| Trial ID: | L4421 |
| Source ID: | NCT00662519
|
| Associated Drug: |
Neulasta (Pegylated)
|
| Title: |
Neulasta in Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Neulasta (Pegylated)|DRUG: Placebo|DIETARY_SUPPLEMENT: Mixed Meal Tolerance Test (MMTT)|OTHER: Blood test|OTHER: DNA Test
|
| Outcome Measures: |
Primary: Area Under the Curve C-peptide Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks., The target population distribution of change in the Area Under the Curve in residual beta cell function (C-peptide levels) is the same for treatment and placebo., Changed Time 0, 12 weeks, 24 weeks, 48 weeks and 96 weeks.|Number of participants with adverse events, 96 Weeks | Secondary: Hemoglobin A1c (HbA1c) levels have the same target distribution for treatment and placebo, 96 weeks|Increase T regulatory cells (Treg) from the bone marrow, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: Juvenile Diabetes Research Foundation|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2014-03
|
| Results First Posted: |
|
| Last Update Posted: |
2015-04-09
|
| Locations: |
University of Florida, Gainesville, Florida, 32610, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00662519
|
