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NCT05594563 · ClinicalTrials.gov registry record · Phase 2
TArgeting Type 1 Diabetes Using POLyamines (TADPOL)
A Phase 2 study of Type 1 Diabetes, sponsored by Emily K. Sims.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 7
- Study locations
NCT05594563: Recruiting Phase 2 study of Type 1 Diabetes, sponsored by Emily K. Sims.
NCT05594563 is a Phase 2 study of Type 1 Diabetes that is actively recruiting participants, run by Emily K. Sims. The registered enrollment target is 70 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05594563, a Phase 2 study of Type 1 Diabetes, is actively recruiting participants, sponsored by Emily K. Sims.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DFMO
Study Locations (7)
Colorado
- Barbara Davis Center - Aurora
Illinois
- University of Chicago - Chicago
Indiana
- IU Health Riley Hospital for Children - Indianapolis
Kansas
- Children's Mercy Hospital - Kansas City
Michigan
- University of Michigan - Ann Arbor
Minnesota
- MHealth Fairview Masonic Children's Hospital and Specialty Clinics - Minneapolis
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-03-14 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT05594563 shows while recruiting
NCT05594563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05594563 lists 7 locations in 7 states (Colorado, Illinois, Indiana).
Frequently Asked Questions
What is clinical trial NCT05594563 about?
NCT05594563 is a clinical study titled "TArgeting Type 1 Diabetes Using POLyamines (TADPOL)". 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...
What is the current status of trial NCT05594563?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-03-14. Estimated completion is 2028-05.
What conditions does trial NCT05594563 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT05594563?
The interventions under investigation include: Placebo (DRUG), DFMO (DRUG).
Who is sponsoring clinical trial NCT05594563?
This trial is sponsored by Emily K. Sims, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05594563 being conducted?
This trial has 7 study locations across Colorado, Illinois, Indiana, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05594563's enrollment target sits among peer trials
70 68th of 198 higher than 129 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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