Table 1.

Antigen-specific therapies described in this review article. This article almost solely focusses on larger controlled trials, some small proof-of-concept trials are included that are of particular interest. The trials are listed according to their order of appearance in this article.

Trial designation+ref.	Design	Outcome
(prepro)Insulin
Diabetes Prevention Trial (DPT-1) [47] (oral insulin)	Secondary prevention	No delay, post hoc subgroup effect identified
NCT00419562 (oral insulin)	Secondary prevention	Currently recruiting, results expected February 2014
IMDIAB [48]	Recent-onset	No preservation of beta cell function
Diabète Insuline Orale group [49]	Recent-onset	No preservation of beta cell function
MacLaren et al. [50]	Recent-onset	No preservation of beta cell function
Type 1 diabetes prediction and prevention (DIPP) [54] (nasal insulin)	Secondary prevention	No delay
Intranasal insulin trial (INIT-1) [52]	Safety trial in prevention	Safe, no delay or acceleration, INIT-II trial ongoing (NCT00336674)
Fourlanos et al. [55]	Recent-onset	No preservation of beta cell function
Primary Oral/intranasal INsulin Trial (Pre-point) [56] (oral/nasal insulin)	Primary prevention	Recruiting
Diabetes Prevention Trial (DPT-1) [58] (parenteral insulin)	Secondary prevention	No delay
Belgian Diabetes Registry [99] (parenteral insulin)	Secondary prevention	No delay
Proinsulin peptide vaccination [36]	Safety trial in longstanding disease	Safe, immunological tolerance signs observed
Insulin B chain vaccination [37]	Safety trial in recent-onset	Safe, immunological tolerance signs observed
GAD65
GAD-alum [75,76]	Dose-escalation study in LADA	Safe, beta cell function preservation with 20 μg dose
GAD-alum [77]	Recent-onset	Beta cell function preservation
GAD-alum (TrialNet) [82]	Recent-onset	No preservation of beta cell function
GAD-alum (Europe) [83]	Recent-onset	No preservation of beta cell function
GAD-alum (U.S., DIAPREVENT, NCT00751842)	Recent-onset	Suspended
Diabetes prevention — Immune Tolerance	Secondary prevention	Ongoing, fully enrolled
(DIAPREV-IT; NCT01122446)
HSP60 (p277)
DiaPep277 pilot trial [89]	Recent-onset	Evidence of beta cell preservation
Huurman et al. [91]	Recent-onset	Trend for beta cell preservation
Lazar et al. [92]	Recent-onset	No trend for beta cell preservation
Schloot et al. [93]	Recent-onset	Trend for beta cell preservation
Buzzetti et al. [94]	Recent-onset	Trend for beta cell preservation
DiaPep277 phase III trial (www.andromedabio.com/news.php)	Recent-onset	Evidence of beta cell preservation, confirmatory trial ongoing