drugset / Trial / NCT02586831

Diabetes Islet Preservation Immune Treatment

NCT02586831

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

Drugs

EvaluationDrugModalityDoseRoute
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