| Trial ID: | L2645 |
| Source ID: | NCT02384889
|
| Associated Drug: |
Difluoromethylornithine
|
| Title: |
DFMO in Children With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Difluoromethylornithine|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants with Dose Limiting Toxicities, Low platelet counts, low white blood cell counts, low hemoglobin, severe abdominal pain/diarrhea, hearing loss, 6 month | Other: Changes in Serum Markers of Beta Cell Stress, Observed Changes in pro-insulin and c-peptide measured from blood, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Indiana University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-04
|
| Completion Date: |
2020-01-06
|
| Results First Posted: |
|
| Last Update Posted: |
2021-09-05
|
| Locations: |
Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Women and Children's Hospital of Buffalo, Buffalo, New York, 14222, United States|Children's Hospital of Wisconsin, Wauwatosa, Wisconsin, 53226, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02384889
|
