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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">diaendo</journal-id><journal-title-group><journal-title xml:lang="ru">Сахарный диабет</journal-title><trans-title-group xml:lang="en"><trans-title>Diabetes mellitus</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2072-0351</issn><issn pub-type="epub">2072-0378</issn><publisher><publisher-name>Endocrinology research centre</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.14341/DM10334</article-id><article-id custom-type="elpub" pub-id-type="custom">diaendo-10334</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Обзоры</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Review</subject></subj-group></article-categories><title-group><article-title>Особенности высококонцентрированных инсулинов: основные характеристики и результаты исследований</article-title><trans-title-group xml:lang="en"><trans-title>Special aspects of concentrated insulins: basic characteristics and research findings</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Демидова</surname><given-names>Татьяна Юльевна</given-names></name><name name-style="western" xml:lang="en"><surname>Demidova</surname><given-names>Tatiana Y.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д.м.н., профессор</p></bio><bio xml:lang="en"><p>MD, PhD, Professor</p></bio><email xlink:type="simple">t.y.demidova@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4938-1871</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Балутина</surname><given-names>Ольга Владимировна</given-names></name><name name-style="western" xml:lang="en"><surname>Balutina</surname><given-names>Olga V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>аспирант</p></bio><bio xml:lang="en"><p>MD, PhD student</p></bio><email xlink:type="simple">olgabalutina93@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Российский национальный исследовательский медицинский университет имени Н.И. Пирогова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pirogov Russian National Research Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>17</day><month>01</month><year>2020</year></pub-date><volume>22</volume><issue>5</issue><fpage>481</fpage><lpage>490</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Демидова Т.Ю., Балутина О.В., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Демидова Т.Ю., Балутина О.В.</copyright-holder><copyright-holder xml:lang="en">Demidova T.Y., Balutina O.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.dia-endojournals.ru/jour/article/view/10334">https://www.dia-endojournals.ru/jour/article/view/10334</self-uri><abstract><p>Появление в клинической практике препаратов высококонцентрированных инсулинов заставляет задуматься о преимуществах их применения у различных групп пациентов c сахарным диабетом. В данной статье мы постарались суммировать результаты последних рандомизированных исследований по эффективности и безопасности концентрированных инсулинов (в частности, инсулина лизпро 200 ЕД/мл, инсулина деглудек 200 ЕД/мл и инсулина гларгин 300 ЕД/мл) и продемонстрировать их влияние на управление сахарным диабетом на примерах из реальной клинической практики. В основном во всех исследованиях случаи тяжелой гипогликемии были достаточно редки (чаще гипогликемия регистрировалась на базис-болюсной схеме инсулинотерапии, включавшей концентрированный базальный инсулин), также статистические улучшения были отмечены и по другим критериям гипогликемии при применении инсулинов с повышенной концентрацией по сравнению с инсулином гларгин 100 Ед/мл. Во всех проанализированных исследованиях действие инсулина гларгин 300 Ед/мл было сопоставимо по своему гипогликемическому эффекту с инсулином гларгин 100 Ед/мл. Также была продемонстрирована более низкая вариабельность гликемии при применении инсулина гларгин 300 Ед/мл по сравнению с гларгином 100 Ед/мл, что делает процесс лечения еще более физиологичным и положительно влияет на прогноз развития микрососудистых осложнений диабета. Результаты рандомизированных исследований сопоставимы с опытом применения в клинической практике и указывают на эффективность и безопасность гипогликемического действия высококонцентрированных инсулинов без повышения риска развития тяжелых гипогликемических реакций.