

Placebo

Placebo orally twice a day

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Cancer Prevention Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Emily K. Sims

    lead OTHER

Principal Investigators

  • Emily K Sims, MD,MS · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2027-12-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594563 on ClinicalTrials.gov