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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">medsovet</journal-id><journal-title-group><journal-title xml:lang="ru">Медицинский Совет</journal-title><trans-title-group xml:lang="en"><trans-title>Meditsinskiy sovet = Medical Council</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2079-701X</issn><issn pub-type="epub">2658-5790</issn><publisher><publisher-name>REMEDIUM GROUP Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21518/2079-701X-2021-12-246-255</article-id><article-id custom-type="elpub" pub-id-type="custom">medsovet-6355</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>ЭНДОКРИНОЛОГИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ENDOCRINOLOGY</subject></subj-group></article-categories><title-group><article-title>Аналог инсулина длительного действия в терапии сахарного диабета 2-го типа: акцент на доказанную эффективность и безопасность</article-title><trans-title-group xml:lang="en"><trans-title>Long-acting insulin analogue in the treatment of type 2 diabetes mellitus: emphasis on proven efficacy and safety</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>Бирюкова</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Biryukova</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д.м.н., профессор кафедры эндокринологии и  диабетологии, </p><p>127473, Москва, ул. Делегатская, д. 20, стр. 1</p></bio><bio xml:lang="en"><p>Dr. Sci. (Med.), Professor of  the  Department of  Endocrinology and Diabetology, </p><p>20, Bldg. 1, Delegatskaya St., Moscow, 127473</p></bio><email xlink:type="simple">lena@obsudim.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шинкин</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shinkin</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>научный сотрудник отдела эндокринных и метаболических нарушений, врач эндокринолог отделения диагностики и общей терапии, </p><p>111123, Москва, шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p>Researcher, Department of Endocrine and Metabolic Disorders, Endocrinologist, Department of Diagnostics and General Therapy, </p><p>20, Bldg. 1, Delegatskaya St., Moscow, 127473</p></bio><email xlink:type="simple">jendis@ya.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Михеева</surname><given-names>О. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Mikheeva</surname><given-names>O. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д.м.н., профессор, заведующая отделением диагностики и общей терапии,</p><p>111123, Москва, шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p>Dr. Sci. (Med.), Professor, Head of the Department of Diagnostics and General Therapy, </p><p>20, Bldg. 1, Delegatskaya St., Moscow, 127473</p></bio><email xlink:type="simple">ol.miheeva@mknc.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Московский государственный медикостоматологический университет имени А.И. Евдокимова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Yevdokimov Moscow State University of Medicine and Dentistry</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Московский клинический научный центр имени А.С. Логинова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Yevdokimov Moscow State University of Medicine and Dentistry</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>18</day><month>09</month><year>2021</year></pub-date><volume>0</volume><issue>12</issue><fpage>246</fpage><lpage>255</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Бирюкова Е.В., Шинкин М.В., Михеева О.М., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Бирюкова Е.В., Шинкин М.В., Михеева О.М.</copyright-holder><copyright-holder xml:lang="en">Biryukova E.V., Shinkin M.V., Mikheeva O.M.