</p></abstract><trans-abstract xml:lang="en"><p>The appearance of concentrated insulins in clinical practice determines the need to analyze product priorities in appropriate groups of patients with diabetes. The aim of this article is to summarize the literature on concentrated insulins (i.e. insulin lispro 200 units/mL, insulin degludec 200 units/mL, insulin glargine 300 units/mL) from randomized controlled trials, derive guidance on appropriate and safe use of these agents and demonstrate experience in real clinical practice. Severe hypoglycemia in all studies was generally low (though higher with prandial plus concentrated basal analogue therapy), and statistical improvements in other hypoglycemia categories were observed for concentrated basal insulins versus insulin glargine 100 units/mL. In all analyzed data hypoglycemic effect of insulin glargine 300 units/mL was equitable to insulin glargine 100 units/mL. Other important findings demonstrate more constant and prolonged insulin action with low within-subject/ between-day variability for insulin glargine 300 units/mL versus insulin glargine 100 units/mL, therefore, more physiological treatment might prevent from diabetic microvascular complications. The results of randomized trials are comparable with our clinical practice experience and indicate efficacious and safe glucose-lowering properties without risk of severe hypoglycemia.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>концентрированные инсулины</kwd><kwd>сахарный диабет</kwd><kwd>эугликемические клэмп-исследования</kwd><kwd>снижение риска гипогликемии</kwd></kwd-group><kwd-group xml:lang="en"><kwd>concentrated insulin</kwd><kwd>diabetes mellitus</kwd><kwd>euglycemic clamp</kwd><kwd>reduce risk of hypoglycemia</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Bliss M. The Discovery of insulin. Chicago: The University of Chicago Press; 1982.</mixed-citation><mixed-citation xml:lang="en">Bliss M. The Discovery of insulin. Chicago: The University of Chicago Press; 1982.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Sneader W. Drug discovery: a history. Chichester, England: John Wiley and Sons Ltd; 2005. 472 р.</mixed-citation><mixed-citation xml:lang="en">Sneader W. Drug discovery: a history. Chichester, England: John Wiley and Sons Ltd; 2005. 472 р.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Meneghini L. New insulin preparations: a primer for the clinician. Cleve Clin J Med. 2016;83(5 Suppl 1):S27−33. doi: https://doi.org/10.3949/ccjm.83.s1.05</mixed-citation><mixed-citation xml:lang="en">Meneghini L. New insulin preparations: a primer for the clinician. Cleve Clin J Med. 2016;83(5 Suppl 1):S27−33. doi: https://doi.org/10.3949/ccjm.83.s1.05</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Barnosky A, Shah L, Meah F, et al. A primer on concentrated insulins: what an internist should know. Postgrad Med. 2016;128(4):381−390. doi: https://doi.org/10.1080/00325481.2016.1159909</mixed-citation><mixed-citation xml:lang="en">Barnosky A, Shah L, Meah F, et al. A primer on concentrated insulins: what an internist should know. Postgrad Med. 2016;128(4):381−390. doi: https://doi.org/10.1080/00325481.2016.1159909</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Lamos EM, Younk LM, Davis SN. Concentrated insulins: the new basal insulins. Ther Clin Risk Manag. 2016;12:389−400. doi: https://doi.org/10.2147/TCRM.S99855</mixed-citation><mixed-citation xml:lang="en">Lamos EM, Younk LM, Davis SN. Concentrated insulins: the new basal insulins. Ther Clin Risk Manag. 2016;12:389−400. doi: https://doi.org/10.2147/TCRM.S99855</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Painter NA, Sisson E. An overview of concentrated insulin products. Diabetes Spectr. 2016;29(3):136−140. doi: https://doi.org/10.2337/diaspect.29.3.136</mixed-citation><mixed-citation xml:lang="en">Painter NA, Sisson E. An overview of concentrated insulin products. Diabetes Spectr. 2016;29(3):136−140. doi: https://doi.org/10.2337/diaspect.29.3.136</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Segal AR, Vootla T, Beaser RS. Insulin: making sense of current options. Endocrinol Metab Clin North Am. 2016;45(4):845−874. doi: https://doi.org/10.1016/j.ecl.2016.06.009</mixed-citation><mixed-citation xml:lang="en">Segal AR, Vootla T, Beaser RS. Insulin: making sense of current options. Endocrinol Metab Clin North Am. 2016;45(4):845−874. doi: https://doi.org/10.1016/j.ecl.2016.06.009</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">de la Peña A, Seger M, Soon D, et al. Bioequivalence and comparative pharmacodynamics of insulin lispro 200 U/mL relative to insulin lispro (Humalog) 100 U/mL. Clin Pharmacol Drug Dev. 2016;5(1):69−75. doi: https://doi.org/10.1002/cpdd.221</mixed-citation><mixed-citation xml:lang="en">de la Peña A, Seger M, Soon D, et al. Bioequivalence and comparative pharmacodynamics of insulin lispro 200 U/mL relative to insulin lispro (Humalog) 100 U/mL. Clin Pharmacol Drug Dev. 2016;5(1):69−75. doi: https://doi.org/10.1002/cpdd.221</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Simpson D, McCormack PL, Keating GM, Lyseng-Williamson KA. Insulin lispro: a review of its use in the management of diabetes mellitus. Drugs. 