Table 2.
Clinical trial history for the immunomodulatory treatment of type I diabetes and current state/outcomes.
| Treatment | Clinical phase | Last update | Notes |
|---|---|---|---|
| Anti-CD3 | Phase III, canceled | 2010 | Failed to change patient outcomes, and the phase III study was canceled early [64] |
| Anti-CD20 (rituximab) | Phase II, completed | 2009 | Beta cell mass preservation, but no change in C-peptide levels or insulin independence [65] |
| AS-ODN dendritic cells | Phase I, completed | 2011 | Treatment safety demonstrated |
| GAD65 protein (Diamyd) | Phase III, Ongoing | 2010 | Phase II displayed elevated anti-inflammatory cytokines and Treg cells. Insulin independence was not addressed [66, 67] |
| HSP60 (DiaPep277) | Phase III, ongoing | 2008 | Phase II trials display a trend of increased C-peptide levels, anti-inflammatory cytokines, and anti-inflammatory T-helper 2 cells [68] |
| Insulin APL (NBI-6042) | Phase II, failure | 2009 | Beta cell mass was unaffected [69, 70] |
| Insulin (intranasal) | Pilot | 2004 | Decreased T-cell responsiveness to insulin in patients expressing two to three diabetes-related autoantibodies [71, 72]. Additional clinical trials (phase I–III) are underway |
| Insulin (oral) | Phase I, failure | 2005 | Initial trials showed no prevention or delay of type 1 diabetes, but additional trials are underway [73, 74] |