{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T11:46:17Z","timestamp":1788349577936,"version":"build-2803163510"},"reference-count":17,"publisher":"American Diabetes Association","issue":"5","license":[{"start":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T00:00:00Z","timestamp":1679356800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/journals\/pages\/license"}],"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":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,5,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>Basal insulin Fc (BIF) (insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain, is designed for once-weekly basal insulin administration. This phase 2 study assessed the safety and efficacy of BIF versus degludec in insulin-naive patients with type 2 diabetes (T2D) previously treated with oral antihyperglycemic medications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>During this randomized, parallel, open-label study, 278 insulin-naive patients with T2D were randomly assigned (1:1) to receive BIF once weekly or degludec once daily over the 26-week treatment period. Both groups were titrated to fasting glucose of 80\u2013100 mg\/dL (4.4 to &amp;lt;5.6 mmol\/L). The primary end point was HbA1c change from baseline to week 26 (noninferiority margin 0.4%). Secondary end points included fasting blood glucose (FBG), six-point glucose profiles, and rate of hypoglycemia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>After 26 weeks of treatment, BIF demonstrated a noninferior HbA1c change from baseline versus degludec, with a treatment difference of 0.06% (90% CI \u22120.11, 0.24; P = 0.56). Both BIF and degludec treatment led to significant reductions in FBG from baseline. At week 26, the between-treatment difference for BIF versus degludec was 4.7 mg\/dL (90% CI 0.1, 9.3; P = 0.09). The rate of level 2 hypoglycemia was low and not significantly different between treatment groups (BIF 0.22 events\/patient\/year, degludec 0.15 events\/patient\/year; P = 0.64); there was no severe hypoglycemia. The occurrence of treatment-emergent adverse events was also similar between BIF and degludec.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Once-weekly BIF achieved excellent glycemic control similar to degludec, with no concerning hypoglycemia or other safety findings.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc22-2396","type":"journal-article","created":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T18:54:28Z","timestamp":1679424868000},"page":"1060-1067","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":47,"title":["Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial"],"prefix":"10.2337","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9746-7744","authenticated-orcid":false,"given":"Juliana M.","family":"Bue-Valleskey","sequence":"first","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christof M.","family":"Kazda","sequence":"additional","affiliation":[{"name":"2Lilly France, Neuilly sur Seine, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenchen","family":"Ma","sequence":"additional","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny","family":"Chien","sequence":"additional","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qianyi","family":"Zhang","sequence":"additional","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Chigutsa","sequence":"additional","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Landschulz","sequence":"additional","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Haupt","sequence":"additional","affiliation":[{"name":"1Eli Lilly and Company, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan P.","family":"Frias","sequence":"additional","affiliation":[{"name":"3Velocity Clinical Research, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2023,3,21]]},"reference":[{"key":"2023042619074968900_B1","doi-asserted-by":"crossref","first-page":"S83","DOI":"10.2337\/dc22-S006","article-title":"6. 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