| Trial ID: | L2443 |
| Source ID: | NCT01106157
|
| Associated Drug: |
Anti-Thymocyte Globin (Atg)
|
| Title: |
Reversing Type 1 Diabetes After it is Established
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01106157/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Anti-Thymocyte Globin (ATG)|DRUG: Placebo|DRUG: Pegylated GCSF
|
| Outcome Measures: |
Primary: Change in Metabolic Function Baseline to 12 Months., Area Under Curve (AUC) C-peptide production. Subjects underwent a 2 hour mixed meal tolerance test (MMTT) using a 6ml/kg load of boost to stimulate insulin production. Samples were collected at baseline, 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, and 120 minutes. AUC was then calculated. Subjects repeated the MMTT at baseline, 3, 6, 9, and 12 months following ATG/GCSF or placebo. The primary outcome for the study was the change over 12 months in AUC C-peptide (1 year - baseline) for those who received ATG/GCSF versus the change in AUC C-peptide (1 year - baseline) for those who received placebo, Baseline and 12 months | Secondary: Percent Change in Regulatory T Cells (Treg) Baseline to 12 Months, Change in regulatory T cells (Treg) baseline to 12 months, Change in Baseline to 12 months|A1c, Change in A1c baseline to 12 months, Change in baseline to 12 months|Change in Insulin Requirements, Baseline to 12 Months, Change in Insulin Requirements, baseline to 12 months, Change from baseline to 12 months|Change in Glutamic Acid Decarboxylase Antibodies (GADA) From Baseline to 12 Months, Change in Glutamic Acid Decarboxylase Antibodies (GADA) over 12 months, Change from baseline to 12 months|Change in Insulin Autoantibodies (IAA) From Baseline to 12 Months, Change in Insulin Autoantibodies (IAA) over 12 months, Change from baseline to 12 months|Change in Insulinoma Associated 2 Autoantibodies (IA-2A) From Baseline to 12 Months, Change in Insulinoma Associated 2 Autoantibodies (IA-2A), Change from baseline to 12 months|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) From Baseline to 12 Months, Change in Zinc Transporter 8 Autoantibodies (ZnT8A) over 12 months, Change from baseline to 12 months|Percentage of Neutrophils, Change in Neutrophil Count over 12 months, Change from baseline to 12 months|Change in White Blood Count (WBC) From Baseline to 12 Months, Change in WBC over 12 months, Change from baseline to 12 months
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust|Genzyme, a Sanofi Company
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-04
|
| Completion Date: |
2019-07-16
|
| Results First Posted: |
2016-01-20
|
| Last Update Posted: |
2019-08-05
|
| Locations: |
University of California, San Francisco, San Francisco, California, 94143-0748, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045-6511, United States|University of Florida, Gainesville, Florida, 32610-0296, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01106157
|