</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.med-sovet.pro/jour/article/view/6355">https://www.med-sovet.pro/jour/article/view/6355</self-uri><abstract><p>Со временем для достижения и поддержания целевых показателей гликемии назначение инсулинотерапии (ИТ) становится неизбежным для многих пациентов с сахарным диабетом (СД) 2-го типа. Согласно действующим рекомендациям добавление базального инсулина к сахароснижающей терапии при недостаточном контроле СД 2-го типа, постепенное титрование его дозы в соответствии с уровнем глюкозы крови натощак являются эффективным и безопасным методом инициирования ИТ. Рассматриваются свойства современных аналогов инсулина длительного действия. Гларгин 300 ЕД/мл – современный аналог инсулина длительного действия, предназначенный для введения один раз в сутки, основу которого составляет молекула гларгина. Увеличение концентрации гларгина в единице объема с формированием подкожного депо меньшей площади привело к изменению фармакокинетических свойств препарата. Гларгин 300 МЕ/мл по сравнению с гларгином 100 МЕ/мл обеспечивает более стабильное, продолжительное, предсказуемое действие с низкой вариабельностью гликемии, что снижает риск развития гипогликемии. Обсуждаются сахароснижающая эффективность и безопасность инсулина гларгина 300 ЕД/мл по данным программы международных клинических исследований III фазы EDITION. Инсулин гларгин 300 ЕД/мл показал сходное снижение уровней HbA1c по сравнению с инсулином гларгином 100 ЕД/мл с улучшенным профилем безопасности (более низким риском развития эпизодов подтвержденных или тяжелых гипогликемий в любое время суток, в т. ч. в ночное время) и менее выраженным влиянием на массу тела пациентов с СД 2-го типа. Эффективность и безопасность применения гларгина 300 ЕД/мл подтверждена у пациентов с СД 2-го типа с хронической болезнью почек и пожилого возраста. В исследовании BRIGHT гларгин 300 ЕД/мл продемонстрировал сопоставимый гликемический контроль в сравнении с инсулином деглудеком и более благоприятный профиль безопасности в течение первых 12 нед. Приведены результаты исследований TAKE CONTROL и ORION. </p></abstract><trans-abstract xml:lang="en"><p>In time, prescription of insulin therapy (IT) becomes inevitable for many patients with type 2 diabetes mellitus (DM) to achieve and maintain the target hypoglycemic range.</p><p>According to the current guidelines, the addition of basal insulin to glucose-lowering therapy in patients with insufficient control of type 2 diabetes, gradual titration of its dose in accordance with a fasting blood glucose level is an effective and safe method for initiating IT. The properties of modern long-acting insulin analogues are considered. Glargine 300 U/ml is a modern analogue of long-acting insulin that is intended to be used once a day. The glargine molecule forms the basis of the drug. Increasing the concentration of glargine per volume unit and formation of a smaller subcutaneous depot led to a change in the pharmacokinetic properties of the drug. Glargine 300 IU/ml provides a more stable, long-term, predictable action with low glycemic variability as compared with glargine 100 IU/ml, which reduces the risk of hypoglycemia. The sugar-reducing efficacy and safety of insulin glargine 300 U/ml as evidenced by the findings of the international clinical phase III EDITION studies are discussed. Insulin glargine 300 U/ml showed a similar decrease in HbA1c levels compared to insulin glargine 100 U/ml with an improved safety profile (lower risk of developing episodes of confirmed or severe hypoglycemia at all times of the day, including the nighttime) and a less pronounced effect on the body weight of patients with type 2 diabetes. The efficacy and safety of the use of glargine 300 U/ml has been confirmed in type 2 diabetes patients with chronic kidney disease and the elderly. In the BRIGHT study, glargine 300 U/ml showed comparable glycemic control when it is being compared. </p></trans-abstract><kwd-group xml:lang="ru"><kwd>HbA1c</kwd><kwd>интенсификация сахароснижающей терапии</kwd><kwd>аналоги инсулина</kwd><kwd>гипогликемия</kwd><kwd>гларгин 300 ЕД/мл</kwd></kwd-group><kwd-group xml:lang="en"><kwd>HbA1c</kwd><kwd>intensification of hypoglycemic therapy</kwd><kwd>insulin analogues</kwd><kwd>hypoglycemia</kwd><kwd>glargine 300 U/ml</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">Chen L., Magliano D.J., Zimmet P.Z. The Worldwide Epidemiology of Type 2 Diabetes Mellitus – Present and Future Perspectives. Nat Rev Endocrinol. 