uni-leipzig-open-access/json/dom.14907

{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,18]],"date-time":"2024-01-18T22:44:50Z","timestamp":1705617890208},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,11,23]],"date-time":"2022-11-23T00:00:00Z","timestamp":1669161600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To report prespecified and post hoc analyses of the SoliMix dataset exploring the impact of baseline participant characteristics on the original SoliMix study outcomes, to enable informed treatment choices for people with different biomedical characteristics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>SoliMix (EudraCT 2017\u2010003370\u201013) compared once\u2010daily iGlarLixi (a fixed\u2010ratio combination of insulin glargine 100\u2009U\/mL and the glucagon\u2010like peptide\u20101 receptor agonist lixisenatide) with twice\u2010daily BIAsp 30 (30% insulin aspart and 70% insulin aspart protamine). In this analysis, the original primary outcomes of noninferiority of iGlarLixi versus BIAsp 30 in terms of glycated haemoglobin (HbA1c) change and superiority in terms of body weight change, together with change in basal insulin dose and hypoglycaemia outcomes, were investigated by baseline age, duration of diabetes, insulin dose, HbA1c level, body mass index (BMI), and renal function.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>No evidence of difference in comparative treatment effect was detected across baseline age, duration of diabetes, insulin dose, HbA1c level, BMI and renal function subgroups for any endpoint (all heterogeneity <jats:italic>P<\/jats:italic>\u00a0&gt;\u20090.05), except American Diabetes Association Level 2 hypoglycaemia event rate when stratified by insulin dose (<jats:italic>P<\/jats:italic>\u00a0=\u20090.011), which may be a chance difference given multiple testing and the small numbers of Level 2 events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Treatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes and renal function, supporting the use of iGlarLixi as an efficacious and well\u2010tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dom.14907","type":"journal-article","created":{"date-parts":[[2022,10,30]],"date-time":"2022-10-30T15:33:15Z","timestamp":1667143995000},"page":"656-663","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Findings for <scp>iGlarLixi<\/scp> versus <scp>BIAsp<\/scp> 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics"],"prefix":"10.1111","volume":"25","author":[{"given":"Philip D.","family":"Home","sequence":"first","affiliation":[{"name":"Translational and Clinical Research Institute Newcastle University  Newcastle upon Tyne UK"}]},{"ORCID":"http:\/\/orcid.org\/0000-0002-3957-1981","authenticated-orcid":false,"given":"Rory J.","family":"McCrimmon","sequence":"additional","affiliation":[{"name":"Division of Systems Medicine School of Medicine, University of Dundee  Dundee UK"}]},{"ORCID":"http:\/\/orcid.org\/0000-0001-8324-3275","authenticated-orcid":false,"given":"Julio","family":"Rosenstock","sequence":"additional","affiliation":[{"name":"Velocity Clinical Research at Medical City  Dallas Texas USA"}]},{"given":"Matthias","family":"Bl\u00fcher","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Leipzig  Leipzig Germany"}]},{"given":"Katrin","family":"Pegelow","sequence":"additional","affiliation":[{"name":"Sanofi  Berlin Germany"}]},{"given":"Lydie","family":"Melas\u2010Melt","sequence":"additional","affiliation":[{"name":"IVIDATA Life Sciences  Levallois\u2010Perret France"}]},{"given":"Khier","family":"Djaballah","sequence":"additional","affiliation":[{"name":"Sanofi  Paris France"}]},{"ORCID":"http:\/\/orcid.org\/0000-0001-7372-2678","authenticated-orcid":false,"given":"Francesco","family":"Giorgino","sequence":"additional","affiliation":[{"name":"Department of Emergency and Organ Transplantation Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro  Bari Italy"}]},{"name":"the SoliMix trial 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