| Trial ID: | L3425 |
| Source ID: | NCT05594563
|
| Associated Drug: |
Dfmo
|
| Title: |
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
|
| Acronym: |
TADPOL
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: DFMO|DRUG: Placebo
|
| Outcome Measures: |
Primary: Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment, Primary endpoint defining clinical efficacy will be based on mixed-meal stimulated C-peptide area under the curve (AUC; in arbitrary units) in the treatment group compared to placebo after 6 months of DFMO treatment, 6 month|Number of participants with treatment-related adverse events as assessed by CTCAE v5, A summary of serious and non-serious adverse events (AEs) will be reported., through study completion, an average of one year | Secondary: Clinical efficacy of 1000 mg/m2/day of oral DFMO after 3 months of treatment, 9 months after treatment (or 3 months after treatment end), and 12 months after treatment (or 6 months after treatment end)., Secondary endpoints will be based on mixed meal stimulated C-peptide AUC (arbitrary units) at 3 months after treatment, 9 months after treatment, and 12 months after treatment., through study completion, an average of one year|Decrease in urinary polyamides after 6 months of DFMO treatment., Decrease in urinary putrescine (in umol/g Cr) from baseline after 6 months of DFMO treatment, measured using high performance liquid chromatography., up to 24 weeks after treatment|Biomarkers of β cell stress at 3, 6, 9, and 12 months after treatment., Fasting and stimulated proinsulin/c-peptide ratios (%) will be measured using immunoassays and reported at baseline, 3 months after treatment, 6 months after treatment, 9 months after treatment, and 12 months after treatment., through study completion, an average of one year
|
| Sponsor/Collaborators: |
Sponsor: Emily K. Sims | Collaborators: Juvenile Diabetes Research Foundation|Cancer Prevention Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-03-14
|
| Completion Date: |
2027-12
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-02
|
| Locations: |
Barbara Davis Center, Aurora, Colorado, 80045, United States|University of Chicago, Chicago, Illinois, 60637, United States|IU Health Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Children's Mercy Hospital, Kansas City, Kansas, 64108, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05594563
|
