{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T02:15:18Z","timestamp":1793499318471,"version":"4.5.0"},"reference-count":32,"publisher":"American Diabetes Association","issue":"6","license":[{"start":{"date-parts":[[2020,5,20]],"date-time":"2020-05-20T00:00:00Z","timestamp":1589932800000},"content-version":"vor","delay-in-days":35,"URL":"https:\/\/www.diabetesjournals.org\/content\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,6,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>In this phase 3, open-label, multicenter trial, 321 patients with HbA1c\u22657.5 to \u226410.0% (58\u201386 mmol\/mol) and fasting plasma glucose (FPG) \u226413.8 mmol\/L (250 mg\/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA1c at week 26.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>Change in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (\u22121.58% [\u221217.3 mmol\/mol]) than with Lixi (\u22120.51% [\u22125.6 mmol\/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference \u22121.07% [\u221211.7 mmol\/mol], P &amp;lt; 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c &amp;lt;7% (53 mmol\/mol) (65.2% vs. 19.4%; P &amp;lt; 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference \u22122.29 mmol\/L [\u221241.23 mg\/dL], P &amp;lt; 0.0001). Incidence of documented symptomatic hypoglycemia (\u22643.9 mmol\/L [70 mg\/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc19-2452","type":"journal-article","created":{"date-parts":[[2020,4,15]],"date-time":"2020-04-15T23:25:25Z","timestamp":1586993125000},"page":"1249-1257","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":37,"title":["Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial"],"prefix":"10.2337","volume":"43","clinical-trial-number":[{"clinical-trial-number":"nct02749890","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct02749890","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5961-1816","authenticated-orcid":false,"given":"Hirotaka","family":"Watada","sequence":"first","affiliation":[{"name":"Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akane","family":"Takami","sequence":"additional","affiliation":[{"name":"Research & Development, Sanofi K.K., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Spranger","sequence":"additional","affiliation":[{"name":"Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Amano","sequence":"additional","affiliation":[{"name":"Research & Development, Sanofi K.K., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Research & Development, Sanofi K.K., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Niemoeller","sequence":"additional","affiliation":[{"name":"Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2020,4,15]]},"reference":[{"key":"2022031300335375700_B1","unstructured":"Ministry of Health, Labour and Welfare\n          . 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