Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01106157 | Reversing Type 1 Diabetes After it is Established | PHASE1 | COMPLETED | 25 | — | — | Apr 1, 2010 | Jul 16, 2019 | Aug 5, 2019 | 3 | United States |
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
| Arm | Type | Description |
|---|---|---|
| Anti-Thymocyte Globin plus pegylated GCSF | EXPERIMENTAL | Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks. |
| Placebo | PLACEBO_COMPARATOR | Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner |
| Name | Type | Description |
|---|---|---|
| Anti-Thymocyte Globin (ATG) | DRUG | Anti-Thymocyte Globin (ATG) will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2. |
| Placebo | DRUG | Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes |
| Pegylated GCSF | DRUG | 6 doses of pegylated GCSF (6mg/dose) will be given subcutaneously every 2 weeks beginning after the ATG infusion. |
Inclusion Criteria: * Must be \> 12 years \< 45 * Must have a diagnosis of T1D of greater than 4 months duration, with an upper limit of 2 years, Now only recruiting for those diagnosed greater than 1 year but less than 2 years. * Must have at least one diabetes-related autoantibody present (e.g., ...