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Аналоги инсулина сверхбыстрого действия: превосходство в лечении сахарного диабета 1-го и 2-го типа - Журнал Терапевтический архив №10 Вопросы эндокринологии 2025
Аналоги инсулина сверхбыстрого действия: превосходство в лечении сахарного диабета 1-го и 2-го типа
Демидова Т.Ю., Титова В.В. Аналоги инсулина сверхбыстрого действия: превосходство в лечении сахарного диабета 1-го и 2-го типа. Терапевтический архив. 2025;97(10):883–889. DOI: 10.26442/00403660.2025.10.203482
© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.
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Аннотация
Аналоги инсулина сверхбыстрого действия созданы для достижения более физиологичного профиля действия с быстрым и выраженным начальным пиком всасывания. Ускоренное всасывание сверхбыстродействующих аналогов инсулина приводит к более быстрому началу действия, при этом концентрация инсулина достигает пика в кровотоке раньше по сравнению с ультракороткими аналогами инсулина. Такой быстрый пик действия инсулина лучше соответствует постпрандиальному профилю всасывания глюкозы, что приводит к улучшению гликемического контроля и снижению риска постпрандиальной гипергликемии. Соответственно, быстрое начало и окончание действия аналогов инсулина сверхбыстрого действия обеспечивают большую гибкость в корректировке доз инсулина на основе содержания углеводов в пище и уровня физической активности. Более короткая продолжительность действия позволяет сократить частоту гипогликемических событий, может улучшить общее качество жизни и уменьшить страх гипогликемии, который является серьезной проблемой для многих пациентов с сахарным диабетом. Использование аналогов инсулина сверхбыстрого действия показало свою эффективность в компенсации постпрандиальной гипергликемии и снижении вариабельности глюкозы в разных группах пациентов, включая больных сахарным диабетом 1 и 2-го типа, детей и беременных женщин, кроме того, их использование в системах с замкнутым контуром показывает многообещающие результаты в улучшении гликемических показателей.
Ключевые слова: сахарный диабет, сверхбыстрый инсулин, гликемический контроль, гипогликемия, аналоги инсулина, инсулинотерапия
Keywords: diabetes mellitus, ultra-rapid insulin, glycemic control, hypoglycemia, insulin analogues, insulin therapy
Ключевые слова: сахарный диабет, сверхбыстрый инсулин, гликемический контроль, гипогликемия, аналоги инсулина, инсулинотерапия
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Keywords: diabetes mellitus, ultra-rapid insulin, glycemic control, hypoglycemia, insulin analogues, insulin therapy
Полный текст
Список литературы
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2. Demidova TY, Titova VV. Insulin therapy is a personalized approach to glycemic management in diabetes. Terapevticheskii Arkhiv (Ter. Arkh.). 2021;92(12):201-6 (in Russian). DOI:10.26442/00403660.2020.12.200449
3. Chen G, Yu J, Gu Z. Glucose-Responsive Microneedle Patches for Diabetes Treatment. J Diabetes Sci Technol. 2019;13(1):41-8. DOI:10.1177/1932296818778607
4. Evans M, Wilkinson M, Giannpolou A. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin. Diabetes Ther. 2019;10(5):1793-800. DOI:10.1007/s13300-019-00685-0
5. Kurtzhals P, Nishimura E, Haahr H, et al. Commemorating insulin's centennial: engineering insulin pharmacology towards physiology. Trends Pharmacol Sci. 2021;42(8):620-39. DOI:10.1016/j.tips.2021.05.005
