Current State of Type 1 Diabetes Immunotherapy: Incremental Advances, Huge Leaps, or More of the Same?

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]