2011;8(4):228–236. https://doi.org/10.1038/nrendo.2011.183.</mixed-citation><mixed-citation xml:lang="en">Chen L., Magliano D.J., Zimmet P.Z. The Worldwide Epidemiology of Type 2 Diabetes Mellitus – Present and Future Perspectives. Nat Rev Endocrinol. 2011;8(4):228–236. https://doi.org/10.1038/nrendo.2011.183.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Hanefeld M., Monnier L., Schnell O., Owens D. Early Treatment with Basal Insulin Glargine in People with Type 2 Diabetes: Lessons from ORIGIn and Other Cardiovascular Trials. Diabetes Ther. 2016;7(2):187–201. https://doi.org/10.1007/s13300-016-0153-3.</mixed-citation><mixed-citation xml:lang="en">Hanefeld M., Monnier L., Schnell O., Owens D. Early Treatment with Basal Insulin Glargine in People with Type 2 Diabetes: Lessons from ORIGIn and Other Cardiovascular Trials. Diabetes Ther. 2016;7(2):187–201. https://doi.org/10.1007/s13300-016-0153-3.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Wajchenberg BL. Beta-Cell Failure in Diabetes and Preservation by Clinical Treatment. Endocr Rev. 2007;28(2):187–218. https://doi.org/10.1210/10.1210/er.2006-0038.</mixed-citation><mixed-citation xml:lang="en">Wajchenberg BL. Beta-Cell Failure in Diabetes and Preservation by Clinical Treatment. Endocr Rev. 2007;28(2):187–218. https://doi.org/10.1210/10.1210/er.2006-0038.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Bagust A., Beale S. Deteriorating Beta-Cell Function in Type 2 Diabetes: A Long-Term Model. QJM. 2003;96(4):281–288. https://doi.org/10.1093/qjmed/hcg040.</mixed-citation><mixed-citation xml:lang="en">Bagust A., Beale S. Deteriorating Beta-Cell Function in Type 2 Diabetes: A Long-Term Model. QJM. 2003;96(4):281–288. https://doi.org/10.1093/qjmed/hcg040.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Heine R.J., Diamant M., Mbanya J.C., Nathan D.M. Management of Hyperglycaemia in Type 2 Diabetes: the End of Recurrent Failure? BMJ. 2006;333(7580):1200–1204. https://doi.org/10.1136/bmj.39022.462546.80.</mixed-citation><mixed-citation xml:lang="en">Heine R.J., Diamant M., Mbanya J.C., Nathan D.M. Management of Hyperglycaemia in Type 2 Diabetes: the End of Recurrent Failure? BMJ. 2006;333(7580):1200–1204. https://doi.org/10.1136/bmj.39022.462546.80.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Hanefeld M., Fleischmann H., Siegmund T., Seufert J. Rationale for Timely Insulin Therapy in Type 2 Diabetes within the Framework of Individualised Treatment: 2020 Update. Diabetes Ther. 2020;11(8):1645–1666. https://doi.org/10.1007/s13300-020-00855-5.</mixed-citation><mixed-citation xml:lang="en">Hanefeld M., Fleischmann H., Siegmund T., Seufert J. Rationale for Timely Insulin Therapy in Type 2 Diabetes within the Framework of Individualised Treatment: 2020 Update. Diabetes Ther. 2020;11(8):1645–1666. https://doi.org/10.1007/s13300-020-00855-5.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Дедов И.И., Шестакова М.В., Майоров А.Ю. (ред.) Алгоритмы специализированной медицинской помощи больным сахарным диабетом. 9-й вып. Сахарный диабет. 2019;22(1S1):1–144. https://doi.org/10.14341/DM221S1.</mixed-citation><mixed-citation xml:lang="en">Dedov I.I., Shestakova M.V., Mayorov A.Yu. (eds.). Algorithms for Specialized Medical Care for Patients with Diabetes Mellitus. 9th ed. Sakharnyy diabet = Diabetes Mellitus. 2019;22(1S1):1–144. (In Russ.) https://doi.org/10.14341/DM221S1.