2007;67(3):407−434. doi: https://doi.org/10.2165/00003495-200767030-00006</mixed-citation><mixed-citation xml:lang="en">Simpson D, McCormack PL, Keating GM, Lyseng-Williamson KA. Insulin lispro: a review of its use in the management of diabetes mellitus. Drugs. 2007;67(3):407−434. doi: https://doi.org/10.2165/00003495-200767030-00006</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Heise T, Nosek L, Hovelmann U, et al. Insulin degludec 200 U/ml is ultra-long-acting and has a flat and stable glucose-lowering effect. Canadian J Diabet. 2012;36(5):S13. doi: https://doi.org/10.1016/j.jcjd.2012.07.058</mixed-citation><mixed-citation xml:lang="en">Heise T, Nosek L, Hovelmann U, et al. Insulin degludec 200 U/ml is ultra-long-acting and has a flat and stable glucose-lowering effect. Canadian J Diabet. 2012;36(5):S13. doi: https://doi.org/10.1016/j.jcjd.2012.07.058</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Korsatko S, Deller S, Koehler G, et al. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013;33(7):515−521. doi: https://doi.org/10.1007/s40261-013-0096-7</mixed-citation><mixed-citation xml:lang="en">Korsatko S, Deller S, Koehler G, et al. A comparison of the steady-state pharmacokinetic and pharmacodynamic profiles of 100 and 200 U/mL formulations of ultra-long-acting insulin degludec. Clin Drug Investig. 2013;33(7):515−521. doi: https://doi.org/10.1007/s40261-013-0096-7</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Bode BW, Chaykin LB, Sussman AM, et al. Efficacy and safety of insulin degludec 200 U/mL and insulin degludec 100 U/mL in patients with type 2 diabetes (begin: compare). Endocr Pract. 2014;20(8):785−791. doi: https://doi.org/10.4158/EP13411.OR</mixed-citation><mixed-citation xml:lang="en">Bode BW, Chaykin LB, Sussman AM, et al. Efficacy and safety of insulin degludec 200 U/mL and insulin degludec 100 U/mL in patients with type 2 diabetes (begin: compare). Endocr Pract. 2014;20(8):785−791. doi: https://doi.org/10.4158/EP13411.OR</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Gough SC, Bhargava A, Jain R, et al. Low-volume insulin degludec 200 units/mL once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013;36(9):2536−2542. doi: https://doi.org/10.2337/dc12-2329</mixed-citation><mixed-citation xml:lang="en">Gough SC, Bhargava A, Jain R, et al. Low-volume insulin degludec 200 units/mL once daily improves glycemic control similarly to insulin glargine with a low risk of hypoglycemia in insulin-naive patients with type 2 diabetes: a 26-week, randomized, controlled, multinational, treat-to-target trial: the BEGIN LOW VOLUME trial. Diabetes Care. 2013;36(9):2536−2542. doi: https://doi.org/10.2337/dc12-2329</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Zinman B, DeVries JH, Bode B, et al. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013;1(2):123−131. doi: https://doi.org/10.1016/S2213-8587(13)70013-5</mixed-citation><mixed-citation xml:lang="en">Zinman B, DeVries JH, Bode B, et al. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013;1(2):123−131. doi: https://doi.org/10.1016/S2213-8587(13)70013-5</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Warren M, Chaykin L, Jabbour S, et al. Insulin degludec 200 units/ml is associated with lower injection frequency and improved patient-reported outcomes compared with insulin glargine 100 units/ml in patients with type 2 diabetes requiring high-dose insulin. Clin Diabetes. 2017;35(2):90−95. doi: https://doi.org/10.2337/cd15-0058</mixed-citation><mixed-citation xml:lang="en">Warren M, Chaykin L, Jabbour S, et al. Insulin degludec 200 units/ml is associated with lower injection frequency and improved patient-reported outcomes compared with insulin glargine 100 units/ml in patients with type 2 diabetes requiring high-dose insulin. Clin Diabetes. 2017;35(2):90−95. doi: https://doi.org/10.2337/cd15-0058</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Becker RH, Dahmen R, Bergmann K, et al. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015;38(4):637−643. doi: https://doi.org/10.2337/dc14-0006</mixed-citation><mixed-citation xml:lang="en">Becker RH, Dahmen R, Bergmann K, et al. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015;38(4):637−643. doi: https://doi.org/10.2337/dc14-0006</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Shiramoto M, Eto T, Irie S, et al. Single-dose new insulin glargine 300 U/mL provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes Metab. 2015;17(3):254−260. doi: https://doi.org/10.1111/dom.12415</mixed-citation><mixed-citation xml:lang="en">Shiramoto M, Eto T, Irie S, et al. Single-dose new insulin glargine 300 U/mL provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes Metab. 