6. Demidova TY, Izmaylova MY. Fast-acting insulin aspart – from insulin portraits to patient portraits. Meditsinskiy sovet = Medical Council. 2021;(7):8-16 (in Russian. DOI:10.21518/2079-701x-2021-7-8-16
7. Heise T, Stender-Petersen K, Hövelmann U, et al. Pharmacokinetic and Pharmacodynamic Properties of Faster-Acting Insulin Aspart versus Insulin Aspart Across a Clinically Relevant Dose Range in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2017;56(6):649-60. DOI:10.1007/s40262-016-0473-5
8. Heise T, Linnebjerg H, Coutant D, et al. Ultra rapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study. Diabetes Obes Metab. 2020;22(10):1789-878. DOI:10.1111/dom.14094
9. Leohr J, Dellva MA, LaBell E, et al. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020;42(9):1762-77.e4. DOI:10.1016/j.clinthera.2020.07.005
10. Kazda C, Leohr J, Liu R, et al. Ultra rapid lispro (URLi) shows accelerated pharmacokinetics and greater reduction in postprandial glucose versus Humalog® in patients with type 1 diabetes mellitus in a randomized, double-blind meal test early-phase study. Diabetes Obes Metab. 2022;24(2):196-203. DOI:10.1111/dom.14563
11. Leohr J, Kazda C, Liu R, et al. Ultra-rapid lispro shows faster pharmacokinetics and reduces postprandial glucose excursions versus Humalog® in patients with type 2 diabetes mellitus in a randomized, controlled crossover meal test early phase study. Diabetes Obes Metab. 2022;24(2):187-95. DOI:10.1111/dom.14561
12. Suplotova LA, Tilkiyan AS. Ultrafast-acting insulin: pharmacological properties and their impact on clinical aspects. Meditsinskiy sovet = Medical Council. 2024;(13):146-54 (in Russian). DOI:10.21518/ms2024-262
13. Heise T, Pieber TR, Danne T, et al. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017;56(5):551-5. DOI:10.1007/s40262-017-0514-8
14. Kazda CM, Leohr J, Liu R, et al. Ultra-rapid Lispro (URLi) Shows Faster Absorption of Insulin Lispro vs. Humalog® during Insulin Pump (CSII) Use in Patients with T1D. Diabetes. 2018;67(Suppl. 1). DOI:10.2337/db18-1006-p
15. Russell-Jones D, Bode BW, De Block C, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017;40(7):943-50. DOI:10.2337/dc16-1771
16. Mathieu C, Bode BW, Franek E, et al. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018;20(5):1148-215. DOI:10.1111/dom.13205
17. Bowering K, Case C, Harvey J, et al. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The ONSET 2 Trial. Diabetes Care. 2017;40(7):951-5. DOI:10.2337/dc16-1770
18. Malecki MT, Cao D, Liu R, et al. Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy. Diabetes Technol Ther. 2020;22(11):853-60. DOI:10.1089/dia.2020.0129
19. Zhang Q, Chigutsa F, Chang AM. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study. Diabetes Ther. 2022;13(8):1547-57. DOI:10.1007/s13300-022-01290-4
20. Danne T, Axel Schweitzer M, Keuthage W, et al. Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study. Diabetes Technol Ther. 2021;23(3):203-12. DOI:10.1089/dia.2020.0360
21. Pal R, Banerjee M, Bhadada SK. Glycaemic efficacy and safety of mealtime faster-acting insulin aspart administered by injection as compared to insulin aspart in people with diabetes mellitus: A meta-analysis of randomized controlled trials. Diabet Med. 2021;38(3):e14515. DOI:10.1111/dme.14515
22. Madsbad S. Impact of postprandial glucose control on diabetes-related complications: How is the evidence evolving? J Diabetes Complications. 2016;30(2):374-85. DOI:10.1016/j.jdiacomp.2015.09.019
