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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
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.
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.
Age
4 - 40 years
Sex
ALL
Healthy Volunteers
No
Barbara Davis Center
Aurora, Colorado, United States
University of Chicago
Chicago, Illinois, United States
IU Health Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Mercy Hospital
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
MHealth Fairview Masonic Children's Hospital and Specialty Clinics
Minneapolis, Minnesota, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Start Date
March 14, 2023
Primary Completion Date
December 1, 2027
Completion Date
May 1, 2028
Last Updated
September 23, 2025
70
ESTIMATED participants
DFMO
DRUG
Placebo
DRUG
Lead Sponsor
Emily K. Sims
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455994