medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2025-128medsovet-9078Research ArticleСАХАРНЫЙ ДИАБЕТDIABETES MELLITUSВсероссийская наблюдательная неинтервенционная программа изучения эффективности препарата Субетта в условиях реальной клинической практики у пациентов с предиабетом (СИЛА)All-Russian observational non-interventional program on the study of the efficacy of Subetta in real-world clinical practice in patients with prediabetes (SILA)https://orcid.org/0000-0003-3494-8011ЗиловА. В.ZilovA. V.

Зилов Алексей Владимирович, к.м.н., доцент кафедры эндокринологии №1 Института клинической медицины имени Н.В. Склифосовского

Scopus Author ID: 12786267500

119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2 

Alexey V. Zilov, Cand. Sci. (Med.), Associate Professor of Department of Endocrinology No. 1, Sklifosovsky Institute of Clinical Medicine

8, Bldg. 2, Trubetskaya St., Moscow, 119991, Russia

avzilov@hotmail.comhttps://orcid.org/0000-0002-1820-7726БолиеваЛ. З.BolievaL. Z.

Болиева Лаура Зелимхановна, д.м.н., профессор, заслуженный врач Республики Северная Осетия – Алания, главный внештатный специалист – пульмонолог, клинический фармаколог Минздрава Республики Северная Осетия – Алания, член президиума Российского научного медицинского общества терапевтов, заведующая кафедрой фармакологии с клинической фармакологией

Scopus Author ID: 12786267500

362019, Россия, Владикавказ, ул. Пушкинская, д. 40 

Laura Z. Bolieva, Dr. Sci. (Med.), Professor, Member of the Presidium of the Russian Scientific Medical Society of Internal Medicine, Honoured Doctor of the Republic of North Ossetia–Alania, Chief External Expert Pulmonologist, Clinical Pharmacologist of the Ministry of Health of the Republic of North Ossetia–Alania, Head of Department of Pharmacology and Clinical  Pharmacology

40, Pushkinskaya St., Republic of North Ossetia – Alania, Vladikavkaz, 362019, Russia

Scopus Author ID: 12786267500

bolievalz@mail.ruПервый Московский государственный медицинский университет имени И.М. Сеченова (Сеченовский Университет)РоссияSechenov First Moscow State Medical University (Sechenov University)Russian FederationСеверо-Осетинская государственная медицинская академияРоссияNorth Ossetian State Medical AcademyRussian Federation202524052025064047Copyright © Зилов А.В., Болиева Л.З., 20252025Зилов А.В., Болиева Л.З.Zilov A.V., Bolieva L.Z.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/9078

Введение. Лечение сахарного диабета 2-го типа и его осложнений является большим экономическим бременем для системы здравоохранения. Своевременное и качественное диспансерное наблюдение пациентов с предиабетом врачами первичного звена позволяет предотвратить развитие сахарного диабета и прогрессирование осложнений.Цель. Оценить опыт применения препарата Субетта в условиях реальной клинической практики у пациентов с предиабетом.Материалы и методы. Оценивалась 3-месячная монотерапия препаратом Субетта у 1 101 пациентов с верифицированным предиабетом, ранее не получавших сахароснижающее лечение. Период наблюдения за пациентами составил 12 нед., в течение которых они получали препарат Субетта по 2 таблетки 2 раза в день. Основными критериями эффективности явились: динамика глюкозы плазмы натощак, гликированного гемоглобина (HbA1c) и глюкозы плазмы через 2 ч после глюкозотолерантного теста (ПГТТ) по сравнению с исходными значениями через 3 мес. терапии препаратом Субетта.Результаты. За 12 нед. терапии препаратом Субетта показано значимое снижение всех исследуемых параметров углеводного обмена. Среднее снижение HbA1c среди всех пациентов с предиабетом составило 0,3% (p < 0,001). За наблюдаемый период 2-часовая глюкоза после проведения перорального глюкозотолерантного теста (ПГТТ) в среднем снизилась на 0,87 ммоль/л (p < 0,001). Среднее снижение глюкозы натощак составило 0,62 ммоль/л (p < 0,001). Проводимая терапия обладает высоким профилем безопасности, т. к. за время исследования было зарегистрировано всего 8 нежелательных явлений у 5 пациентов (0,5% случаев).Выводы. Проведенное исследование демонстрирует высокий профиль эффективности и безопасности препарата Субетта в монотерапии пациентов с предиабетом. За 3 мес. лечения примерно у 70% было достигнуто состояние нормогликемии по уровню глюкозы после проведения 2-часового ПГТТ.

