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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\u003EThis article provides an update on new and emerging therapies for type 2 diabetes mellitus.\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 Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHyperglycemia\/Hypoglycemia Diabetes \u0026amp; Metabolic Syndrome\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInsulin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHyperglycemia\/Hypoglycemia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEndocrinology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Metabolic Syndrome\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ECurtis L. Triplitt, PharmD, CDE, University of Texas, San Antonio, Texas, USA, and Joshua J. Neumiller, PharmD, CDE, Washington State University, Spokane, Washington, USA, provided an update on new and emerging therapies for type 2 diabetes mellitus (T2DM).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAccording to Dr. Neumiller, a better understanding of the pathophysiology of T2DM has expanded the armamentarium of drugs to treat hypoglycemia. The glycemic control algorithm established by the American Association of Clinical Endocrinologists in 2013 favors lifestyle modifications. If the baseline HbA\u003Csub\u003E1c\u003C\/sub\u003E level is \u0026lt; 7.5%, monotherapy with metformin is the preferred treatment strategy [Garber AJ et al. \u003Cem\u003EAACE Comprehensive Diabetes Management Algorithm\u003C\/em\u003E 2013]. Although there are many options for add-on therapy, the final choice of agent(s) should take into consideration factors such as hypoglycemia risk, weight-gain potential, side effect profile, and cost. Patients with higher entry HbA\u003Csub\u003E1c\u003C\/sub\u003E levels of \u22657.5% and \u0026gt;9.0% will require dual and triple therapy, respectively. In addition, patients who do not meet their initial HbA\u003Csub\u003E1c\u003C\/sub\u003E goals within 3 months of therapy should have their treatment uptitrated.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDr. Triplitt reviewed new insulin therapies, some of which are still being developed. Insulin degludec is an ultra-long-acting basal insulin approved for once-daily dosing in adults with type 1 diabetes mellitus and T2DM in the European Union, Japan, and Mexico. It is not currently approved for use in the United States. The agent is associated with less nocturnal hypoglycemia when given daily compared with insulin glargine. Phase 2 trials had suggested that injection of insulin degludec 3 times a week provided similar control to once-daily insulin glargine. However, data from 2 Phase 3 trials suggested that insulin degludec provided inferior glycemic control and an increased risk for hypoglycemia [Zinman B et al. \u003Cem\u003ELancet Diabetes Endocrinol\u003C\/em\u003E 2013]. The cardiovascular (CV) safety of insulin degludec is still under investigation, since initial clinical trials raised the possibility that this agent may increase cardiovascular risk.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EU300 insulin glargine is a new, longer lasting formulation of insulin glargine that is also under development. Blood glucose control is similar between U300 and the older insulin glargine, but rates of hypoglycemia and nocturnal hypoglycemia have been lower with U300 [Riddle MC et al. American Diabetes Association Scientific Sessions 2014; (abstract 81-LB)].\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EPEGylated insulin Lispro (LY2605541) is a novel, long-acting basal insulin designed to be dosed once daily in patients with T2DM. In a randomized Phase 2 trial, LY2605541 was compared with glargine in 288 adults with T2DM who had blood glucose levels not at target despite treatment with metformin. In this trial, the daily mean blood glucose level was significantly lower with LY2605541 (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E) [Bergenstal RM et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2012]. There were no significant differences in fasting blood glucose (p = .388), fasting serum glucose (p = .8812), or change in HbA\u003Csub\u003E1c\u003C\/sub\u003E level (p = .197). At Week 12, mean body weight was .8 kg lower (p = .001) in patients who received LY2605541.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15033\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15033\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15033\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003ELY2605541 Versus Insulin Glargine at Week 12\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003ETechnosphere insulin (insulin human inhalation powder) is a powdered insulin that is inhaled and delivered deep into the lungs. The drug has properties that are similar to those of intravenous insulin, and it rapidly achieves a maximum concentration in the blood (half-life of 45 minutes). The fast onset of action means that patients will inhale the powder at the time of meals. Insulin levels return to baseline about 3 hours after inhalation. The inhaled insulin reduces HbA\u003Csub\u003E1c\u003C\/sub\u003E by .5 to .7 mg\/dL [Neumiller JJ et al. \u003Cem\u003EAnn Pharmacother\u003C\/em\u003E 2010; Rosenstock J et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2008; Tack CJ et al. \u003Cem\u003EJ Diabetes Sci Technol\u003C\/em\u003E 2008]. Adverse events unique to insulin human inhalation powder are cough and small reductions in pulmonary function. As such, acute bronchospasm is possible if used in patients with asthma or chronic obstructive pulmonary disease. Assessment of pulmonary function is recommended at initiation, 6 months, 1 year, and then annually. Technosphere insulin is not recommended for use for smokers or for patients with active lung cancer.