{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T22:51:59Z","timestamp":1761519119533,"version":"3.41.2"},"reference-count":32,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Diab Res Care"],"accepted":{"date-parts":[[2015,4,1]]},"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:sec>\n                  <jats:title>Aim<\/jats:title>\n                  <jats:p>Describe the characteristics of patients initiating human regular U-500 insulin (U-500R) and their subsequent glycemic control in a real-world setting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>US Humedica electronic health record system data (July 2007\u2013September 2011) were used to identify patients with diabetes aged \u226518\u2005years with \u22651 records for U-500R prescriptions, 6\u2005months of preindex data, 12\u2005months following first use of U-500R, and at least one glycated hemoglobin (HbA1c) value in both preindex and postindex periods. Paired t tests were used to measure the change in HbA1c from preindex to postindex periods (last or most recent values) and hypoglycemia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among patients initiating U-500R (N=445), 96.9% had type 2 diabetes with mean age 57\u2005years and mean body mass index 40.4\u2005kg\/m<jats:sup>2<\/jats:sup>. Postindex prescriptions were written for U-500R alone (47.0%, group A) and concomitant U-500R\/U-100 insulins (53.0%, group B). Concomitant oral antihyperglycemic agents (AHAs) and non-insulin injectable AHAs were used by 43.4% and 14.6% of patients, respectively. Following initiation of U-500R, mean HbA1c improved 0.68% in all patients (p&lt;0.0001 compared with baseline), but the decrease in HbA1c did not differ significantly between groups (A: 0.78%; B: 0.60%). Overall, hypoglycemic events, largely captured in the outpatient setting, increased in incidence from 6.7% to 11.9% (p\u22640.0001) and from 0.23 to 0.39 events\/patient\/year, an increase of 0.16 (p=0.003), from preindex to postindex.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This real-world outcomes analysis demonstrates that U-500R initiation is associated with a clinically meaningful improvement in glycemic control over the subsequent 12-month period with modest increase in incidence and rate of hypoglycemia.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjdrc-2014-000074","type":"journal-article","created":{"date-parts":[[2015,5,1]],"date-time":"2015-05-01T20:11:53Z","timestamp":1430511113000},"page":"e000074","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":18,"title":["Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study"],"prefix":"10.1136","volume":"3","author":[{"given":"Elizabeth L","family":"Eby","sequence":"first","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bradley H","family":"Curtis","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven C","family":"Gelwicks","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert C","family":"Hood","sequence":"additional","affiliation":[{"name":"Endocrine Clinic of Southeast Texas, Beaumont, Texas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iskandar","family":"Idris","sequence":"additional","affiliation":[{"name":"School of Graduate Entry Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne L","family":"Peters","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard M","family":"Bergenstal","sequence":"additional","affiliation":[{"name":"International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey A","family":"Jackson","sequence":"additional","affiliation":[{"name":"Lilly USA, LLC, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2015,4,30]]},"reference":[{"key":"2025073111585140000_3.1.e000074.1","unstructured":"Humulin\u00ae R regular U-500 [package insert]. 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