{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T12:24:57Z","timestamp":1773923097501,"version":"3.50.1"},"reference-count":31,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2015,9,4]],"date-time":"2015-09-04T00:00:00Z","timestamp":1441324800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004634","name":"Mount Sylvia Diatomite","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004634","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2015,12]]},"abstract":"\n Aim<\/jats:title>\n \n To test the hypothesis that a \u2018basal plus\u2019 regimen\uf8ffadding once\u2010daily main\u2010meal fast\u2010acting insulin to basal insulin once daily\uf8ffwould be non\u2010inferior to biphasic insulin twice daily as assessed by glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) concentration (predefined as \u22640.4%), but would provide superior treatment satisfaction.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This open\u2010label trial enrolled adults to an 8\u2010 or 12\u2010week run\u2010in period, during which oral therapies except metformin were stopped and insulin glargine dose was titrated. Those with fasting glucose <7\u2009mmol\/l but\n HbA1c<\/jats:styled-content>\n >7% (53\u2009mmol\/mol) were randomized to insulin glargine\/glulisine once daily (n\u2009=\u2009170) or insulin aspart\/aspart protamine 30\/70 twice daily (n\u2009=\u2009165) for 24\u2009weeks, with dose titration to glucose targets using standardized algorithms.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n For\n HbA1c<\/jats:styled-content>\n , the basal plus regimen was non\u2010inferior to biphasic insulin (least squares mean difference, 0.21%, upper 97.5% confidence limit 0.38%) meeting the predefined non\u2010inferiority margin of 0.4%. Treatment satisfaction (\n D<\/jats:styled-content>\n iabetes\n T<\/jats:styled-content>\n reatment\n S<\/jats:styled-content>\n atisfaction\n Q<\/jats:styled-content>\n uestionnaire change version and\n I<\/jats:styled-content>\n nsulin\n T<\/jats:styled-content>\n reatment\n S<\/jats:styled-content>\n atisfaction\n Q<\/jats:styled-content>\n uestionnaire total scores) significantly favoured basal plus. No difference was observed between the basal plus and the biphasic insulin groups in responders (\n HbA1c<\/jats:styled-content>\n <7%, 20.6 vs 27.9%; p\u2009=\u20090.12), weight gain (2.06 vs 2.50\u2009kg; p\u2009=\u20090.2), diabetes\u2010specific quality of life (\n A<\/jats:styled-content>\n udit of\n D<\/jats:styled-content>\n iabetes\u2010\n D<\/jats:styled-content>\n ependent\n Q<\/jats:styled-content>\n uality of\n L<\/jats:styled-content>\n ife average weighted impact (AWI) score) and generic health status (five\u2010dimension\n E<\/jats:styled-content>\n uropean\n Q<\/jats:styled-content>\n uality of\n L<\/jats:styled-content>\n ife questionnaire). Overall hypoglycaemia rates were similar between groups (15.3 vs 18.2 events\/patient\u2010year; p\u2009=\u20090.22); nocturnal hypoglycaemia was higher with the basal plus regimen (5.7 vs 3.6 events\/patient\u2010year; p\u2009=\u20090.02).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n In long\u2010standing type 2 diabetes with suboptimal glycaemia despite oral therapies and basal insulin, the basal plus regimen was non\u2010inferior to biphasic insulin for biomedical outcomes, with a similar overall hypoglycaemia rate but more nocturnal events.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12528","type":"journal-article","created":{"date-parts":[[2015,6,18]],"date-time":"2015-06-18T05:59:14Z","timestamp":1434607154000},"page":"1133-1141","source":"Crossref","is-referenced-by-count":41,"title":["Intensifying insulin regimen after basal insulin optimization in adults with type 2 diabetes: a 24\u2010week, randomized, open\u2010label trial comparing insulin glargine plus insulin glulisine with biphasic insulin aspart (\n L<\/scp>\n anScape)"],"prefix":"10.1111","volume":"17","author":[{"given":"J.","family":"Vora","sequence":"first","affiliation":[{"name":"Royal Liverpool University Hospital Liverpool UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Baker IDI Heart & Diabetes Institute Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Evans","sequence":"additional","affiliation":[{"name":"University Hospital Llandough UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Hockey","sequence":"additional","affiliation":[{"name":"Sanofi Guildford UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Speight","sequence":"additional","affiliation":[{"name":"AHP Research Hornchurch UK"},{"name":"The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria Melbourne Australia"},{"name":"School of Psychology, Deakin University Burwood Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Whately\u2010Smith","sequence":"additional","affiliation":[{"name":"Whately\u2010Smith Ltd King's Langley UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,9,4]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.21.2005"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0806470"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.11.3080"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0413"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2007.07.003"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/11635490-000000000-00000"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200666010-00003"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejim.2006.09.006"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa075392"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905479"},{"key":"e_1_2_8_12_1","first-page":"111","volume-title":"Handbook of Psychology and Diabetes: A Guide to Psychological Measurement in Diabetes Research and Practice","author":"Bradley C","year":"1994"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.3.530"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(04)90059-8"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1026485130100"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.279"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/0168-8510(90)90421-9"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/0168-8510(96)00822-6"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1099-1050(199603)5:2<141::AID-HEC189>3.0.CO;2-N"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199711000-00002"},{"key":"e_1_2_8_21_1","unstructured":"European Medicines Agency.Committee for proprietary medicinal products. 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