Introduction. Treatment of type 2 diabetes mellitus (T2DM) and its complications impose a substantial economic burden on the healthcare system. Timely and high-quality follow-up monitoring of patients with prediabetes by primary care physicians helps prevent the development of diabetes mellitus and the progression of complications.Aim. To evaluate the experience of the use of Subetta in real-world clinical practice in patients with prediabetes. https://doi.org/10.21518/ms2025-128Materials and methods. A 3-month Subetta monotherapy was assessed in 1,101 patients with verified prediabetes who had not previously received antidiabetic treatment. The follow-up monitoring period was 12 weeks, during which the patients received Subetta at a dose of 2 tablets twice a day. The primary efficacy endpoints included changes in fasting plasma glucose levels, glycated hemoglobin (HbA1c) levels and OGTT two-hour blood glucose levels as compared with baseline values 3 months after Subetta therapy.Results. The 12-week Subetta therapy showed a significant decrease in all studied carbohydrate metabolism parameters. The average decrease in HbA1c levels among all patients with prediabetes was 0.3% (p < 0.001). Over the follow-up period, OGTT two-hour blood glucose levels decreased by an average of 0.87 mmol/l (p < 0.001). The average fasting glucose level decrease was 0.62 mmol/l (p < 0.001). This therapy had a high safety profile, as only 8 adverse events were recorded in 5 patients (0.5% of cases) during the study.Conclusions. The study demonstrated high efficacy and a favourable safety profile of Subetta in monotherapy of patients with prediabetes. After 3 months of treatment, normoglycemia state based on the OGTT two-hour blood glucose levels was achieved in approximately 70% of patients.

