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Active Not Recruiting
NCT05594563
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
Conditions: Type 1 Diabetes
Sex: All
Ages: 4 Years – 40 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 81
Sponsor: Emily K. Sims
Location: Barbara Davis Center Aurora Colorado
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.
Eligibility Criteria
Inclusion Criteria:
1. Males and females 4- ≥40 years of age with a clinical diagnosis of T1D
2. T1D clinical diagnosis with insulin start date no more than 100 days prior to the time of randomization
3. Random non-fasting C-peptide level of \>0.2 pmol/mL (equivalent to \>0.6ng/ml) at screening.
4. Positive for any one of the following diabetes-related autoantibodies (IAA, GAA, IA-2, or ZnT8)
5. Treatment naïve of any immunomodulatory agent
6. Normal hearing at screening, defined as acceptable results of pure-tone audiometry (\
Source: ClinicalTrials.gov (NCT05594563). StuddyBuddy aggregates publicly available trial information.