{"id":11305,"date":"2010-10-21T03:54:16","date_gmt":"2010-10-21T07:54:16","guid":{"rendered":"http:\/\/asweetlife.org\/?p=11305"},"modified":"2015-12-30T02:44:21","modified_gmt":"2015-12-30T07:44:21","slug":"eli-lilly-suspends-trials-for-new-type-1-diabetes-drug","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=11305","title":{"rendered":"Eli Lilly Suspends Trials for New Type 1 Diabetes Drug"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/10\/EliLillyLogo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"size-medium wp-image-11307 alignleft lazyload\" style=\"margin: 4px;\" title=\"EliLillyLogo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/10\/EliLillyLogo-300x172.jpg\" alt=\"\" width=\"180\" height=\"103\" \/><\/a>Eli Lilly and Co. and MacroGenics Inc. announced that the Protege Data Monitoring Committee (DMC), has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab.<br \/> The DMC, composed of independent experts in the fields of diabetes and biostatistics, concluded that the primary efficacy endpoint of the study was not met.<\/p>\n<p style=\"text-align: justify;\">Following careful evaluation of the DMC&#8217;s recommendations for Protege, based on the lack of efficacy, the companies have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in <a href=\"https:\/\/asweetlife.org\/diabetes\/type-1-diabetes\/\">type 1 diabetes<\/a>: the <a href=\"https:\/\/asweetlife.org\/emily\/blogs\/type-1-blogs\/hopeful-and-heated-reflections-on-the-protege-encore-trial-in-seattle-washington\/7752\/\">Protege Encore Trial<\/a>, a second Phase 3 trial of the same design as Protege, and the SUBCUE trial, a Phase 1b trial that is exploring the subcutaneous administration in patients with type 1 diabetes.<br \/> Teplizumab is an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.<\/p>\n<p>For full press release <a href=\"http:\/\/newsroom.lilly.com\/releasedetail.cfm?ReleaseID=521014\" target=\"_blank\">click here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Eli Lilly and Co. and MacroGenics Inc. announced that the Protege Data Monitoring Committee (DMC), has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab.<br \/>\nThe DMC, composed of independent experts in the fields of diabetes and biostatistics, concluded that the primary efficacy endpoint of the study was not met&#8230;<\/p>\n","protected":false},"author":131,"featured_media":11307,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1445],"tags":[964],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Eli Lilly Suspends Trials for New Type 1 Diabetes Drug<\/title>\n<meta name=\"description\" content=\"Eli Lilly and MacroGenics announced that analysis the Protege Phase 3 clinical trial of teplizumab data has found that 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