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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EA long-acting basal insulin glargine formulation, 300 U\/mL (Gla-300), controlled glycemia as well as insulin glargine 100 U\/mL (Gla-100) in patients with type 2 diabetes mellitus (T2DM) but with less nocturnal hypoglycemia. This article presents findings from a Phase 3 multicenter, open-label [EDITION I; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01499082\u0026amp;atom=%2Fspmdc%2F13%2F17%2F25.atom\u0022\u003ENCT01499082\u003C\/a\u003E] study comparing the two insulin glargine formulations in patients with T2DM who were using basal plus mealtime insulin.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInsulin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHyperglycemia\/Hypoglycemia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Endocrinology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInsulin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEndocrinology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Metabolic Syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHyperglycemia\/Hypoglycemia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA long-acting basal insulin glargine formulation, 300 U\/mL (Gla-300), controlled glycemia as well as insulin glargine 100 U\/mL (Gla-100) in patients with type 2 diabetes mellitus (T2DM) but with less nocturnal hypoglycemia. Matthew C. Riddle, MD, Oregon Health \u0026amp; Science University, Portland, Oregon, USA, presented findings from a Phase 3 multicenter, open-label study comparing the two insulin glargine formulations in patients with T2DM who were using basal plus mealtime insulin.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EGla-100 is a widely used basal insulin with no pronounced peak of action and a duration of action of \u223c24 hours; it causes less hypoglycemia than human neutral protamine Hagedorn (NPH) insulin [Riddle MC et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2003]. The investigational insulin glargine (Gla-300) contains the same molecule as Gla-100 but in a lower volume. It has a flatter and more prolonged pharmacokinetic and pharmacodynamics profile than Gla-100 [Jax T et al. EASD 2013 (abstr 1029)]. Whether or not the differences in pharmacokinetics between Gla-100 and Gla-300 translate into a clinical benefit is being tested in a worldwide series of Phase 3 studies in several populations of patients with type 1 diabetes mellitus and T2DM. The data presented here from the Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin [EDITION I; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01499082\u0026amp;atom=%2Fspmdc%2F13%2F17%2F25.atom\u0022\u003ENCT01499082\u003C\/a\u003E] were the first from this series of Phase 3 trials.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAdults (n=807) with T2DM on a basal-bolus insulin regimen that included at least 42 U\/day of basal glargine or NPH insulin were randomized to 6 months of open-label treatment with either Gla-300 or Gla-100 once daily in the evening while continuing mealtime insulin. The basal insulin was titrated weekly to achieve a fasting plasma glucose of 80 to 100 mg\/dL. Mealtime insulin dosage was not systematically titrated, with adjustments made at investigators\u0027 discretion only for safety reasons.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ESubjects\u0027 mean age was 60 years, their mean duration of diabetes was 15.8 years, and their mean body mass index was 36.6 kg\/m\u003Csup\u003E2\u003C\/sup\u003E. More than half of the patients were using metformin. On entry, the mean basal insulin dose was 0.67 U\/kg\/day and the mean total insulin dose was 1kg\/day. The mean baseline HbA1C level was 8.16%.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary endpoint, the change in HbA1C from baseline to Month 6, was \u22120.83% in both the Gla-100 and Gla-300 groups, the 0.0% difference met the criterion for noninferiority of Gla-300. There were no differences between the treatments in other glycemic control outcomes.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe chief secondary endpoint was percentage of people with \u22651 severe or confirmed episodes of nocturnal hypoglycemia from Month 3 to Month 6. Fewer people assigned to Gla-300 experienced severe or confirmed nocturnal hypoglycemia during Months 3 to 6 (36.1% vs 46.0%, representing a 21% reduction in relative risk; p=0.0070). The occurrence of any hypoglycemic event during study period was numerically lower in the Gla-300 group than in the Gla-100 group.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThere were no between-treatment differences in weight change, adverse events, serious adverse events, adverse events causing withdrawal, injection-site reactions, and mortality.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EDr. Riddle concluded that in patients with T2DM who require high-dose basal-bolus insulin therapy, Gla-300 was as effective as Gla-100 in blood glucose control and was associated with a reduction in severe or confirmed nocturnal hypoglycemia.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\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\/13\/17\/25.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?nznlgd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}