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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 is a Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 41 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02384889
The ClinicalTrials.gov registry entry for NCT02384889 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02384889 reports 0 study locations.
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.
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