предиабетинсулинорезистентностьпрофилактика сахарного диабетаосложнениянарушения углеводного обменаprediabetesinsulin resistancediabetes preventioncomplicationscarbohydrate metabolism disordersReferencesParker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA et al. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2024;47(1):26–43. https://doi.org/10.2337/dci23-0085.Parker ED, Lin J, Mahoney T, Ume N, Yang G, Gabbay RA et al. Economic Costs of Diabetes in the U.S. in 2022. Diabetes Care. 2024;47(1):26–43. https://doi.org/10.2337/dci23-0085.Mori T, Nagata T, Nagata M, Fujimoto K, Fujino Y, Mori K. Diabetes severity measured by treatment control status and number of anti-diabetic drugs affects presenteeism among workers with type 2 diabetes. BMC Public Health. 2021;21:1865. https://doi.org/10.1186/s12889-021-11913-3.Mori T, Nagata T, Nagata M, Fujimoto K, Fujino Y, Mori K. Diabetes severity measured by treatment control status and number of anti-diabetic drugs affects presenteeism among workers with type 2 diabetes. BMC Public Health. 2021;21:1865. https://doi.org/10.1186/s12889-021-11913-3.Дедов ИИ, Концевая АВ, Шестакова МВ, Белоусов ЮБ, Баланова ЮА, Худяков МБ, Карпов ОИ. Экономические затраты на сахарный диабет 2 типа и его основные сердечно-сосудистые осложнения в Российской Федерации. Сахарный диабет. 2016;19(6):518–527. https://doi.org/10.14341/DM8153.Dedov II, Koncevaya AV, Shestakova MV, Belousov YuB, Balanova JA, Khudyakov MB, Karpov OI. Economic evaluation of type 2 diabetes mellitus burden and its main cardiovascular complications in the Russian Federation. Diabetes Mellitus. 2016;19(6):518–527. (In Russ.) https://doi.org/10.14341/DM8153.Khan RMM, Chua ZJY, Tan JC, Yang Y, Liao Z, Zhao Y. From Pre-Diabetes to Diabetes: Diagnosis, Treatments and Translational Research. Medicina. 2019;55(9):546. https://doi.org/10.3390/medicina55090546.Khan RMM, Chua ZJY, Tan JC, Yang Y, Liao Z, Zhao Y. From Pre-Diabetes to Diabetes: Diagnosis, Treatments and Translational Research. Medicina. 2019;55(9):546. https://doi.org/10.3390/medicina55090546.Lawrence J, Robinson A. Screening for diabetes in general practice. Prev Cardiol. 2003;6(2):78–84. https://doi.org/10.1111/j.1520-037x.2003.01662.x.Lawrence J, Robinson A. Screening for diabetes in general practice. Prev Cardiol. 2003;6(2):78–84. https://doi.org/10.1111/j.1520-037x.2003.01662.x.Ndumele CE, Rangaswami J, Chow SL, Neeland IJ, Tuttle KR, Khan SS et al. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association. Circulation. 2023;148(20):1606–1635. https://doi.org/10.1161/CIR.0000000000001184.Ndumele CE, Rangaswami J, Chow SL, Neeland IJ, Tuttle KR, Khan SS et al. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association. Circulation. 2023;148(20):1606–1635. https://doi.org/10.1161/CIR.0000000000001184.Riddle M, Umpierrez G, DiGenio A, Zhou R, Rosenstock J. Contributions of basal and postprandial hyperglycemia over a wide range of A1C levels before and after treatment intensification in type 2 diabetes. Diabetes Care. 2011;34(12):2508–2514. https://doi.org/10.2337/dc11-0632.Riddle M, Umpierrez G, DiGenio A, Zhou R, Rosenstock J. Contributions of basal and postprandial hyperglycemia over a wide range of A1C levels before and after treatment intensification in type 2 diabetes. Diabetes Care. 2011;34(12):2508–2514. https://doi.org/10.2337/dc11-0632.Cai X, Zhang Y, Li M, Wu JH, Mai L, Li J et al. Association between prediabetes and risk of all cause mortality and cardiovascular disease: updated meta-analysis. BMJ. 2020;370:m2297. https://doi.org/10.1136/bmj.m2297.Cai X, Zhang Y, Li M, Wu JH, Mai L, Li J et al. Association between prediabetes and risk of all cause mortality and cardiovascular disease: updated meta-analysis. BMJ. 2020;370:m2297. https://doi.org/10.1136/bmj.m2297.Yue L, Tian Y, Ma M, Jing L, Sun Q, Shi L et al. Prevalence of prediabetes and risk of CVD mortality in individuals with prediabetes alone or plus hypertension in Northeast China: insight from a population based cohort study. BMC Public Health. 2024;24(1):475. https://doi.org/10.1186/s12889-024-17996-y.Yue L, Tian Y, Ma M, Jing L, Sun Q, Shi L et al. Prevalence of prediabetes and risk of CVD mortality in individuals with prediabetes alone or plus hypertension in Northeast China: insight from a population based cohort study. BMC Public Health. 2024;24(1):475. https://doi.org/10.1186/s12889-024-17996-y.Schlesinger S, Neuenschwander M, Barbaresko J, Lang A, Maalmi H, Rathmann W et al. Prediabetes and risk of mortality, diabetes-related complications and comorbidities: umbrella review of meta-analyses of prospective studies. Diabetologia. 