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Introduction: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S1–S2. https://doi.org/10.2337/dc20-Sint.</mixed-citation><mixed-citation xml:lang="en">Introduction: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S1–S2. https://doi.org/10.2337/dc20-Sint.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Fonseca V., Gill J., Zhou R., Leahy J. An Analysis of Early Insulin Glargine Added to Metformin with or without Sulfonylurea: Impact on Glycaemic Control and Hypoglycaemia. Diabetes Obes Metab. 2011;13(9):814–822. https://doi.org/10.1111/j.1463-1326.2011.01412.x.</mixed-citation><mixed-citation xml:lang="en">Fonseca V., Gill J., Zhou R., Leahy J. An Analysis of Early Insulin Glargine Added to Metformin with or without Sulfonylurea: Impact on Glycaemic Control and Hypoglycaemia. Diabetes Obes Metab. 2011;13(9):814–822. https://doi.org/10.1111/j.1463-1326.2011.01412.x.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Seufert J., Fritsche A., Pscherer S., Anderten H., Borck A., Pegelow K. et al. Titration and Optimization Trial for the Initiation of Insulin Glargine 100 U/mL in Patients with Inadequately Controlled Type 2 Diabetes on Oral Antidiabetic Drugs. Diabetes Obes Metab. 2019;21(2):439–443. https://doi.org/10.1111/dom.13535.</mixed-citation><mixed-citation xml:lang="en">Seufert J., Fritsche A., Pscherer S., Anderten H., Borck A., Pegelow K. et al. Titration and Optimization Trial for the Initiation of Insulin Glargine 100 U/mL in Patients with Inadequately Controlled Type 2 Diabetes on Oral Antidiabetic Drugs. Diabetes Obes Metab. 2019;21(2):439–443. https://doi.org/10.1111/dom.13535.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Blonde L., Aschner P., Bailey C., Ji L., Leiter L.A., Matthaei S. Gaps and Barriers in the Control of Blood Glucose in People with Type 2 Diabetes. Diab Vasc Dis Res. 2017;14(3):172–183. https://doi.org/10.1177/1479164116679775.</mixed-citation><mixed-citation xml:lang="en">Blonde L., Aschner P., Bailey C., Ji L., Leiter L.A., Matthaei S. Gaps and Barriers in the Control of Blood Glucose in People with Type 2 Diabetes. Diab Vasc Dis Res. 2017;14(3):172–183. https://doi.org/10.1177/1479164116679775.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Karam S.L., Dendy J., Polu S., Blonde L. Overview of Therapeutic Inertia in Diabetes: Prevalence, Causes, and Consequences. Diabetes Spectr. 2020;33(1):8–15. https://doi.org/10.2337/ds19-0029.</mixed-citation><mixed-citation xml:lang="en">Karam S.L., Dendy J., Polu S., Blonde L. Overview of Therapeutic Inertia in Diabetes: Prevalence, Causes, and Consequences. Diabetes Spectr. 2020;33(1):8–15. https://doi.org/10.2337/ds19-0029.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Khan H., Lasker S.S., Chowdhury T.A. Exploring Reasons for Very Poor Glycaemic Control in Patients with Type 2 Diabetes. Prim Care Diabetes. 2011;5(4):251–255. https://doi.org/10.1016/j.pcd.2011.07.001.</mixed-citation><mixed-citation xml:lang="en">Khan H., Lasker S.S., Chowdhury T.A. Exploring Reasons for Very Poor Glycaemic Control in Patients with Type 2 Diabetes. Prim Care Diabetes. 2011;5(4):251–255. https://doi.org/10.1016/j.pcd.2011.07.001.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Mauricio D., Meneghini L., Seufert J., Liao L., Wang H., Tong L. et al. Glycaemic Control and Hypoglycaemia Burden in Patients with Type 2 Diabetes Initiating Basal Insulin in Europe and the USA. Diabetes Obes Metab. 2017;19(8):1155–1164. https://doi.org/10.1111/dom.12927.</mixed-citation><mixed-citation xml:lang="en">Mauricio D., Meneghini L., Seufert J., Liao L., Wang H., Tong L. et al. Glycaemic Control and Hypoglycaemia Burden in Patients with Type 2 Diabetes Initiating Basal Insulin in Europe and the USA. Diabetes Obes Metab. 2017;19(8):1155–1164. https://doi.org/10.1111/dom.12927.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Khunti K., Millar-Jones D. Clinical Inertia to Insulin Initiation and Intensification in the UK: A Focused Literature Review. Prim Care Diabetes. 