23. Riddle MC. Basal Glucose Can Be Controlled, but the Prandial Problem Persists – It's the Next Target! Diabetes Care. 2017;40(3):291-300. DOI:10.2337/dc16-2380
24. Lefever E, Vliebergh J, Mathieu C. Improving the treatment of patients with diabetes using insulin analogues: current findings and future directions. Expert Opin Drug Saf. 2021;20(2):155-69. DOI:10.1080/14740338.2021.1856813
25. Mannucci E, Monami M, Lamanna C, Adalsteinsson JE. Post-prandial glucose and diabetic complications: systematic review of observational studies. Acta Diabetol. 2012;49(4):307-14. DOI:10.1007/s00592-011-0355-0
26. Heise T, Piras de Oliveira C, Juneja R, et al. What is the value of faster acting prandial insulin? Focus on ultra rapid lispro. Diabetes Obes Metab. 2022;24(9):1689-701. DOI:10.1111/dom.14773
27. Klonoff DC, Evans ML, Lane W, et al. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019;21(4):961-6. DOI:10.1111/dom.13610
28. Warren M, Bode B, Cho JI, et al. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes Obes Metab. 2021;23(7):1552-51. DOI:10.1111/dom.14368
29. Bode B, Carlson A, Liu R, et al. Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a Hybrid Closed-Loop System. Diabetes Technol Ther. 2021;23(12):828-36. DOI:10.1089/dia.2021.0184
30. Ware J, Allen JM, Boughton CK, et al. Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study. Diabetes Technol Ther. 2023;25(6):431-3. DOI:10.1089/dia.2023.0042
31. Hsu L, Buckingham B, Basina M, et al. Fast-Acting Insulin Aspart Use with the MiniMed(TM) 670G System. Diabetes Technol Ther. 2021;23(1):1-7. DOI:10.1089/dia.2020.0083
32. Nwokolo M, Lakshman R, Hartnell S, et al. CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study. Diabetes Technol Ther. 2023;25(12):856-63. DOI:10.1089/dia.2023.0262
33. Ozer K, Cooper AM, Ahn LP, et al. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021;23(4):286-92. DOI:10.1089/dia.2020.0500
34. Boughton CK, Hartnell S, Thabit H, et al. Hybrid closed-loop glucose control with faster insulin aspart compared with standard insulin aspart in adults with type 1 diabetes: A double-blind, multicentre, multinational, randomized, crossover study. Diabetes Obes Metab. 2021;23(6):1389-436. DOI:10.1111/dom.14355
35. Dovc K, Piona C, Yeşiltepe Mutlu G, et al. Faster Compared With Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial. Diabetes Care. 2020;43(1):29-36. DOI:10.2337/dc19-0895
36. Bode BW, Iotova V, Kovarenko M, et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The ONSET 7 Trial. Diabetes Care. 2019;42(7):1255-22. DOI:10.2337/dc19-0009
37. Wadwa RP, Laffel LM, Franco DR, et al. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial. Diabetes Obes Metab. 2023;25(1):89-97. DOI:10.1111/dom.14849
38. Cengiz E, Danne T, Ahmad T, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2022;23(8):1277-26. DOI:10.1111/pedi.13442
39. González de Buitrago Amigo J, González García A, Díaz Fernández P, et al. The impact of "faster aspart" on blood glucose control in children and adolescents with type 1 diabetes treated using a sensor-augmented insulin pump. An Pediatr (Engl Ed). 2021;95(5):321-2. DOI:10.1016/j.anpede.2020.11.006
40. Dovc K, Bergford S, Fröhlich-Reiterer E, et al. A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial. Diabetes Technol Ther. 2023;25(9):612-21. DOI:10.1089/dia.2023.0178
41. Costa C, Linhares MI, Bastos F, et al. Effect of ultra-rapid insulin aspart on glycemic control in children with type 1 diabetes: the experience of a Portuguese tertiary centre. Diabetol Int. 2022;13(3):531-3. DOI:10.1007/s13340-021-00565-8