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EDr. Neumiller also provided an update on oral medications for the treatment of T2DM, focusing first on sodium-glucose linked transporter-2 (SGLT2) inhibitors. Glucose reabsorption is increased in T2DM primarily through increased expression and activity of SGLT2 [Bakris GL et al. \u003Cem\u003EKidney Int\u003C\/em\u003E 2009; Marsenic O et al. \u003Cem\u003EAm J Kidney Dis\u003C\/em\u003E 2009; Rahmoune H et al. \u003Cem\u003EDiabetes\u003C\/em\u003E 2005]. Inhibition of SGLT2 transporters blocks the reabsorption of filtered glucose, serving to increase glucose excretion in the urine [Idris I, Donnelly R. \u003Cem\u003EDiabetes Obes Metab\u003C\/em\u003E 2009]. When used as monotherapy, the risk for hypoglycemia with the SGLT2 inhibitors is low. Caution must be exercised when these agents are used with insulin secretagogues or insulin. Potential benefits of the agents include weight loss and a modest decrease in blood pressure.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThe newest SGLT2 inhibitor to be approved in the United States for adults with T2DM is empagliflozin. In a placebo-controlled Phase 3 trial of treatment-naive adults with T2DM, both doses of empagliflozin (10 and 25 mg) reduced levels of HbA1c more than did placebo (p \u0026lt; .001 for both). The reductions in HbA\u003Csub\u003E1c\u003C\/sub\u003E at 24 weeks were similar in magnitude to those attained with sitagliptin. Patients randomly assigned to sitagliptin had a mean increase in body weight, whereas those randomly assigned to empagliflozin experienced considerable body weight reductions [Roden M et al. \u003Cem\u003ELancet Diabetes Endocrinol\u003C\/em\u003E 2013]. When studied as an add-on to metformin plus a sulfonylurea, empagliflozin was associated with an additional reduction in HbA1c of approximately .8% in patients [H\u00e4ring HU et al. \u003Cem\u003EDiabetes Care\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EThe risk for urinary tract infections and genital fungal infections occurs more often in both women and men (mostly uncircumcised men) taking SGLT2 inhibitors compared with placebo [Stenl\u00f6f K et al. \u003Cem\u003EDiabet Obes Metab\u003C\/em\u003E 2013]. Adverse events related to osmotic diuresis-related (eg, hypovolumia) are also observed more frequently with SGLT2 inhibitors.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EEstimated glomerular filtration rate (eGFR) will decline in the first 3 to 6 weeks of therapy with an SGLT2 inhibitor. According to Dr. Neumiller, this is a hemodynamic effect of therapy rather than a toxic effect. Volume status and eGFR should be assessed before starting an SGLT2 inhibitor and periodically during treatment to ensure that patients are good candidates for this therapy. Patients with reduced eGFR may not benefit from SGLT2 inhibitors, because the drug uses renal excretion for the removal of glucose. Renal dosing is summarized in \u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15034\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15034\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15034\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-16\u0022 class=\u0022first-child\u0022\u003ERenal Dosing of SGLT2 Inhibitors\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-19\u0022\u003ESGLT2 inhibitors currently being studied in Phase 2 studies include ertugliflozin, LX4211, EGT1474, and ISIS388626, while ipragliflozin, luseogliflozin, and tofogliflozin are being studied in Phase 3 trials.\u003C\/p\u003E\u003Cp id=\u0022p-20\u0022\u003EAlbiglutide is a weekly injectable glucagon-like peptide-1 (GLP1) receptor agonist that received approval in the United States for the treatment of T2DM in April 2014. It was developed through fusion of 2 copies of a modified GLP-1 to recombinant human albumin. A single amino acid substitution renders albiglutide resistant to dipeptidyl peptidase-4 metabolism. The structure prolongs the half-life of the drug for up to 6.8 days, and steady state is reached in 3 to 4 weeks. Dosing is 30 mg weekly, which can be increased to 50 mg weekly. In a 32-week study of adults with T2DM poorly controlled on oral agents (n = 422), albiglutide 50 mg\/week did not meet a noninferiority end point on change in HbA\u003Csub\u003E1c\u003C\/sub\u003E level compared with liraglutide 1.8 mg\/day [Pratley RE et al. \u003Cem\u003ELancet Diabetes Endocrinol\u003C\/em\u003E 2014]. Thus far, treatment with albiglutide has not been shown to either increase or decrease the risk for CV events.\u003C\/p\u003E\u003Cp id=\u0022p-21\u0022\u003EDr. Triplitt concluded his presentation by noting that dulaglutide and semaglutide are GLP-1 agonists that can be administered weekly and are currently in development. An implantable GLP-1 agonist that delivers exenatide continually for 6 months is also under development.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 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\/14\/26\/21.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?nzovc1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzovc1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}