2017;11(1):3–12. https://doi.org/10.1016/j.pcd.2016.09.003.</mixed-citation><mixed-citation xml:lang="en">Khunti K., Millar-Jones D. Clinical Inertia to Insulin Initiation and Intensification in the UK: A Focused Literature Review. Prim Care Diabetes. 2017;11(1):3–12. https://doi.org/10.1016/j.pcd.2016.09.003.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Lovre D., Fonseca V. Benefits of Timely Basal Insulin Control in Patients with Type 2 Diabetes. J Diabetes Complications. 2015;29(2):295–301. https://doi.org/10.1016/j.jdiacomp.2014.11.018.</mixed-citation><mixed-citation xml:lang="en">Lovre D., Fonseca V. Benefits of Timely Basal Insulin Control in Patients with Type 2 Diabetes. J Diabetes Complications. 2015;29(2):295–301. https://doi.org/10.1016/j.jdiacomp.2014.11.018.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Khunti K., Wolden M.L., Thorsted B.L., Andersen M., Davies M.J. Clinical Inertia in People with Type 2 Diabetes: A Retrospective Cohort Study of More Than 80,000 People. Diabetes Care. 2013;36(11):3411–3417. https://doi.org/10.2337/dc13-0331.</mixed-citation><mixed-citation xml:lang="en">Khunti K., Wolden M.L., Thorsted B.L., Andersen M., Davies M.J. Clinical Inertia in People with Type 2 Diabetes: A Retrospective Cohort Study of More Than 80,000 People. Diabetes Care. 2013;36(11):3411–3417. https://doi.org/10.2337/dc13-0331.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Paul S.K., Klein K., Thorsted B.L., Wolden M.L., Khunti K. Delay in Treatment Intensification Increases the Risks of Cardiovascular Events in Patients with Type 2 Diabetes. Cardiovasc Diabetol. 2015;14:100. https://doi.org/10.1186/s12933-015-0260-x.</mixed-citation><mixed-citation xml:lang="en">Paul S.K., Klein K., Thorsted B.L., Wolden M.L., Khunti K. Delay in Treatment Intensification Increases the Risks of Cardiovascular Events in Patients with Type 2 Diabetes. Cardiovasc Diabetol. 2015;14:100. https://doi.org/10.1186/s12933-015-0260-x.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Owens D.R., Matfin G., Monnier L. Basal Insulin Analogues in the Management of Diabetes Mellitus: What Progress Have We Made? Diabetes Metab Res Rev. 2014;30(2):104–119. https://doi.org/10.1002/dmrr.2469.</mixed-citation><mixed-citation xml:lang="en">Owens D.R., Matfin G., Monnier L. Basal Insulin Analogues in the Management of Diabetes Mellitus: What Progress Have We Made? Diabetes Metab Res Rev. 2014;30(2):104–119. https://doi.org/10.1002/dmrr.2469.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Brown A., Guess N., Dornhorst A., Taheri S., Frost G. Insulin-Associated Weight Gain in Obese Type 2 Diabetes Mellitus Patients: What Can Be Done? Diabetes Obes Metab. 2017;19(12):1655–1668. https://doi.org/10.1111/dom.13009.</mixed-citation><mixed-citation xml:lang="en">Brown A., Guess N., Dornhorst A., Taheri S., Frost G. Insulin-Associated Weight Gain in Obese Type 2 Diabetes Mellitus Patients: What Can Be Done? Diabetes Obes Metab. 2017;19(12):1655–1668. https://doi.org/10.1111/dom.13009.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Zhou Z., Sun B., Huang S., Zhu C., Bian M. Glycemic Variability: Adverse Clinical Outcomes and How to Improve It? Cardiovasc Diabetol. 2020;19(1):102. https://doi.org/10.1186/s12933-020-01085-6.</mixed-citation><mixed-citation xml:lang="en">Zhou Z., Sun B., Huang S., Zhu C., Bian M. Glycemic Variability: Adverse Clinical Outcomes and How to Improve It? Cardiovasc Diabetol. 2020;19(1):102. https://doi.org/10.1186/s12933-020-01085-6.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Vora J., Heise T. Variability of Glucose-Lowering Effect as a Limiting Factor in Optimizing Basal Insulin Therapy: A Review. Diabetes Obes Metab. 2013;15(8):701–712. https://doi.org/10.1111/dom.12087.