42. Wong EY, Kroon L. Ultra-Rapid-Acting Insulins: How Fast Is Really Needed? Clin Diabetes. 2021;39(4):415-23. DOI:10.2337/cd20-0119
43. Ghosh A. Efficacy and Safety of Faster Aspart in Comparison to Insulin Aspart Among Indian Women with Gestational Diabetes. Curr Diabetes Rev. 2023;19(8):e221222212124. DOI:10.2174/1573399819666221222154443
44. Nørgaard SK, Søholm JC, Mathiesen ER, et al. Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023;11(11):811-21. DOI:10.1016/S2213-8587(23)00236-X
2. Демидова Т.Ю., Титова В.В. Инсулинотерапия – персонализированный подход к управлению гликемией при сахарном диабете. Терапевтический архив. 2021;92(12):201-6 [Demidova TY, Titova VV. Insulin therapy is a personalized approach to glycemic management in diabetes. Terapevticheskii Arkhiv (Ter. Arkh.). 2021;92(12):201-6 (in Russian)]. DOI:10.26442/00403660.2020.12.200449
3. Chen G, Yu J, Gu Z. Glucose-Responsive Microneedle Patches for Diabetes Treatment. J Diabetes Sci Technol. 2019;13(1):41-8. DOI:10.1177/1932296818778607
4. Evans M, Wilkinson M, Giannpolou A. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin. Diabetes Ther. 2019;10(5):1793-800. DOI:10.1007/s13300-019-00685-0
5. Kurtzhals P, Nishimura E, Haahr H, et al. Commemorating insulin's centennial: engineering insulin pharmacology towards physiology. Trends Pharmacol Sci. 2021;42(8):620-39. DOI:10.1016/j.tips.2021.05.005
6. Демидова Т.Ю., Измайлова М.Я. Сверхбыстродействующий инсулин аспарт – от портрета инсулина к портретам пациентов. Медицинский Совет. 2021;(7):8-16 [Demidova TY, Izmaylova MY. Fast-acting insulin aspart – from insulin portraits to patient portraits. Meditsinskiy sovet = Medical Council. 2021;(7):8-16 (in Russian)]. DOI:10.21518/2079-701x-2021-7-8-16
7. Heise T, Stender-Petersen K, Hövelmann U, et al. Pharmacokinetic and Pharmacodynamic Properties of Faster-Acting Insulin Aspart versus Insulin Aspart Across a Clinically Relevant Dose Range in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2017;56(6):649-60. DOI:10.1007/s40262-016-0473-5
8. Heise T, Linnebjerg H, Coutant D, et al. Ultra rapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study. Diabetes Obes Metab. 2020;22(10):1789-878. DOI:10.1111/dom.14094
9. Leohr J, Dellva MA, LaBell E, et al. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020;42(9):1762-77.e4. DOI:10.1016/j.clinthera.2020.07.005
10. Kazda C, Leohr J, Liu R, et al. Ultra rapid lispro (URLi) shows accelerated pharmacokinetics and greater reduction in postprandial glucose versus Humalog® in patients with type 1 diabetes mellitus in a randomized, double-blind meal test early-phase study. Diabetes Obes Metab. 2022;24(2):196-203. DOI:10.1111/dom.14563
11. Leohr J, Kazda C, Liu R, et al. Ultra-rapid lispro shows faster pharmacokinetics and reduces postprandial glucose excursions versus Humalog® in patients with type 2 diabetes mellitus in a randomized, controlled crossover meal test early phase study. Diabetes Obes Metab. 2022;24(2):187-95. DOI:10.1111/dom.14561
12. Суплотова Л.А., Тилкиян А.Ш. Сверхбыстрые инсулины: фармакологические свойства и их влияние на клинические аспекты. Медицинский Совет. 2024;(13):146-54 [Suplotova LA, Tilkiyan AS. Ultrafast-acting insulin: pharmacological properties and their impact on clinical aspects. Meditsinskiy sovet = Medical Council. 2024;(13):146-54 (in Russian)]. DOI:10.21518/ms2024-262
