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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\u003EExenatide therapy in patients with type 2 diabetes who take metformin requires twice-daily self-injections and is associated with significant nausea and vomiting [Pinelli NR, Hurren KM. \u003Cem\u003EAnn Pharmacother\u003C\/em\u003E 2011]. Continuous delivery of exenatide was evaluated in a Phase 2, randomized study with ITCA 650, a subcutaneous osmotic delivery system that provides constant delivery of exenatide at specified doses [ITCA 650; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00943917\u0026amp;atom=%2Fspmdc%2F11%2F8%2F12.atom\u0022\u003ENCT00943917\u003C\/a\u003E].\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\u003EDiabetes Mellitus\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EExenatide therapy in patients with type 2 diabetes who take metformin requires twice-daily self-injections and is associated with significant nausea and vomiting [Pinelli NR, Hurren KM. \u003Cem\u003EAnn Pharmacother 2011\u003C\/em\u003E]. Continuous delivery of exenatide was evaluated in a Phase 2, randomized study with ITCA 650, a subcutaneous osmotic delivery system that provides constant delivery of exenatide at specified doses [ITCA 650; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00943917\u0026amp;atom=%2Fspmdc%2F11%2F8%2F12.atom\u0022\u003ENCT00943917\u003C\/a\u003E]. Julio Rosenstock, MD, University of Texas Southwestern Medical School, Dallas, Texas, USA, presented findings from the study.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe primary outcome for the 24-week, randomized, multicenter trial was efficacy of specific doses of ITCA 650. Eligibility criteria included males or females aged 18 to 70 years with type 2 diabetes mellitus for \u22656 months prior to Screening Visit 1; a stable (\u0026gt;3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy; fasting plasma glucose \u0026lt;240 mg\/dL at Screening Visit 1; and HbA1C \u22657% and \u226410% at Screening Visit 1.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EExclusion criteria included prior treatment with exenatide, TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled); history of type 1 diabetes and\/or diabetic ketoacidosis; body mass index \u226540 kg\/m\u003Csup\u003E2\u003C\/sup\u003E; and history of organ transplantation.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ESubjects (n=155) were randomized to receive ITCA 650, implanted every 3 months at 20, 40, 60, or 80 mcg\/day following 12 weeks of either ITCA 650 (20 or 40 mcg\/day) or exenatide injections (10 mcg BID). At Week 12, the completion rate for ITCA 650 was 93% versus 89% for exenatide injections; respective withdrawals due to nausea were 3.9% versus 5.7%.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAt Week 24, subjects were offered the option to continue treatment at their current dose for an additional 24 weeks; 85% of eligible subjects elected to continue treatment. During the 6-month extension, HbA1C and body weight reductions were sustained. No subjects withdrew for any reason. One patient reported nausea; none reported vomiting. No cases of hypoglycemia occurred.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESignificant reductions in HbA1C (p\u0026lt;0.0001 for all does groups) and weight (p\u0026lt;0.001 for the 40 mcg\/day dose and p\u0026lt;0.05 for all other doses) at Week 48 were maintained from those that were initially observed at Week 24. Desirable trends in lipids and blood pressure were also noted. Changes that were seen at 60 mcg\/day, the long-term dose that was selected for future studies, were \u22123.1% for total cholesterol, \u22129.9% for triglycerides, \u22125.2% for low-density lipoprotein cholesterol, \u22121.7 mm Hg for systolic blood pressure, and \u22127.8 mm Hg for diastolic blood pressure. High-density lipoprotein cholesterol increased by 0.5%. Continuing treatment with ITCA 650 was very well tolerated, with minimal side effects and a completion rate of 85%.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EStudy delivery technology consisted of sterile, nonbiodegradable, single-use devices for continuous, subcutaneous administration of therapeutic molecules at steady rates. It is capable of delivering a wide range of therapeutic molecules for durations that range from 3 to 12 months [Rohloff CM et al. \u003Cem\u003EJ Diabetes Sci Technol\u003C\/em\u003E 2008].\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThis extension study shows that long-term treatment with ITCA 650 is effective in controlling glycemic parameters and weight and can also lead to potentially positive cardiovascular benefits through beneficial changes in lipids and blood pressure. In addition, tolerability is excellent, with minimal gastrointestinal side effects. Phase 3 studies will evaluate chronic treatment with ITCA 650 using devices of 6 to 12 months in duration.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 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\/11\/8\/12.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?nzn1bd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}