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Anti-Thymocyte Globin · 1 trial · 1 indication
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., ...
Anti-Thymocyte Globin is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus. It is being developed by Sanofi (SNY) and has completed a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.
Anti-Thymocyte Globin is a small molecule therapeutic. The specific molecular target of Anti-Thymocyte Globin has not been disclosed in the available clinical trial information. It is being investigated for its potential role in treating Type 1 Diabetes Mellitus.
Anti-Thymocyte Globin is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical research to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.
Anti-Thymocyte Globin is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is still investigational. It has not received FDA approval and is not yet available for commercial use.
Anti-Thymocyte Globin has one completed clinical trial registered under NCT01106157, titled "Reversing Type 1 Diabetes After it is Established." This Phase 1 study enrolled 25 participants with Type 1 Diabetes Mellitus in the United States and was placebo-controlled.
Anti-Thymocyte Globin is the name used in the clinical trial for this investigational drug. No alternative names have been reported in the available information. It is a distinct therapeutic agent being studied for Type 1 Diabetes Mellitus.