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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EAdministration of DiaPep277\u00ae is safe and represents a promising therapeutic strategy in patients with recent-onset type 1 diabetes (T1DM). Results of two large Phase 3 trials will determine if this therapy might change the current approach to treating newly diagnosed T1DM patients [Tuccinardi D et al. \u003Cem\u003EExpert Opin Biol Ther\u003C\/em\u003E 2011].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EAdministration of DiaPep277\u00ae is safe and represents a promising therapeutic strategy in patients with recent-onset type 1 diabetes (T1DM). Results of two large Phase 3 trials will determine if this therapy might change the current approach to treating newly diagnosed T1DM patients [Tuccinardi D et al. \u003Cem\u003EExpert Opin Biol Ther\u003C\/em\u003E 2011].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EItamar Raz, MD, Hadassah Medical Center, Jerusalem, Israel, reported outcomes from 1 of these trials\u2014a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients [DIA-AID 1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00615264\u0026amp;atom=%2Fspmdc%2F12%2F16%2F14.atom\u0022\u003ENCT00615264\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDIA-AID 1 was a 2-year double-blind study conducted in 42 medical centers in 11 countries in Europe, South Africa, and Israel. It included 457 patients aged 16 to 45 years with newly diagnosed T1D (\u0026lt;3 months) and residual \u03b2-cell function fasting C-peptide \u22650.22 nmol\/L.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe peptide DiaPep227 is an immunodominant epitope of heat shock protein 60 that is found in insulin secretory granules of \u03b2 cells. It is thought to be an autoantigen and induces T regulatory cells via toll-like receptors [Gupta S. \u003Cem\u003EMed Clin N Am\u003C\/em\u003E 2012].\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EPatients were randomized 1:1 to receive a total of 9 injections of either 1 mg DiaPep277 or placebo administered quarterly at a medical center. The primary outcome was the change in stimulated C-peptide area under the curve (AUC) from baseline to Month 24 as measured by a 20-minute glucagon-stimulated test. Secondary outcomes included the change in stimulated C-peptide AUC from baseline to Month 24 as measured by the mixed-meal tolerance test (MMTT), the proportion of patients who maintained HbA1C levels \u22647% at the end of the study, and the change in fasting C-peptide from baseline to Month 24.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe primary efficacy endpoint in the modified intention-to-treat population (mITT) showed a trend that became significant (p=0.037) at 24 months, with a 23.4% decline in progression in the DiaPep277 group versus placebo. The difference was even more pronounced in the per-protocol (PP) population, with a relative treatment effect of 29.2% (p=0.011).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EAmong the secondary endpoints, there was no significant difference between the placebo and treatment groups in change in stimulated C-peptide AUC from baseline to Month 24 as measured by the MMTT. Although there was a trend toward a treatment effect in the change from baseline in fasting C-peptide, the difference between the treatment and placebo groups was not significant.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EA significantly greater number of treated patients in the mITT population maintained HbA1C levels \u22647% at the end of the study versus those who received placebo (p=0.03), with an even greater difference between the 2 groups in the PP population (p=0.0082). The number of patients with at least 1 treatment emergent adverse advent (TEAE) was 173 (76.9%) in the DiaPep277 group and 164 (71%) in the placebo group. The number of patients with at least 1 life-threatening TEAE was the same for both groups (2; 0.9%). The most common TEAEs were nasopharyngitis, influenza, upper respiratory tract infection, gastroenteritis, headache, pyrexia, and back pain.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EOutcomes from a continuous glucose monitoring substudy conducted on 78 patients at 17 sites showed a significantly lower number of hyperglycemic excursions per patient (defined by glucose levels \u0026gt;140 mg\/dL) in the DiaPep277-treated group compared with those who received the placebo (11.5 vs 14.4; p=0.032). In the treated group, the duration of hypoglycemia was shorter and the magnitude of the events showed a strong trend of less severity.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/16\/14.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn8q2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}