{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T00:25:31Z","timestamp":1780964731866,"version":"3.54.1"},"reference-count":29,"publisher":"Wiley","issue":"S2","license":[{"start":{"date-parts":[[2016,10,10]],"date-time":"2016-10-10T00:00:00Z","timestamp":1476057600000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"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":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2016,10]]},"abstract":"\n Aims<\/jats:title>\n \n Basal insulin peglispro (\n BIL<\/jats:styled-content>\n ) has a longer duration of action than conventional insulin analogues and a hepato\u2010preferential mechanism of action. This study assessed whether\n BIL<\/jats:styled-content>\n was non\u2010inferior to isophane insulin (\n NPH<\/jats:styled-content>\n ) in reducing\n HbA1c<\/jats:styled-content>\n in insulin\u2010na\u00efve patients with type 2 diabetes, when added to pre\u2010study oral anti\u2010hyperglycaemic medications.\n <\/jats:p>\n <\/jats:sec>\n \n Materials and methods<\/jats:title>\n \n This was a Phase 3, open\u2010label, treat\u2010to\u2010target (\n TTT<\/jats:styled-content>\n ), randomized trial with a 2\u2010week lead\u2010in, 26\u2010week treatment and a 4\u2010week safety follow\u2010up period. Patients were randomized to bedtime (\n pm<\/jats:sc>\n )\n NPH<\/jats:styled-content>\n , morning (\n am<\/jats:sc>\n )\n BIL<\/jats:styled-content>\n or\n pm<\/jats:sc>\n BIL<\/jats:styled-content>\n in a 1:1:1 ratio.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Six hundred and forty\u2010one patients [\n NPH<\/jats:styled-content>\n ,\n n<\/jats:italic>\n \u2009=\u2009213;\n BIL<\/jats:styled-content>\n ,\n n<\/jats:italic>\n \u2009=\u2009428 (\n am<\/jats:sc>\n ,\n n<\/jats:italic>\n \u2009=\u2009213;\n pm<\/jats:sc>\n ,\n n<\/jats:italic>\n \u2009=\u2009215)] received study drug.\n BIL<\/jats:styled-content>\n was non\u2010inferior to\n NPH<\/jats:styled-content>\n for\n HbA1c<\/jats:styled-content>\n change from baseline at Week 26 with a between\u2010treatment difference (95% confidence interval) of \u22120.37% (\u22120.50, \u22120.23%).\n HbA1c<\/jats:styled-content>\n at baseline was 8.5%, and was lower in\n BIL<\/jats:styled-content>\n \u2010 vs\n NPH<\/jats:styled-content>\n \u2010treated patients after 26 weeks of treatment (6.8% vs 7.1%;\n P<\/jats:italic>\n \u2009<\u2009.001). More\n BIL<\/jats:styled-content>\n \u2010treated patients achieved\n HbA1c<\/jats:styled-content>\n <7.0% and\n HbA1c<\/jats:styled-content>\n <7.0% without nocturnal hypoglycaemia. Fasting serum glucose levels and nocturnal hypoglycaemia rates were lower in\n BIL<\/jats:styled-content>\n \u2010treated patients; total hypoglycaemia rates were similar. Treatment\u2010emergent adverse events were similar between groups. Fasting triglycerides decreased from baseline in both groups and to a greater extent with\n NPH<\/jats:styled-content>\n , but were not significantly different between groups at Week 26. Mean\n alanine aminotransferase (ALT)<\/jats:styled-content>\n increased with\n BIL<\/jats:styled-content>\n treatment, but there was no evidence of acute severe hepatotoxicity.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n In this\n TTT<\/jats:styled-content>\n study,\n BIL<\/jats:styled-content>\n treatment showed clinically relevant improvements in glycaemic control and a significant reduction in nocturnal hypoglycaemia compared to\n NPH<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12743","type":"journal-article","created":{"date-parts":[[2016,10,13]],"date-time":"2016-10-13T06:39:20Z","timestamp":1476340760000},"page":"34-42","source":"Crossref","is-referenced-by-count":12,"title":["A randomized clinical trial of basal insulin peglispro vs\n NPH<\/scp>\n in insulin\u2010na\u00efve patients with type 2 diabetes: the\n IMAGINE<\/scp>\n 6 trial"],"prefix":"10.1111","volume":"18","author":[{"given":"G.","family":"Grunberger","sequence":"first","affiliation":[{"name":"Grunberger Diabetes Institute Bloomfield Hills Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Chen","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Alcobendas Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. J.","family":"Tinahones","sequence":"additional","affiliation":[{"name":"Hospital Virgen de la Victoria Malaga Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. J.","family":"Jacober","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Bue\u2010Valleskey","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the IMAGINE 6 Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,10,10]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"National Institute for Health and Care Excellence.NICE Clinical Guidance. Type 2 Diabetes: the Management of Type 2 Diabetes. National Institute for Health and Care Excellence; 2016.https:\/\/www.nice.org.uk\/guidance\/ng28Accessed August 1 2016."},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0413"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.21.2005"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)07019-6"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2258"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12256"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.11.3080"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc05-1365"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-005-0132-0"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12129"},{"key":"e_1_2_6_12_1","unstructured":"BealsJ CutlerG DoyleB et al.PEGylated Insulin lispro compounds. PEGylated insulin lispro compounds. United States patent US 2009\/0312236 A1; 2009."},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12222"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0210"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12712"},{"key":"e_1_2_6_16_1","unstructured":"World Health Organization. Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia.2006.http:\/\/www.who.int\/diabetes\/publications\/Definition%20and%20diagnosis%20of%20diabetes_new.pdf. Accessed May 12 2015."},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.200710464"},{"key":"e_1_2_6_18_1","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry drug\u2010induced liver injury: premarketing clinical evaluation.2009.http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM174090.pdf. Accessed May 12 2015."},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-1531"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12696"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12072"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2011.621416"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0060"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0067"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.276"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.2337\/db13-0826"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12691"},{"issue":"1","key":"e_1_2_6_28_1","first-page":"S65","article-title":"No difference in major adverse cardiovascular events (MACE+) with basal insulin peglispro (BIL) vs comparator insulins in patients with type 1 or type 2 diabetes","volume":"58","author":"Bergenstal RM","year":"2015","journal-title":"Diabetologia"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27395"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12751"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.12743","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.12743","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.12743","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:52:03Z","timestamp":1761864723000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.12743"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,10]]},"references-count":29,"journal-issue":{"issue":"S2","published-print":{"date-parts":[[2016,10]]}},"alternative-id":["10.1111\/dom.12743"],"URL":"https:\/\/doi.org\/10.1111\/dom.12743","archive":["Portico"],"relation":{},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,10]]}}}