{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T09:22:30Z","timestamp":1792142550379,"version":"4.4.0"},"reference-count":17,"publisher":"American Diabetes Association","issue":"11","license":[{"start":{"date-parts":[[2016,10,20]],"date-time":"2016-10-20T00:00:00Z","timestamp":1476921600000},"content-version":"vor","delay-in-days":30,"URL":"http:\/\/www.diabetesjournals.org\/content\/license"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2016,11,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>After a 6-week run-in when iGlar was introduced and\/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg\/m2) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose &amp;lt;100 mg\/dL (&amp;lt;5.6 mmol\/L) up to a maximum dose of 60 units\/day. The primary outcome was change in HbA1c levels at 30 weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>HbA1c decreased from 8.5% (69 mmol\/mol) to 8.1% (65 mmol\/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA1c from baseline compared with iGlar (\u20131.1% vs. \u20130.6%, P &amp;lt; 0.0001), reaching a mean final HbA1c of 6.9% (52 mmol\/mol) compared with 7.5% (58 mmol\/mol) for iGlar. HbA1c &amp;lt;7.0% (53 mmol\/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P &amp;lt; 0.0001). Documented symptomatic hypoglycemia (\u226470 mg\/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc16-1495","type":"journal-article","created":{"date-parts":[[2016,9,21]],"date-time":"2016-09-21T02:29:36Z","timestamp":1474424976000},"page":"1972-1980","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":245,"title":["Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial"],"prefix":"10.2337","volume":"39","clinical-trial-number":[{"clinical-trial-number":"nct02058160","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Vanita R.","family":"Aroda","sequence":"first","affiliation":[{"name":"Medstar Health Research Institute, Hyattsville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julio","family":"Rosenstock","sequence":"additional","affiliation":[{"name":"Dallas Diabetes Research Center at Medical City, Dallas, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Wysham","sequence":"additional","affiliation":[{"name":"Rockwood Clinic, Spokane, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Unger","sequence":"additional","affiliation":[{"name":"Catalina Research Institute, Chino, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diego","family":"Bellido","sequence":"additional","affiliation":[{"name":"Complejo Hospitalario Universitario de Ferrol, A Coru\u00f1a University, A Coru\u00f1a, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Gonz\u00e1lez-G\u00e1lvez","sequence":"additional","affiliation":[{"name":"Instituto Jalisciense de Investigaci\u00f3n en Diabetes y Obesidad S. C., Universidad de Guadalajara, Hospital Civil de Guadalajara \u201cDr. Juan I. Menchaca,\u201d Guadalajara, Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akane","family":"Takami","sequence":"additional","affiliation":[{"name":"Sanofi, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hailing","family":"Guo","sequence":"additional","affiliation":[{"name":"Biostatistics, BMD Consulting Inc., Somerset, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Niemoeller","sequence":"additional","affiliation":[{"name":"Diabetes Division, Sanofi, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Souhami","sequence":"additional","affiliation":[{"name":"Diabetes Division, Sanofi, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard M.","family":"Bergenstal","sequence":"additional","affiliation":[{"name":"International Diabetes Center, Park Nicollet Health Services, Minneapolis, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the LixiLan-L Trial Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2016,9,20]]},"reference":[{"key":"2022031301112510600_B1","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.2337\/dc16-er09","volume":"39","author":"American Diabetes Association","year":"2016","journal-title":"Diabetes Care"},{"key":"2022031301112510600_B2","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1002\/dmrr.733","article-title":"When basal insulin therapy in type 2 diabetes mellitus is not enough--what next","volume":"23","author":"Raccah","year":"2007","journal-title":"Diabetes Metab Res Rev"},{"key":"2022031301112510600_B3","doi-asserted-by":"crossref","first-page":"631","DOI":"10.2337\/diacare.24.4.631","article-title":"Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine 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