drugset / Trial / NCT02586831
Diabetes Islet Preservation Immune Treatment
RandomizedParallel-groupTriple-blindTreatment
Summary
To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2024-06-01
- Completion
- 2024-06-01
Publications
- Background Skyler JS. Prevention and reversal of type 1 diabetes--past challenges and future opportunities. Diabetes Care. 2015 Jun;38(6):997-1007. doi: 10.2337/dc15-0349.
- Background Skyler JS, Ricordi C. Stopping type 1 diabetes: attempts to prevent or cure type 1 diabetes in man. Diabetes. 2011 Jan;60(1):1-8. doi: 10.2337/db10-1114. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2.5 mg/kg | — |
| Subject | Adalimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Exenatide | Peptide | 2 mg | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 1e+06 iu | Subcutaneous |