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. Author manuscript; available in PMC: 2015 Mar 31.
Published in final edited form as: Lancet. 2013 Jul 26;383(9911):69–82. doi: 10.1016/S0140-6736(13)60591-7

Table 2. Agents assessed as immunomodulatory therapy to reverse type 1 diabetes.

Study phase and year Main findings
Insulin APL (NBI-6042) Phase 2; 2009 No change in metabolic response (ie, C-peptide preservation)135
Anti-CD20 (rituximab) Phase 2; 2011 Preservation of C-peptide concentrations at 1 year, but no difference from placebo at2 years136
Anti-CD3 (teplizumab) Phase 3; 2011 Although phase 2 studies showed preservation of C-peptide concentrations, phase I trials (Protégé study)137 showed no change in metabolic respons and the study stopped early
CTLA4—immunoglobulin fusion protein (abatacept) Phase 2; 2011 T-cell co-stimulatory modulation slowed reduction in β-cell function over 2 years, although preservation of C-peptide was seen for 9·6 months138
Anti-CD3 (otelixizumab) Phase 3; 2011 Although phase 2 studies showed preservation of C-peptide concentrations, a phase 3 trial showed no change in metabolic response139
GAD65 protein (Diamyd) Phase 3; 2012 Phase 2 studies reported preserved C-peptide concentration, with no improvements in insulin needs. Two phase 3 trials did not meet endpoints140,141
HSP60 (DiaPep277) Phase 3; 2012 Phase 2 trials suggested increased C-peptide concentrations; a phase 3 trial noted C-peptide preservation at 1 year, but only in adults (age 16-45 years) with type 1 diabetes142