13. Heise T, Pieber TR, Danne T, et al. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017;56(5):551-5. DOI:10.1007/s40262-017-0514-8
14. Kazda CM, Leohr J, Liu R, et al. Ultra-rapid Lispro (URLi) Shows Faster Absorption of Insulin Lispro vs. Humalog® during Insulin Pump (CSII) Use in Patients with T1D. Diabetes. 2018;67(Suppl. 1). DOI:10.2337/db18-1006-p
15. Russell-Jones D, Bode BW, De Block C, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017;40(7):943-50. DOI:10.2337/dc16-1771
16. Mathieu C, Bode BW, Franek E, et al. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018;20(5):1148-215. DOI:10.1111/dom.13205
17. Bowering K, Case C, Harvey J, et al. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The ONSET 2 Trial. Diabetes Care. 2017;40(7):951-5. DOI:10.2337/dc16-1770
18. Malecki MT, Cao D, Liu R, et al. Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy. Diabetes Technol Ther. 2020;22(11):853-60. DOI:10.1089/dia.2020.0129
19. Zhang Q, Chigutsa F, Chang AM. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study. Diabetes Ther. 2022;13(8):1547-57. DOI:10.1007/s13300-022-01290-4
20. Danne T, Axel Schweitzer M, Keuthage W, et al. Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study. Diabetes Technol Ther. 2021;23(3):203-12. DOI:10.1089/dia.2020.0360
21. Pal R, Banerjee M, Bhadada SK. Glycaemic efficacy and safety of mealtime faster-acting insulin aspart administered by injection as compared to insulin aspart in people with diabetes mellitus: A meta-analysis of randomized controlled trials. Diabet Med. 2021;38(3):e14515. DOI:10.1111/dme.14515
22. Madsbad S. Impact of postprandial glucose control on diabetes-related complications: How is the evidence evolving? J Diabetes Complications. 2016;30(2):374-85. DOI:10.1016/j.jdiacomp.2015.09.019
23. Riddle MC. Basal Glucose Can Be Controlled, but the Prandial Problem Persists – It's the Next Target! Diabetes Care. 2017;40(3):291-300. DOI:10.2337/dc16-2380
24. Lefever E, Vliebergh J, Mathieu C. Improving the treatment of patients with diabetes using insulin analogues: current findings and future directions. Expert Opin Drug Saf. 2021;20(2):155-69. DOI:10.1080/14740338.2021.1856813
25. Mannucci E, Monami M, Lamanna C, Adalsteinsson JE. Post-prandial glucose and diabetic complications: systematic review of observational studies. Acta Diabetol. 2012;49(4):307-14. DOI:10.1007/s00592-011-0355-0
26. Heise T, Piras de Oliveira C, Juneja R, et al. What is the value of faster acting prandial insulin? Focus on ultra rapid lispro. Diabetes Obes Metab. 2022;24(9):1689-701. DOI:10.1111/dom.14773
27. Klonoff DC, Evans ML, Lane W, et al. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019;21(4):961-6. DOI:10.1111/dom.13610
28. Warren M, Bode B, Cho JI, et al. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes Obes Metab. 2021;23(7):1552-51. DOI:10.1111/dom.14368
29. Bode B, Carlson A, Liu R, et al. Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a Hybrid Closed-Loop System. Diabetes Technol Ther. 2021;23(12):828-36. DOI:10.1089/dia.2021.0184
30. Ware J, Allen JM, Boughton CK, et al. Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study. Diabetes Technol Ther. 2023;25(6):431-3. DOI:10.1089/dia.2023.0042
31. Hsu L, Buckingham B, Basina M, et al. Fast-Acting Insulin Aspart Use with the MiniMed(TM) 670G System. Diabetes Technol Ther. 2021;23(1):1-7. DOI:10.1089/dia.2020.0083
