{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T20:24:18Z","timestamp":1779913458549,"version":"3.53.1"},"reference-count":16,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2012,8,13]],"date-time":"2012-08-13T00:00:00Z","timestamp":1344816000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetic Medicine"],"published-print":{"date-parts":[[2012,9]]},"abstract":"<jats:sec><jats:label\/><jats:p>Diabet. Med. 29, e263\u2010e272 (2012)<\/jats:p><\/jats:sec><jats:sec><jats:title>Abstract<\/jats:title><jats:p><jats:bold>Aims\u2002<\/jats:bold> To test the hypothesis that initiation and intensification with 25% insulin lispro, 75% insulin lispro protamine suspension (LM25), is non\u2010inferior to initiation and intensification with glargine\u2003+\u2003insulin lispro therapy on change from baseline in HbA<jats:sub>1c<\/jats:sub>.<\/jats:p><jats:p><jats:bold>Methods\u2002<\/jats:bold> In this randomized, non\u2010inferiority (margin of 0.4%), parallel, prospective, multi\u2010country, 48\u2010week, open\u2010label study, patients (<jats:italic>n<\/jats:italic>\u2003=\u2003426) with Type\u20032 diabetes inadequately controlled with oral anti\u2010hyperglycaemic medications were assigned to either initiating therapy with one daily LM25 injection, progressing up to three daily injections (full analysis set <jats:italic>n<\/jats:italic>\u2003=\u2003211; per protocol set <jats:italic>n<\/jats:italic>\u2003=\u2003177) or initiating therapy with one daily glargine injection and progressing up to three daily insulin lispro injections (full analysis set <jats:italic>n<\/jats:italic>\u2003=\u2003212; per protocol set <jats:italic>n<\/jats:italic>\u2003=\u2003184).<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> LM25 therapy was found to be non\u2010inferior to glargine\u2003+\u2003insulin lispro therapy by study end (upper limit of 95%\u2003CI &lt;\u20030.4), with a least\u2010squares mean difference (95%\u2003CI) in HbA<jats:sub>1c<\/jats:sub> (LM25 minus glargine\u2003+\u2003insulin lispro) of \u22120.4\u2003mmol\/mol (95%\u2003CI \u22122.7 to 1.9); \u22120.04% (95%\u2003CI \u22120.25 to 0.17). No statistically significant differences between treatment groups were found in the percentage of patients achieving HbA<jats:sub>1c<\/jats:sub> targets or postprandial blood glucose levels. The increase in insulin dose, number of injections and weight change during the course of the study were similar in both groups. Patients in both groups experienced similar hypoglycaemia rates and safety profile.<\/jats:p><jats:p><jats:bold>Conclusions\u2002<\/jats:bold> For patients with Type\u20032 diabetes inadequately controlled with oral anti\u2010hyperglycaemic medications, glycaemic control when initiating and intensifying with LM25 therapy was found to be non\u2010inferior to treatment with glargine\u2003+\u2003insulin lispro therapy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1464-5491.2012.03722.x","type":"journal-article","created":{"date-parts":[[2012,6,5]],"date-time":"2012-06-05T19:01:57Z","timestamp":1338922917000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type\u20032 diabetes who have inadequate glycaemic control on oral anti\u2010hyperglycaemic medication: results of the PARADIGM study"],"prefix":"10.1111","volume":"29","author":[{"given":"K.","family":"Bowering","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V. 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