| Trial ID: | L3105 |
| Source ID: | NCT01280682
|
| Associated Drug: |
Rituximab
|
| Title: |
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01280682/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: rituximab
|
| Outcome Measures: |
Primary: Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide, Change of 3-hour mean area under the curve (AUC) of C-peptide at 6 months from baseline. AUC was calculated from C-peptide timing measurements during the 3-hour mixed meal tolerance test with the trapezoidal rule. The mean AUC for C-peptide is equal to the calculated AUC divided by the 3 h interval (i.e., AUC/180). All mean C-peptide AUC data were transformed as log (mean AUC) for analysis., 6 months after participants completed the injection | Secondary: Change of Fasting C-peptide, The change of fasting level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All fasting C-peptide data were transformed as log (fasting C-peptide) for analysis., 6 months after participants completed the injection|Change of Peak C-peptide, The change of peak level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All peak C-peptide data were transformed as log (peak C-peptide) for analysis., 6 months after participants completed the injection|HbA1c Levels, Glycated hemoglobin (HbA1c) levels (%), 6 months after participants completed the injection
|
| Sponsor/Collaborators: |
Sponsor: Yang Tao
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-07
|
| Completion Date: |
2018-12
|
| Results First Posted: |
2023-12-11
|
| Last Update Posted: |
2023-12-11
|
| Locations: |
First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu, 210029, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01280682
|
