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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EIn the Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation [PREDICTIVE 303] trial, patient-directed insulin dose adjustments of once-daily insulin detemir appeared to be a safe and effective alternative to physician-directed dose adjustments in a primary care setting.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Einsulin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes \u0026amp; endocrinology clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ediabetes mellitus\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EIn PREDICTIVE 303 (Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation), patient-directed insulin dose adjustments of once-daily insulin detemir appeared to be a safe and effective alternative to physician-directed dose adjustments in a primary care setting.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThe primary objective of PREDICTIVE 303, stated lead investigator Luigi F Meneghini, MD, Diabetes Research Institute, University of Miami Miller School of Medicine, Florida, United States, was to show that patient self-adjusted dosing using insulin detemir and a simplified algorithm (Group 1) was non-inferior to physician-directed standard-of-care dosing (Group 2). Detemir was started in either group once daily at bedtime as an add-on therapy to any other glucose-lowering regimens, or as a replacement of previous basal insulin in patients with type 2 diabetes. The primary outcome measure was HbA1c reduction from baseline.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ERandomization was done at the site level. Patients from sites assigned to Group 1 adjusted their detemir dose every 3 days based on mean fasting blood glucose (FBG) values using the following simplified algorithm: mean FBG \u0026lt;4.4 mmol\/L, reduce dose by 3U; FBG between 4.4 and 6.1 mmol\/L, no change; FBG \u0026gt;6.1 mmol\/L, increase by 3U. Detemir dose for Group 2 patients was adjusted by physicians according to the standard of care.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EMean baseline HbA1c was 8.5%. At 26 weeks, mean HbA1c was 7.9% for patients in Group 1 and 8.0% in patients in Group 2 group (p=0.01 between groups; p\u0026lt;0.0001 vs baseline for both groups). FBG, which was 9.7 mmol\/L (178 mg\/dL) at baseline, dropped to 7.8 mmol\/L (143 mg\/dL) in patients in Group 1 and to 8.4 mmol\/L (154 mg\/dL) in Group 2 patients (p\u0026lt;0.0001 between groups; p\u0026lt;0.0001 versus baseline for both groups). As expected, the reductions in HbA1c observed in the insulin-na\u00efve subjects in Group 1 and Group 2 were substantially greater, with no significant differences between groups (\u22121.1% vs \u22121.0%, respectively; p=0.09 between groups; p\u0026lt;0.0001 vs baseline for both groups)\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EAt 26 weeks most patients (88%) remained on once-daily insulin detemir (91% in Group 1, 85% in Group 2). The mean daily insulin detemir dose at 26 weeks was 0.7 and 0.5 U\/kg, in Groups 1 and 2, respectively. Among insulin-na\u00efve patients, rates of once-daily insulin detemir dosing were higher (95% in Group 1, 92% in Group 2).\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EAt study end, the overall rates of daytime and major hypoglycemia (event\/patient\/year) were significantly reduced in both groups versus baseline (p\u0026lt;0.05). Daytime, nocturnal and overall hypoglycemia were significantly lower Group 2 versus Group 1 (p\u0026lt;0.0001). Weight remained constant in Group 1 but dropped from 98.2 kg to 97.9 kg in Group 2.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EIn summary, Prof. Meneghini said that basal insulin titration was successfully carried out in primary care practices. \u201cCompared with standard-of-care, the 303 Algorithm resulted in better or equal improvement in glycemia with slightly greater incidence of non-major hypoglycemia, and no significant weight gain.\u201d\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2007 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/7\/6\/11.2.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzm821\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}