</mixed-citation><mixed-citation xml:lang="en">Vora J., Heise T. Variability of Glucose-Lowering Effect as a Limiting Factor in Optimizing Basal Insulin Therapy: A Review. Diabetes Obes Metab. 2013;15(8):701–712. https://doi.org/10.1111/dom.12087.</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Umpierrez G.E., Kovatchev B.P. Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes. Am J Med Sci. 2018;356(6):518–527. https://doi.org/10.1016/j.amjms.2018.09.010.</mixed-citation><mixed-citation xml:lang="en">Umpierrez G.E., Kovatchev B.P. Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes. Am J Med Sci. 2018;356(6):518–527. https://doi.org/10.1016/j.amjms.2018.09.010.</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Tibaldi J.M. Evolution of Insulin Development: Focus on Key Parameters. Adv Ther. 2012;29(7):590–619. https://doi.org/10.1007/s12325-012-0034-8.</mixed-citation><mixed-citation xml:lang="en">Tibaldi J.M. Evolution of Insulin Development: Focus on Key Parameters. Adv Ther. 2012;29(7):590–619. https://doi.org/10.1007/s12325-012-0034-8.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Pettus J., Santos Cavaiola T., Tamborlane W.V., Edelman S. The Past, Present, and Future of Basal Insulins. Diabetes Metab Res Rev. 2016;32(6):478–496. https://doi.org/10.1002/dmrr.2763.</mixed-citation><mixed-citation xml:lang="en">Pettus J., Santos Cavaiola T., Tamborlane W.V., Edelman S. The Past, Present, and Future of Basal Insulins. Diabetes Metab Res Rev. 2016;32(6):478–496. https://doi.org/10.1002/dmrr.2763.</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Dailey G., Lavernia F. A Review of the Safety and Efficacy Data for Insulin Glargine 300 units/ml, a New Formulation of Insulin Glargine. Diabetes Obes Metab. 2015;17(12):1107–1114. https://doi.org/10.1111/dom.12531.</mixed-citation><mixed-citation xml:lang="en">Dailey G., Lavernia F. A Review of the Safety and Efficacy Data for Insulin Glargine 300 units/ml, a New Formulation of Insulin Glargine. Diabetes Obes Metab. 2015;17(12):1107–1114. https://doi.org/10.1111/dom.12531.</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Sutton G., Minguet J., Ferrero C., Bramlage P. U300, A Novel Long-Acting Insulin Formulation. Expert Opin Biol Ther. 2014;14(12):1849–1860. https://doi.org/10.1517/14712598.2014.970633.</mixed-citation><mixed-citation xml:lang="en">Sutton G., Minguet J., Ferrero C., Bramlage P. U300, A Novel Long-Acting Insulin Formulation. Expert Opin Biol Ther. 2014;14(12):1849–1860. https://doi.org/10.1517/14712598.2014.970633.</mixed-citation></citation-alternatives></ref><ref id="cit28"><label>28</label><citation-alternatives><mixed-citation xml:lang="ru">Riddle M.C., Bolli G.B., Ziemen M., Muehlen-Bartmer I., Bizet F., Home P.D. 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. https://doi.org/10.2337/dc14-0991.</mixed-citation><mixed-citation xml:lang="en">Riddle M.C., Bolli G.B., Ziemen M., Muehlen-Bartmer I., Bizet F., Home P.D. 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. https://doi.org/10.2337/dc14-0991.</mixed-citation></citation-alternatives></ref><ref id="cit29"><label>29</label><citation-alternatives><mixed-citation xml:lang="ru">Ghosh S., Ghosh R. Glargine-300: An Updated Literature Review on Randomized Controlled Trials and Real-World Studies. World J Diabetes. 2020;11(4):100–114. https://doi.org/10.4239/wjd.v11.i4.100.</mixed-citation><mixed-citation xml:lang="en">Ghosh S., Ghosh R. Glargine-300: An Updated Literature Review on Randomized Controlled Trials and Real-World Studies. World J Diabetes. 2020;11(4):100–114. https://doi.org/10.4239/wjd.v11.i4.100.</mixed-citation></citation-alternatives></ref><ref id="cit30"><label>30</label><citation-alternatives><mixed-citation xml:lang="ru">Yki-Järvinen H., Bergenstal R.M., Bolli G.B., Ziemen M., Wardecki M., MuehlenBartmer I. 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 Antihyperglycaemic Drugs: the EDITION 2 Randomized 12-Month Trial Including 6-Month Extension. Diabetes Obes Metab. 