32. Nwokolo M, Lakshman R, Hartnell S, et al. CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study. Diabetes Technol Ther. 2023;25(12):856-63. DOI:10.1089/dia.2023.0262
33. Ozer K, Cooper AM, Ahn LP, et al. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021;23(4):286-92. DOI:10.1089/dia.2020.0500
34. Boughton CK, Hartnell S, Thabit H, et al. Hybrid closed-loop glucose control with faster insulin aspart compared with standard insulin aspart in adults with type 1 diabetes: A double-blind, multicentre, multinational, randomized, crossover study. Diabetes Obes Metab. 2021;23(6):1389-436. DOI:10.1111/dom.14355
35. Dovc K, Piona C, Yeşiltepe Mutlu G, et al. Faster Compared With Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial. Diabetes Care. 2020;43(1):29-36. DOI:10.2337/dc19-0895
36. Bode BW, Iotova V, Kovarenko M, et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The ONSET 7 Trial. Diabetes Care. 2019;42(7):1255-22. DOI:10.2337/dc19-0009
37. Wadwa RP, Laffel LM, Franco DR, et al. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial. Diabetes Obes Metab. 2023;25(1):89-97. DOI:10.1111/dom.14849
38. Cengiz E, Danne T, Ahmad T, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2022;23(8):1277-26. DOI:10.1111/pedi.13442
39. González de Buitrago Amigo J, González García A, Díaz Fernández P, et al. The impact of "faster aspart" on blood glucose control in children and adolescents with type 1 diabetes treated using a sensor-augmented insulin pump. An Pediatr (Engl Ed). 2021;95(5):321-2. DOI:10.1016/j.anpede.2020.11.006
40. Dovc K, Bergford S, Fröhlich-Reiterer E, et al. A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial. Diabetes Technol Ther. 2023;25(9):612-21. DOI:10.1089/dia.2023.0178
41. Costa C, Linhares MI, Bastos F, et al. Effect of ultra-rapid insulin aspart on glycemic control in children with type 1 diabetes: the experience of a Portuguese tertiary centre. Diabetol Int. 2022;13(3):531-3. DOI:10.1007/s13340-021-00565-8
42. Wong EY, Kroon L. Ultra-Rapid-Acting Insulins: How Fast Is Really Needed? Clin Diabetes. 2021;39(4):415-23. DOI:10.2337/cd20-0119
43. Ghosh A. Efficacy and Safety of Faster Aspart in Comparison to Insulin Aspart Among Indian Women with Gestational Diabetes. Curr Diabetes Rev. 2023;19(8):e221222212124. DOI:10.2174/1573399819666221222154443
44. Nørgaard SK, Søholm JC, Mathiesen ER, et al. Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023;11(11):811-21. DOI:10.1016/S2213-8587(23)00236-X
________________________________________________
2. Demidova TY, Titova VV. Insulin therapy is a personalized approach to glycemic management in diabetes. Terapevticheskii Arkhiv (Ter. Arkh.). 2021;92(12):201-6 (in Russian). DOI:10.26442/00403660.2020.12.200449
3. Chen G, Yu J, Gu Z. Glucose-Responsive Microneedle Patches for Diabetes Treatment. J Diabetes Sci Technol. 2019;13(1):41-8. DOI:10.1177/1932296818778607
4. Evans M, Wilkinson M, Giannpolou A. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin. Diabetes Ther. 2019;10(5):1793-800. DOI:10.1007/s13300-019-00685-0
5. Kurtzhals P, Nishimura E, Haahr H, et al. Commemorating insulin's centennial: engineering insulin pharmacology towards physiology. Trends Pharmacol Sci. 2021;42(8):620-39. DOI:10.1016/j.tips.2021.05.005
6. Demidova TY, Izmaylova MY. Fast-acting insulin aspart – from insulin portraits to patient portraits. Meditsinskiy sovet = Medical Council. 2021;(7):8-16 (in Russian. DOI:10.21518/2079-701x-2021-7-8-16
