{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T12:41:23Z","timestamp":1774269683713,"version":"3.50.1"},"reference-count":10,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,1,7]],"date-time":"2020-01-07T00:00:00Z","timestamp":1578355200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Ultra\u2010rapid lispro (URLi) is a novel ultra\u2010rapid mealtime insulin. This study compared the pharmacokinetic and glucodynamic profiles, safety, and tolerability of URLi and lispro (Humalog<jats:sup>\u00ae<\/jats:sup>) in Japanese patients with type\u00a01 diabetes mellitus.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>This was a phase\u00a0I, single center, randomized, patient\u2010 and investigator\u2010blind, two\u2010period, cross\u2010over study. A total of 31 patients received a single subcutaneous 15\u2010U dose of URLi or lispro before undergoing a euglycemic clamp procedure. Primary pharmacokinetic endpoints were the time to early half\u2010maximal drug concentration and the area under the concentration versus time curve from 0 to 30\u00a0min postdose. The glucodynamic endpoints were the time to early half\u2010maximal glucose infusion rate before time to maximum glucose infusion rate, and the time to onset of insulin action.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>URLi showed accelerated insulin lispro absorption compared with lispro, as shown by a decrease of 56% (URLi: 10.2\u00a0min, lispro: 23.3\u00a0min; <jats:italic>P\u00a0<\/jats:italic>&lt;\u00a00.0001) in the early half\u2010maximal drug concentration, and a 2.4\u2010fold increase in the area under the concentration versus time curve from 0 to 30\u00a0min (<jats:italic>P\u00a0<\/jats:italic>&lt;\u00a00.0001). The duration of insulin lispro exposure was 88\u00a0min shorter after URLi administration compared with lispro. URLi reduced the early half\u2010maximal glucose infusion rate before time to maximum glucose infusion rate and the time to onset of insulin action significantly compared with lispro. The glucose infused within the first 30\u00a0min of the clamp was 2.16\u2010fold greater with URLi compared with lispro. There was no difference in total exposure or glucose infused between treatments. All treatment\u2010emergent adverse events were mild\/moderate in severity.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In Japanese type\u00a01 diabetes mellitus patients, URLi showed accelerated insulin lispro absorption, reduced late exposure, overall shorter duration and faster early insulin action compared with lispro.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.13195","type":"journal-article","created":{"date-parts":[[2019,12,9]],"date-time":"2019-12-09T14:16:05Z","timestamp":1575900965000},"page":"672-680","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Ultra\u2010Rapid Lispro results in accelerated insulin lispro absorption and faster early insulin action in comparison with Humalog<sup>\u00ae<\/sup> in Japanese patients with type\u00a01 diabetes"],"prefix":"10.1111","volume":"11","author":[{"given":"Masanari","family":"Shiramoto","sequence":"first","affiliation":[{"name":"SOUSEIKAI Hakata Clinic Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Risa","family":"Nasu","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0872-8576","authenticated-orcid":false,"given":"Tomonori","family":"Oura","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makoto","family":"Imori","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenji","family":"Ohwaki","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,1,7]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/193229681200600402"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9136(199607)13:7<625::AID-DIA134>3.0.CO;2-2"},{"key":"e_1_2_7_4_1","unstructured":"Eli Lilly and Company.Humalog (insulin lispro injection USP [rDNA origin]) for injection [Internet] 2013. Available from:https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2013\/020563s115lbl.pdfAccessed October 15 2019."},{"key":"e_1_2_7_5_1","unstructured":"United Therapeutics Corporation.REMODULIN\u00ae (treprostinil) Injection for subcutaneous or intravenous use [Internet] 2018. Available from:https:\/\/www.remodulin.com\/downloads\/remodulin-prescribinginformation.pdf. Accessed October 15 2019."},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2009.10.006"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/diaclin.20.1.11"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.15.4105"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/db19-1107-P"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12468"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12697"}],"container-title":["Journal of Diabetes Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjdi.13195","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdi.13195","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jdi.13195","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jdi.13195","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T02:15:13Z","timestamp":1693966513000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jdi.13195"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1,7]]},"references-count":10,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2020,5]]}},"alternative-id":["10.1111\/jdi.13195"],"URL":"https:\/\/doi.org\/10.1111\/jdi.13195","archive":["Portico"],"relation":{},"ISSN":["2040-1116","2040-1124"],"issn-type":[{"value":"2040-1116","type":"print"},{"value":"2040-1124","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1,7]]},"assertion":[{"value":"2019-07-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-01-07","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}