2015;17(12):1142–1149. https://doi.org/10.1111/dom.12532.</mixed-citation><mixed-citation xml:lang="en">Yki-Järvinen H., Bergenstal R.M., Bolli G.B., Ziemen M., Wardecki M., MuehlenBartmer I. 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 Antihyperglycaemic Drugs: the EDITION 2 Randomized 12-Month Trial Including 6-Month Extension. Diabetes Obes Metab. 2015;17(12):1142–1149. https://doi.org/10.1111/dom.12532.</mixed-citation></citation-alternatives></ref><ref id="cit31"><label>31</label><citation-alternatives><mixed-citation xml:lang="ru">Bolli G.B., Riddle M.C., Bergenstal R.M., Ziemen M., Sestakauskas K., Goyeau H., Home P.D. New Insulin Glargine 300 U/ml Compared with Glargine 100 U/ml in Insulin-Naïve People with Type 2 Diabetes on Oral Glucose-Lowering Drugs: A Randomized Controlled Trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386–394. https://doi.org/10.1111/dom.12438.</mixed-citation><mixed-citation xml:lang="en">Bolli G.B., Riddle M.C., Bergenstal R.M., Ziemen M., Sestakauskas K., Goyeau H., Home P.D. New Insulin Glargine 300 U/ml Compared with Glargine 100 U/ml in Insulin-Naïve People with Type 2 Diabetes on Oral Glucose-Lowering Drugs: A Randomized Controlled Trial (EDITION 3). Diabetes Obes Metab. 2015;17(4):386–394. https://doi.org/10.1111/dom.12438.</mixed-citation></citation-alternatives></ref><ref id="cit32"><label>32</label><citation-alternatives><mixed-citation xml:lang="ru">Ritzel R., Roussel R., Bolli G.B., Vinet L., Brulle-Wohlhueter C., Glezer S., YkiJärvinen H. Patient-Level Meta-Analysis of the EDITION 1, 2 and 3 Studies: Glycaemic Control and Hypoglycaemia with New Insulin Glargine 300 U/ml versus glargine 100 U/ml in People with Type 2 Diabetes. Diabetes Obes Metab. 2015;17(9):859–867. https://doi.org/10.1111/dom.12485.</mixed-citation><mixed-citation xml:lang="en">Ritzel R., Roussel R., Bolli G.B., Vinet L., Brulle-Wohlhueter C., Glezer S., YkiJärvinen H. Patient-Level Meta-Analysis of the EDITION 1, 2 and 3 Studies: Glycaemic Control and Hypoglycaemia with New Insulin Glargine 300 U/ml versus glargine 100 U/ml in People with Type 2 Diabetes. Diabetes Obes Metab. 2015;17(9):859–867. https://doi.org/10.1111/dom.12485.</mixed-citation></citation-alternatives></ref><ref id="cit33"><label>33</label><citation-alternatives><mixed-citation xml:lang="ru">Rosenstock J., Cheng A., Ritzel R., Bosnyak Z., Devisme C., Cali A.M.G. 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. https://doi.org/10.2337/dc18-0559.</mixed-citation><mixed-citation xml:lang="en">Rosenstock J., Cheng A., Ritzel R., Bosnyak Z., Devisme C., Cali A.M.G. 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. https://doi.org/10.2337/dc18-0559.</mixed-citation></citation-alternatives></ref><ref id="cit34"><label>34</label><citation-alternatives><mixed-citation xml:lang="ru">Kulozik F., Hasslacher C. Insulin Requirements in Patients with Diabetes and Declining Kidney Function: Differences between Insulin Analogues and Human Insulin? Ther Adv Endocrinol Metab. 2013;4(4):113–121. https://doi.org/10.1177/2042018813501188.</mixed-citation><mixed-citation xml:lang="en">Kulozik F., Hasslacher C. Insulin Requirements in Patients with Diabetes and Declining Kidney Function: Differences between Insulin Analogues and Human Insulin? Ther Adv Endocrinol Metab. 2013;4(4):113–121. https://doi.org/10.1177/2042018813501188.</mixed-citation></citation-alternatives></ref><ref id="cit35"><label>35</label><citation-alternatives><mixed-citation xml:lang="ru">Haluzik M., Philis‐Tsimikas A., Bosnyak Z., Muller‐Wieland D., Lauand F., Melas‐Melt L. et al. Differences in HbA1c-Lowering Effect and Hypoglycemia Risk between GLA-300 and IDeg According to Renal Function in the BRIGHT Trial. Diabetes. 2019;68(Suppl 1):146-OR. https://doi.org/10.2337/db19-146-OR.