2015;17(3):254−260. doi: https://doi.org/10.1111/dom.12415</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Becker RH, Nowotny I, Teichert L, et al. Low within- and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes Metab. 2015;17(3):261−267. doi: https://doi.org/10.1111/dom.12416</mixed-citation><mixed-citation xml:lang="en">Becker RH, Nowotny I, Teichert L, et al. Low within- and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes Metab. 2015;17(3):261−267. doi: https://doi.org/10.1111/dom.12416</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Jinnouchi H, Koyama M, Amano A, et al. Continuous glucose monitoring during basal-bolus therapy using insulin glargine 300 U mL-1 and glargine 100 U mL-1 in Japanese people with type 1 diabetes mellitus: a crossover pilot study. Diabetes Ther. 2015;6(2):143−152. doi: https://doi.org/10.1007/s13300-015-0115-1</mixed-citation><mixed-citation xml:lang="en">Jinnouchi H, Koyama M, Amano A, et al. Continuous glucose monitoring during basal-bolus therapy using insulin glargine 300 U mL-1 and glargine 100 U mL-1 in Japanese people with type 1 diabetes mellitus: a crossover pilot study. Diabetes Ther. 2015;6(2):143−152. doi: https://doi.org/10.1007/s13300-015-0115-1</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Steinstraesser A, Schmidt R, Bergmann K, et al. Investigational new insulin glargine 300 U/mL has the same metabolism as insulin glargine 100 U/mL. Diabetes Obes Metab. 2014;16(9):873−876. doi: https://doi.org/10.1111/dom.12283</mixed-citation><mixed-citation xml:lang="en">Steinstraesser A, Schmidt R, Bergmann K, et al. Investigational new insulin glargine 300 U/mL has the same metabolism as insulin glargine 100 U/mL. Diabetes Obes Metab. 2014;16(9):873−876. doi: https://doi.org/10.1111/dom.12283</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Государственный реестр лекарственных средств. Сведения из ГРЛС о лекарственных средствах с рег. № ЛП-003653. Инструкция по применению лекарственного препарата для медицинского применения Туджео СолоСтар. [Gosudarstvennyy reyestr lekarstvennykh sredstv. Svedeniya iz GRLS o lekarstvennykh sredstvakh s reg. № LP-003653. Instruktsiya po primeneniyu lekarstvennogo preparata dlya meditsinskogo primeneniya Tudzheo SoloStar. (In Russ).] Доступно по: https://zdravmedinform.ru/grls/reg-lp-003653.html. Ссылка активна на 15.07.2019.</mixed-citation><mixed-citation xml:lang="en">Государственный реестр лекарственных средств. Сведения из ГРЛС о лекарственных средствах с рег. № ЛП-003653. Инструкция по применению лекарственного препарата для медицинского применения Туджео СолоСтар. [Gosudarstvennyy reyestr lekarstvennykh sredstv. Svedeniya iz GRLS o lekarstvennykh sredstvakh s reg. № LP-003653. Instruktsiya po primeneniyu lekarstvennogo preparata dlya meditsinskogo primeneniya Tudzheo SoloStar. (In Russ).] Доступно по: https://zdravmedinform.ru/grls/reg-lp-003653.html. Ссылка активна на 15.07.2019.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Matsuhisa M, Koyama M, Cheng X, et al. New insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016;18(4):375−383. doi: https://doi.org/10.1111/dom.12619</mixed-citation><mixed-citation xml:lang="en">Matsuhisa M, Koyama M, Cheng X, et al. New insulin glargine 300 U/mL versus glargine 100 U/mL in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016;18(4):375−383. doi: https://doi.org/10.1111/dom.12619</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Matsuhisa M, Koyama M, Cheng X, et al. Sustained glycaemic control and less nocturnal hypoglycemia with insulin glargine 300U/mL compared with glargine 100U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12-month trial including 6-month extension). Diabetes Res Clin Pract. 2016;122:133−140. doi: https://doi.org/10.1016/j.diabres.2016.10.002</mixed-citation><mixed-citation xml:lang="en">Matsuhisa M, Koyama M, Cheng X, et al. Sustained glycaemic control and less nocturnal hypoglycemia with insulin glargine 300U/mL compared with glargine 100U/mL in Japanese adults with type 1 diabetes (EDITION JP 1 randomised 12-month trial including 6-month extension). Diabetes Res Clin Pract. 