7. Heise T, Stender-Petersen K, Hövelmann U, et al. Pharmacokinetic and Pharmacodynamic Properties of Faster-Acting Insulin Aspart versus Insulin Aspart Across a Clinically Relevant Dose Range in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2017;56(6):649-60. DOI:10.1007/s40262-016-0473-5
8. Heise T, Linnebjerg H, Coutant D, et al. Ultra rapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study. Diabetes Obes Metab. 2020;22(10):1789-878. DOI:10.1111/dom.14094
9. Leohr J, Dellva MA, LaBell E, et al. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020;42(9):1762-77.e4. DOI:10.1016/j.clinthera.2020.07.005
10. Kazda C, Leohr J, Liu R, et al. Ultra rapid lispro (URLi) shows accelerated pharmacokinetics and greater reduction in postprandial glucose versus Humalog® in patients with type 1 diabetes mellitus in a randomized, double-blind meal test early-phase study. Diabetes Obes Metab. 2022;24(2):196-203. DOI:10.1111/dom.14563
11. Leohr J, Kazda C, Liu R, et al. Ultra-rapid lispro shows faster pharmacokinetics and reduces postprandial glucose excursions versus Humalog® in patients with type 2 diabetes mellitus in a randomized, controlled crossover meal test early phase study. Diabetes Obes Metab. 2022;24(2):187-95. DOI:10.1111/dom.14561
12. Suplotova LA, Tilkiyan AS. Ultrafast-acting insulin: pharmacological properties and their impact on clinical aspects. Meditsinskiy sovet = Medical Council. 2024;(13):146-54 (in Russian). DOI:10.21518/ms2024-262
13. Heise T, Pieber TR, Danne T, et al. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017;56(5):551-5. DOI:10.1007/s40262-017-0514-8
14. Kazda CM, Leohr J, Liu R, et al. Ultra-rapid Lispro (URLi) Shows Faster Absorption of Insulin Lispro vs. Humalog® during Insulin Pump (CSII) Use in Patients with T1D. Diabetes. 2018;67(Suppl. 1). DOI:10.2337/db18-1006-p
15. Russell-Jones D, Bode BW, De Block C, et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017;40(7):943-50. DOI:10.2337/dc16-1771
16. Mathieu C, Bode BW, Franek E, et al. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018;20(5):1148-215. DOI:10.1111/dom.13205
17. Bowering K, Case C, Harvey J, et al. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The ONSET 2 Trial. Diabetes Care. 2017;40(7):951-5. DOI:10.2337/dc16-1770
18. Malecki MT, Cao D, Liu R, et al. Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy. Diabetes Technol Ther. 2020;22(11):853-60. DOI:10.1089/dia.2020.0129
19. Zhang Q, Chigutsa F, Chang AM. Efficacy and Safety of Ultra-Rapid Lispro in Younger and Older Patients with Type 2 Diabetes: Randomized Double-Blind PRONTO-T2D Study. Diabetes Ther. 2022;13(8):1547-57. DOI:10.1007/s13300-022-01290-4
20. Danne T, Axel Schweitzer M, Keuthage W, et al. Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study. Diabetes Technol Ther. 2021;23(3):203-12. DOI:10.1089/dia.2020.0360
21. Pal R, Banerjee M, Bhadada SK. Glycaemic efficacy and safety of mealtime faster-acting insulin aspart administered by injection as compared to insulin aspart in people with diabetes mellitus: A meta-analysis of randomized controlled trials. Diabet Med. 2021;38(3):e14515. DOI:10.1111/dme.14515
22. Madsbad S. Impact of postprandial glucose control on diabetes-related complications: How is the evidence evolving? J Diabetes Complications. 2016;30(2):374-85. DOI:10.1016/j.jdiacomp.2015.09.019
23. Riddle MC. Basal Glucose Can Be Controlled, but the Prandial Problem Persists – It's the Next Target! Diabetes Care. 2017;40(3):291-300. DOI:10.2337/dc16-2380