</mixed-citation><mixed-citation xml:lang="en">Haluzik M., Philis‐Tsimikas A., Bosnyak Z., Muller‐Wieland D., Lauand F., Melas‐Melt L. et al. Differences in HbA1c-Lowering Effect and Hypoglycemia Risk between GLA-300 and IDeg According to Renal Function in the BRIGHT Trial. Diabetes. 2019;68(Suppl 1):146-OR. https://doi.org/10.2337/db19-146-OR.</mixed-citation></citation-alternatives></ref><ref id="cit36"><label>36</label><citation-alternatives><mixed-citation xml:lang="ru">Haluzík M., Cheng A., Müller-Wieland D., Westerbacka J., Bosnyak Z., Lauand F. et al. Differential Glycaemic Control with Basal Insulin Glargine 300 U/mL versus Degludec 100 U/mL According to Kidney Function in Type 2 Diabetes: A Subanalysis from the BRIGHT Trial. Diabetes Obes Metab. 2020;22(8):1369–1377. https://doi.org/10.1111/dom.14043.</mixed-citation><mixed-citation xml:lang="en">Haluzík M., Cheng A., Müller-Wieland D., Westerbacka J., Bosnyak Z., Lauand F. et al. Differential Glycaemic Control with Basal Insulin Glargine 300 U/mL versus Degludec 100 U/mL According to Kidney Function in Type 2 Diabetes: A Subanalysis from the BRIGHT Trial. Diabetes Obes Metab. 2020;22(8):1369–1377. https://doi.org/10.1111/dom.14043.</mixed-citation></citation-alternatives></ref><ref id="cit37"><label>37</label><citation-alternatives><mixed-citation xml:lang="ru">Freeman J. Management of Hypoglycemia in Older Adults with Type 2 Diabetes. Postgrad Med. 2019;131(4):241–250. https://doi.org/10.1080/00325481.2019.1578590.</mixed-citation><mixed-citation xml:lang="en">Freeman J. Management of Hypoglycemia in Older Adults with Type 2 Diabetes. Postgrad Med. 2019;131(4):241–250. https://doi.org/10.1080/00325481.2019.1578590.</mixed-citation></citation-alternatives></ref><ref id="cit38"><label>38</label><citation-alternatives><mixed-citation xml:lang="ru">Russell-Jones D., Dauchy A., Delgado E., Dimitriadis G., Frandsen H.A., Popescu L. et al. Take Control: A Randomized Trial Evaluating the Efficacy and Safety Of Self- versus Physician-Managed Titration of Insulin Glargine 300 U/mL in Patients with Uncontrolled Type 2 Diabetes. Diabetes Obes Metab. 2019;21(7):1615–1624. https://doi.org/10.1111/dom.13697.</mixed-citation><mixed-citation xml:lang="en">Russell-Jones D., Dauchy A., Delgado E., Dimitriadis G., Frandsen H.A., Popescu L. et al. Take Control: A Randomized Trial Evaluating the Efficacy and Safety Of Self- versus Physician-Managed Titration of Insulin Glargine 300 U/mL in Patients with Uncontrolled Type 2 Diabetes. Diabetes Obes Metab. 2019;21(7):1615–1624. https://doi.org/10.1111/dom.13697.</mixed-citation></citation-alternatives></ref><ref id="cit39"><label>39</label><citation-alternatives><mixed-citation xml:lang="ru">Almalki M.H., Alshahrani F. Options for Controlling Type 2 Diabetes during Ramadan. Front Endocrinol (Lausanne). 2016;7:32. https://doi.org/10.3389/fendo.2016.00032.</mixed-citation><mixed-citation xml:lang="en">Almalki M.H., Alshahrani F. Options for Controlling Type 2 Diabetes during Ramadan. Front Endocrinol (Lausanne). 2016;7:32. https://doi.org/10.3389/fendo.2016.00032.</mixed-citation></citation-alternatives></ref><ref id="cit40"><label>40</label><citation-alternatives><mixed-citation xml:lang="ru">Hassanein M., Akif Buyukbese M., Malek R., Pilorget V., Naqvi M., Berthou B. et al. Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Who Fast during Ramadan: The Observational ORION Study. Diabetes Res Clin Pract. 2020;166:108189. https://doi.org/10.1016/j.diabres.2020.108189.</mixed-citation><mixed-citation xml:lang="en">Hassanein M., Akif Buyukbese M., Malek R., Pilorget V., Naqvi M., Berthou B. et al. Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL in Participants with Type 2 Diabetes Who Fast during Ramadan: The Observational ORION Study. Diabetes Res Clin Pract. 2020;166:108189. https://doi.org/10.1016/j.diabres.2020.108189.</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>
