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NCT02384889 · ClinicalTrials.gov registry record · Phase 1
DFMO in Children With Type 1 Diabetes
A Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT02384889: Completed Phase 1 study, sponsored by Indiana University.
NCT02384889 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02384889, a Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1 clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study enrolling patients with new onset type 1 diabetes with documented continued residual C-peptide production. After a 4 week screening and run-in period during which eligibility will be determined and glycemic control optimized, subjects will have a 3-month double-masked treatment period with either DFMO or placebo. After a 3 month wash-out period the durability of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3 to placebo in each cohort) to 1 of 4 sequential dose cohorts.
Primary Outcome
Low platelet counts, low white blood cell counts, low hemoglobin, severe abdominal pain/diarrhea, hearing loss
Interventions
- DRUG Placebo
- DRUG Difluoromethylornithine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2015-04 |
| Est. Completion | 2020-01-06 |
| Phase | Phase 1 |
What the finished NCT02384889 record still lists
NCT02384889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02384889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02384889 about?
NCT02384889 is a clinical study titled "DFMO in Children With Type 1 Diabetes". This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1 clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study enrolling patients with new onset type 1 diabetes with documented continued residual C-peptide production. After a 4 w...
What is the current status of trial NCT02384889?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2015-04. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT02384889?
The interventions under investigation include: Placebo (DRUG), Difluoromethylornithine (DRUG).
Who is sponsoring clinical trial NCT02384889?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02384889's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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