drugset / Trial / NCT02411253

Low-dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes

NCT02411253

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells, leading to an absolute deficiency in insulin. In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and likewise prevent autoimmune diseases. Tregs are insufficient in T1D. The investigators previously showed that administration of low doses of IL-2 induces selective expansion and activation of Tregs in mice and humans. The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could block the ongoing autoimmune destruction of insulin producing cells in patients with recently diagnosed T1D.

Timeline

Start
2015-06
Primary completion
2020-11
Completion
2022-11

Drugs

EvaluationDrugModalityDoseRoute
Subject rhIL-2 Protein / enzyme biologic 0.5 unknown Subcutaneous
Subject rhIL-2 Protein / enzyme biologic 1e+06 iu Subcutaneous