drugset / Trial / NCT02411253
Low-dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhIL-2 | Protein / enzyme biologic | 0.5 unknown | Subcutaneous |
| Subject | rhIL-2 | Protein / enzyme biologic | 1e+06 iu | Subcutaneous |