2022;65(2):275–285. https://doi.org/10.1007/s00125-021-05592-3.Schlesinger S, Neuenschwander M, Barbaresko J, Lang A, Maalmi H, Rathmann W et al. Prediabetes and risk of mortality, diabetes-related complications and comorbidities: umbrella review of meta-analyses of prospective studies. Diabetologia. 2022;65(2):275–285. https://doi.org/10.1007/s00125-021-05592-3.Gujral UP, Jagannathan R, He S, Huang M, Staimez LR, Wei J et al. Association between varying cut-points of intermediate hyperglycemia and risk of mortality, cardiovascular events and chronic kidney disease: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2021;9(1):e001776. https://doi.org/10.1136/bmjdrc-2020-001776.Gujral UP, Jagannathan R, He S, Huang M, Staimez LR, Wei J et al. Association between varying cut-points of intermediate hyperglycemia and risk of mortality, cardiovascular events and chronic kidney disease: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2021;9(1):e001776. https://doi.org/10.1136/bmjdrc-2020-001776.Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25(12):2165–2171. https://doi.org/10.2337/diacare.25.12.2165.Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002;25(12):2165–2171. https://doi.org/10.2337/diacare.25.12.2165.Amer BE, Abdelgalil MS, Hamad AA, Elarabi A, Abozaid AM, Abd-ElGawad M. Metformin plus lifestyle interventions versus lifestyle interventions alone for the delay or prevention of type 2 diabetes in individuals with prediabetes: a meta-analysis of randomized controlled trials. Diabetol Metab Syndr. 2024;16(1):273. https://doi.org/10.1186/s13098-024-01504-8Amer BE, Abdelgalil MS, Hamad AA, Elarabi A, Abozaid AM, Abd-ElGawad M. Metformin plus lifestyle interventions versus lifestyle interventions alone for the delay or prevention of type 2 diabetes in individuals with prediabetes: a meta-analysis of randomized controlled trials. Diabetol Metab Syndr. 2024;16(1):273. https://doi.org/10.1186/s13098-024-01504-8Zhuo X, Zhang P, Hoerger TJ. Lifetime direct medical costs of treating type 2 diabetes and diabetic complications. Am J Prev Med. 2013;45(3):253–261. https://doi.org/10.1016/j.amepre.2013.04.017.Zhuo X, Zhang P, Hoerger TJ. Lifetime direct medical costs of treating type 2 diabetes and diabetic complications. Am J Prev Med. 2013;45(3):253–261. https://doi.org/10.1016/j.amepre.2013.04.017.Tuso P. Prediabetes and Lifestyle Modification: Time to Prevent a Preventable Disease. Perm J. 2014;18:88–93. https://doi.org/10.7812/TPP/14-002.Tuso P. Prediabetes and Lifestyle Modification: Time to Prevent a Preventable Disease. Perm J. 2014;18:88–93. https://doi.org/10.7812/TPP/14-002.Дедов ИИ, Шестакова МВ, Галстян ГР. Распространенность сахарного диабета 2 типа у взрослого населения России (исследование NATION). Сахарный диабет. 2016;19(2):104–112. https://doi.org/10.14341/DM2004116-17.Dedov II, Shestakova MV, Galstyan GR. The prevalence of type 2 diabetes mellitus in the adult population of Russia (NATION study). Diabetes Mellitus. 2016;19(2):104–112. (In Russ.) https://doi.org/10.14341/DM2004116-17.Зилов АВ, Болиева ЛЗ. Современные возможности профилактики и коррекции нарушений углеводного обмена. Медицинский совет. 2024;18(23):144–150. https://doi.org/10.21518/ms2024-540.Zilov AV, Bolieva LZ. Current opportunities for the prevention and treatment of carbohydrate metabolism disorders. Meditsinskiy Sovet. 2024;18(23):144–150. (In Russ.) https://doi.org/10.21518/ms2024-540.Mkrtumyan A, Ametov A, Demidova T, Volkova A, Dudinskaya E, Vertkin A, Vorobiev S. A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, DoubleBlind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta. J Clin Med. 2022;11(5):1390. https://doi.org/10.3390/jcm11051390.Mkrtumyan A, Ametov A, Demidova T, Volkova A, Dudinskaya E, Vertkin A, Vorobiev S. A New Approach to Overcome Insulin Resistance in Patients with Impaired Glucose Tolerance: The Results of a Multicenter, DoubleBlind, Placebo-Controlled, Randomized Clinical Trial of Efficacy and Safety of Subetta. J Clin Med. 2022;11(5):1390. https://doi.org/10.3390/jcm11051390.Shepard JG, Airee A, Dake AW, McFarland MS, Vora A. Limitations of A1c Interpretation. South Med J. 2015;108(12):724–729. https://doi.org/10.14423/SMJ.0000000000000381.Shepard JG, Airee A, Dake AW, McFarland MS, Vora A. Limitations of A1c Interpretation. South Med J. 2015;108(12):724–729. https://doi.org/10.14423/SMJ.0000000000000381.Wang D, Wang J, Liu J, Qin Y, Lou P, Zhang Y et al. The Role of Cumulative Mean Arterial Pressure Levels in First Stroke Events Among Adults with Hypertension: A 10-Year Prospective Cohort Study. Clin Epidemiol. 2022;14:665–676. https://doi.org/10.2147/CLEP.S359284.Wang D, Wang J, Liu J, Qin Y, Lou P, Zhang Y et al. The Role of Cumulative Mean Arterial Pressure Levels in First Stroke Events Among Adults with Hypertension: A 10-Year Prospective Cohort Study. Clin Epidemiol. 