2016;122:133−140. doi: https://doi.org/10.1016/j.diabres.2016.10.002</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37(10):2755−2762. doi: https://doi.org/10.2337/dc14-0991</mixed-citation><mixed-citation xml:lang="en">Riddle MC, Bolli GB, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37(10):2755−2762. doi: https://doi.org/10.2337/dc14-0991</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Yki-Järvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014;37(12):3235−3243. doi: https://doi.org/10.2337/dc14-0990</mixed-citation><mixed-citation xml:lang="en">Yki-Järvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014;37(12):3235−3243. doi: https://doi.org/10.2337/dc14-0990</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Bolli GB, Riddle MC, Bergenstal RM, et al. New insulin glargine 300 U/mL compared with glargine 100 U/mL in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386−394. doi: https://doi.org/10.1111/dom.12438</mixed-citation><mixed-citation xml:lang="en">Bolli GB, Riddle MC, Bergenstal RM, et al. New insulin glargine 300 U/mL compared with glargine 100 U/mL in insulin-naive people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386−394. doi: https://doi.org/10.1111/dom.12438</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Riddle MC, Yki-Jarvinen H, Bolli GB, et al. One-year sustained glycaemic control and less hypoglycemia with new insulin glargine 300 U/mL compared with 100 U/mL in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes Metab. 2015;17(9):835−842. doi: https://doi.org/10.1111/dom.12472</mixed-citation><mixed-citation xml:lang="en">Riddle MC, Yki-Jarvinen H, Bolli GB, et al. One-year sustained glycaemic control and less hypoglycemia with new insulin glargine 300 U/mL compared with 100 U/mL in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes Metab. 2015;17(9):835−842. doi: https://doi.org/10.1111/dom.12472</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">Yki-Jarvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/mL versus insulin glargine 100 U/mL in people with type 2 diabetes using basal insulin and oral antihyperglycemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015;17(12):1142−1149. doi: https://doi.org/10.1111/dom.12532</mixed-citation><mixed-citation xml:lang="en">Yki-Jarvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/mL versus insulin glargine 100 U/mL in people with type 2 diabetes using basal insulin and oral antihyperglycemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015;17(12):1142−1149. doi: https://doi.org/10.1111/dom.12532</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">Terauchi Y, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016;18(4):366−374. doi: https://doi.org/10.1111/dom.12618</mixed-citation><mixed-citation xml:lang="en">Terauchi Y, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016;18(4):366−374. doi: https://doi.org/10.1111/dom.12618</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2015;38(12):2217−2225. doi: https://doi.org/10.2337/dc15-0249</mixed-citation><mixed-citation xml:lang="en">Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2015;38(12):2217−2225. doi: https://doi.org/10.2337/dc15-0249</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">Twigg SM, Escalada J, Stella P, et al. Association of patient profile with glycemic control and hypoglycemia with insulin glargine 300 U/mL in type 2 diabetes: a post hoc patient-level meta-analysis. Diabetes Ther. 2018;9(5):2043−2053. doi: https://doi.org/10.1007/s13300-018-0498-x</mixed-citation><mixed-citation xml:lang="en">Twigg SM, Escalada J, Stella P, et al. Association of patient profile with glycemic control and hypoglycemia with insulin glargine 300 U/mL in type 2 diabetes: a post hoc patient-level meta-analysis. Diabetes Ther. 2018;9(5):2043−2053. doi: https://doi.org/10.1007/s13300-018-0498-x</mixed-citation></citation-alternatives></ref><ref id="cit32"><label>32</label><citation-alternatives><mixed-citation xml:lang="ru">Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 Units/mL versus insulin degludec 100 Units/mL in insulin-naive type 2 diabetes: the randomized head-to-head BRIGHT trial. Diabetes Care. 2018;41(10):2147−2154. doi: https://doi.org/10.2337/dc18-0559</mixed-citation><mixed-citation xml:lang="en">Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 Units/mL versus insulin degludec 100 Units/mL in insulin-naive type 2 diabetes: the randomized head-to-head BRIGHT trial. Diabetes Care. 2018;41(10):2147−2154. doi: https://doi.org/10.2337/dc18-0559</mixed-citation></citation-alternatives></ref><ref id="cit33"><label>33</label><citation-alternatives><mixed-citation xml:lang="ru">Ovalle F, Segal AR, Anderson JE, et al. Understanding concentrated insulins: a systematic review of randomized controlled trials. Curr Med Res Opin. 2018;34(6):1029−1043. doi: https://doi.org/10.1080/03007995.2017.1409426</mixed-citation><mixed-citation xml:lang="en">Ovalle F, Segal AR, Anderson JE, et al. Understanding concentrated insulins: a systematic review of randomized controlled trials. Curr Med Res Opin. 2018;34(6):1029−1043. doi: https://doi.org/10.1080/03007995.2017.1409426</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
