{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T23:46:37Z","timestamp":1788565597796,"version":"build-2803163510"},"reference-count":0,"publisher":"Frontiers Media SA","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Pharm Pharm Sci"],"abstract":"<jats:p>Purpose. To determine the risk of clinical trial failure for drugs developed for type-2 diabetes. \u00a0Methods. Drugs were investigated by reviewing phase I to phase III studies that were conducted between 1998 and February 2013. The clinical trial success rates were calculated and compared to the industry standard. The drugs were classified into GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors and \u201cOther\u201d. The exclusion criteria for drugs in this study: Drugs that were started in phase I studies prior to January 1998 for this indication and drugs whose primary indications were not for the control of blood glucose levels.\u00a0 Results. Data was extracted from clinicaltrials.gov; there were a total of 131 drug candidates that fit our specified criteria, of which 8 received FDA approval. The cumulative success rate for molecules developed for type-2 diabetes is 10%. Small molecules were more successful than biologics. A strong disparity was observed in phase III, with studies that utilised treatment na\u00efve patients having a 40% success rate, compared to an 83% success rate in patients who have had previous anti-hyperglycemic exposure. \u00a0Conclusions. 1 in 10 drugs that enter clinical testing in this disease will be approved. The DPP-4 inhibitor class of drugs had the highest success rate of all drug classes with a 63% cumulative success rate; while treatment na\u00efve patients carried the greatest clinical trial risk.\u00a0\u00a0Keywords: Clinical trials, Type-2 diabetes, Drug development, Clinical trial risk.\u00a0This article is open to POST-PUBLICATION REVIEW. Registered readers (see \u201cFor Readers\u201d) may comment by clicking on ABSTRACT on the issue\u2019s contents page.<\/jats:p>","DOI":"10.18433\/j3hg73","type":"journal-article","created":{"date-parts":[[2016,3,18]],"date-time":"2016-03-18T23:08:33Z","timestamp":1458342513000},"page":"393","source":"Crossref","is-referenced-by-count":4,"title":["Clinical Trial Risk in Type-2 Diabetes: Importance of Patient History"],"prefix":"10.3389","volume":"17","author":[{"given":"Emmanuel O.","family":"Aiyere","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay","family":"Silverberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Safina","family":"Ali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jayson L.","family":"Parker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2014,8,25]]},"container-title":["Journal of Pharmacy &amp; Pharmaceutical Sciences"],"original-title":[],"deposited":{"date-parts":[[2023,1,13]],"date-time":"2023-01-13T13:34:33Z","timestamp":1673616873000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.library.ualberta.ca\/jpps\/index.php\/JPPS\/article\/view\/22987"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,8,25]]},"references-count":0,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2014,7,16]]}},"URL":"https:\/\/doi.org\/10.18433\/j3hg73","relation":{},"ISSN":["1482-1826","1482-1826"],"issn-type":[{"value":"1482-1826","type":"electronic"},{"value":"1482-1826","type":"print"}],"subject":[],"published":{"date-parts":[[2014,8,25]]}}}