2022;14:665–676. https://doi.org/10.2147/CLEP.S359284.Антропова ОН, Осипова ИВ. Высокое нормальное артериальное давление: распространенность и прогностическое значение. Профилактическая медицина. 2015;18(5):60–62. https://doi.org/10.17116/profmed201518560-62.Antropova ON, Osipova IV. High normal blood pressure: Prevalence and prognostic significance. Profilakticheskaya Meditsina. 2015;18(5):60–62. (In Russ.) https://doi.org/10.17116/profmed201518560-62.Antropova ON, Osipova IV. High normal blood pressure: Prevalence and prognostic significance. Profilakticheskaya Meditsina. 2015;18(5):60–62. (In Russ.) https://doi.org/10.17116/profmed201518560-62.Gao Q, Lin Y, Xu R, Zhang Y, Luo F, Chen R et al. Association between mean arterial pressure and clinical outcomes among patients with heart failure. ESC Heart Fail. 2023;10(4):2362–2374. https://doi.org/10.1002/ehf2.14401.Gao Q, Lin Y, Xu R, Zhang Y, Luo F, Chen R et al. Association between mean arterial pressure and clinical outcomes among patients with heart failure. ESC Heart Fail. 2023;10(4):2362–2374. https://doi.org/10.1002/ehf2.14401.Petrova NV, Tarasov SA, Epstein OI, Dubroca C, Sulpice T. Highly diluted antibodies to eNOS restore endothelium function in aortic rings from hypertensive rats. Dose Response. 2022;20(2):15593258221099281. https://doi.org/10.1177/15593258221099281.Petrova NV, Tarasov SA, Epstein OI, Dubroca C, Sulpice T. Highly diluted antibodies to eNOS restore endothelium function in aortic rings from hypertensive rats. Dose Response. 2022;20(2):15593258221099281. https://doi.org/10.1177/15593258221099281.Boland W, Li WS, Dilly CK. Accommodating patients with obesity in ambulatory care: A clinical environment checklist. Obes Sci Pract. 2024;10(5):e70006. https://doi.org/10.1002/osp4.70006.Boland W, Li WS, Dilly CK. Accommodating patients with obesity in ambulatory care: A clinical environment checklist. Obes Sci Pract. 2024;10(5):e70006. https://doi.org/10.1002/osp4.70006.Cercato C, Fonseca FA. Cardiovascular risk and obesity. Diabetol Metab Syndr. 2019;11:74. https://doi.org/10.1186/s13098-019-0468-0.Cercato C, Fonseca FA. Cardiovascular risk and obesity. Diabetol Metab Syndr. 2019;11:74. https://doi.org/10.1186/s13098-019-0468-0.Mkrtumyan AM. Medical and social portrait of a patient with newly diagnosed diabetes mellitus on the example of the selection of participants in a clinical study of the treatment of impaired glucose tolerance. Effective Pharmacotherapy. 2023;19(21):8–14. (In Russ.) https://doi.org/10.33978/2307-3586-2023-19-21-8-14.Мкртумян АМ. Медико-социальный портрет пациента с впервые выявленным сахарным диабетом на примере отбора участников в клиническое исследование лечения нарушенной толерантности к глюкозе. Эффективная фармакотерапия. 2023;19(21):8–14. https://doi.org/10.33978/2307-3586-2023-19-21-8-14.Yordanova S, Mitov K, Kamusheva M. Cost-effectiveness of treatment intervention in prediabetic patients in Bulgaria. Pharmacia. 2023;70(3):809–816. https://doi.org/10.3897/pharmacia.70.e110104.Yordanova S, Mitov K, Kamusheva M. Cost-effectiveness of treatment intervention in prediabetic patients in Bulgaria. Pharmacia. 2023;70(3):809–816. https://doi.org/10.3897/pharmacia.70.e110104.Svetlichnaya SV, Popovich LD. Economics of diabetes mellitus type 2 control based on big data modeling. Real-World Data & Evidence. 2024;4(1):14–23. (In Russ.) https://doi.org/10.37489/2782–3784-myrwd-47.Светличная СВ, Попович ЛД. Экономика контроля сахарного диабета 2 типа на основе моделирования больших данных. Реальная клиническая практика: данные и доказательства. 2024;4(1):14–23. https://doi.org/10.37489/2782-3784-myrwd-47.Dedov II, Shestakova MV, Vikulova OK, Zheleznyakova AV, Isakov MA, Sazonova DV, Mokrysheva NG. Diabetes mellitus in the Russian Federation: dynamics of epidemiological indicators according to the Federal Register of Diabetes Mellitus for the period 2010–2022. Diabetes Mellitus. 2023;26(2):104–123. (In Russ.) https://doi.org/10.14341/DM13035.Дедов ИИ, Шестакова МВ, Викулова ОК, Железнякова АВ, Исаков МА, Сазонова ДВ, Мокрышева НГ. Сахарный диабет в Российской Федерации: динамика эпидемиологических показателей по данным Федерального регистра сахарного диабета за период 2010—2022 гг. Сахарный диабет. 2023;26(2):104–123. https://doi.org/10.14341/DM13035.Дедов ИИ, Шестакова МВ, Викулова ОК, Железнякова АВ, Исаков МА, Сазонова ДВ, Мокрышева НГ. Сахарный диабет в Российской Федерации: динамика эпидемиологических показателей по данным Федерального регистра сахарного диабета за период 2010—2022 гг. Сахарный диабет. 2023;26(2):104–123. https://doi.org/10.14341/DM13035.

The authors declare that there are no conflicts of interest present.