{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T07:29:36Z","timestamp":1761895776084,"version":"build-2065373602"},"reference-count":35,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2013,12,29]],"date-time":"2013-12-29T00:00:00Z","timestamp":1388275200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2014,6]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>To compare efficacy and safety of two, once\u2010daily basal insulin formulations [insulin lispro protamine suspension (<jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content>) vs. insulin glargine (glargine)] added to oral antihyperglycaemic medications (<jats:styled-content style=\"fixed-case\">OAMs<\/jats:styled-content>) and exenatide <jats:styled-content style=\"fixed-case\">BID<\/jats:styled-content> in suboptimally controlled type 2 diabetes (<jats:styled-content style=\"fixed-case\">T2D<\/jats:styled-content>) patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This 24\u2010week, open\u2010label, multicentre trial randomized patients to bedtime <jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> (n\u2009=\u2009171) or glargine (n\u2009=\u2009168). Non\u2010inferiority of <jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> versus glargine was assessed by comparing the upper limit of 95% confidence intervals (<jats:styled-content style=\"fixed-case\">CIs<\/jats:styled-content>) for change in haemoglobin A1c (<jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content>) from baseline to week 24 (adjusted for baseline <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content>) with non\u2010inferiority margin 0.4%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Non\u2010inferiority of <jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> versus glargine was demonstrated: least\u2010squares mean between\u2010treatment difference (<jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> minus glargine) (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>) was 0.22% (0.06, 0.38). Mean <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> reduction was less for <jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content>\u2010 versus glargine\u2010treated patients (\u22121.16\u2009\u00b1\u20090.84 vs. \u22121.40\u2009\u00b1\u20090.97%, p\u2009=\u20090.008). Endpoint <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content>\u2009&lt;\u20097.0% was achieved by 53.7% (<jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content>) and 61.7% (glargine) (p\u2009=\u2009<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>). Overall hypoglycaemia rates (p\u2009=\u2009<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>) and severe hypoglycaemia incidence (p\u2009=\u2009<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>) were similar. Nocturnal hypoglycaemia rate was higher in patients treated with <jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> versus glargine (p\u2009=\u20090.004). Weight gain was similar between groups (<jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content>: 0.27\u2009\u00b1\u20093.38\u2009kg; glargine: 0.66\u2009\u00b1\u20093.93\u2009kg, p\u2009=\u2009<jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>). Endpoint total insulin doses were lower in patients treated with <jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> versus glargine (0.30\u2009\u00b1\u20090.17 vs. 0.37\u2009\u00b1\u20090.17\u2009<jats:styled-content style=\"fixed-case\">IU<\/jats:styled-content>\/kg\/day, p\u2009&lt;\u20090.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">ILPS<\/jats:styled-content> was non\u2010inferior to glargine for <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> change over 24\u2009weeks, but was associated with less <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> reduction and more nocturnal hypoglycaemia. Treat\u2010to\u2010target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to <jats:styled-content style=\"fixed-case\">OAMs<\/jats:styled-content> and exenatide <jats:styled-content style=\"fixed-case\">BID<\/jats:styled-content> for suboptimally controlled <jats:styled-content style=\"fixed-case\">T2D<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dom.12242","type":"journal-article","created":{"date-parts":[[2013,12,3]],"date-time":"2013-12-03T13:11:21Z","timestamp":1386076281000},"page":"510-518","source":"Crossref","is-referenced-by-count":11,"title":["Comparison of insulin lispro protamine suspension versus insulin glargine once daily added to oral antihyperglycaemic medications and exenatide in type 2 diabetes: a prospective randomized open\u2010label trial"],"prefix":"10.1111","volume":"16","author":[{"given":"R. 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