24. Lefever E, Vliebergh J, Mathieu C. Improving the treatment of patients with diabetes using insulin analogues: current findings and future directions. Expert Opin Drug Saf. 2021;20(2):155-69. DOI:10.1080/14740338.2021.1856813
25. Mannucci E, Monami M, Lamanna C, Adalsteinsson JE. Post-prandial glucose and diabetic complications: systematic review of observational studies. Acta Diabetol. 2012;49(4):307-14. DOI:10.1007/s00592-011-0355-0
26. Heise T, Piras de Oliveira C, Juneja R, et al. What is the value of faster acting prandial insulin? Focus on ultra rapid lispro. Diabetes Obes Metab. 2022;24(9):1689-701. DOI:10.1111/dom.14773
27. Klonoff DC, Evans ML, Lane W, et al. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019;21(4):961-6. DOI:10.1111/dom.13610
28. Warren M, Bode B, Cho JI, et al. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes Obes Metab. 2021;23(7):1552-51. DOI:10.1111/dom.14368
29. Bode B, Carlson A, Liu R, et al. Ultrarapid Lispro Demonstrates Similar Time in Target Range to Lispro with a Hybrid Closed-Loop System. Diabetes Technol Ther. 2021;23(12):828-36. DOI:10.1089/dia.2021.0184
30. Ware J, Allen JM, Boughton CK, et al. Hybrid Closed-Loop with Faster Insulin Aspart Compared with Standard Insulin Aspart in Very Young Children with Type 1 Diabetes: A Double-Blind, Multicenter, Randomized, Crossover Study. Diabetes Technol Ther. 2023;25(6):431-3. DOI:10.1089/dia.2023.0042
31. Hsu L, Buckingham B, Basina M, et al. Fast-Acting Insulin Aspart Use with the MiniMed(TM) 670G System. Diabetes Technol Ther. 2021;23(1):1-7. DOI:10.1089/dia.2020.0083
32. Nwokolo M, Lakshman R, Hartnell S, et al. CamAPS FX Hybrid Closed-Loop with Ultra-Rapid Lispro Compared with Standard Lispro in Adults with Type 1 Diabetes: A Double-Blind, Randomized, Crossover Study. Diabetes Technol Ther. 2023;25(12):856-63. DOI:10.1089/dia.2023.0262
33. Ozer K, Cooper AM, Ahn LP, et al. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021;23(4):286-92. DOI:10.1089/dia.2020.0500
34. Boughton CK, Hartnell S, Thabit H, et al. Hybrid closed-loop glucose control with faster insulin aspart compared with standard insulin aspart in adults with type 1 diabetes: A double-blind, multicentre, multinational, randomized, crossover study. Diabetes Obes Metab. 2021;23(6):1389-436. DOI:10.1111/dom.14355
35. Dovc K, Piona C, Yeşiltepe Mutlu G, et al. Faster Compared With Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial. Diabetes Care. 2020;43(1):29-36. DOI:10.2337/dc19-0895
36. Bode BW, Iotova V, Kovarenko M, et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The ONSET 7 Trial. Diabetes Care. 2019;42(7):1255-22. DOI:10.2337/dc19-0009
37. Wadwa RP, Laffel LM, Franco DR, et al. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial. Diabetes Obes Metab. 2023;25(1):89-97. DOI:10.1111/dom.14849
38. Cengiz E, Danne T, Ahmad T, et al. ISPAD Clinical Practice Consensus Guidelines 2022: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2022;23(8):1277-26. DOI:10.1111/pedi.13442
39. González de Buitrago Amigo J, González García A, Díaz Fernández P, et al. The impact of "faster aspart" on blood glucose control in children and adolescents with type 1 diabetes treated using a sensor-augmented insulin pump. An Pediatr (Engl Ed). 2021;95(5):321-2. DOI:10.1016/j.anpede.2020.11.006
40. Dovc K, Bergford S, Fröhlich-Reiterer E, et al. A Comparison of Faster Insulin Aspart with Standard Insulin Aspart Using Hybrid Automated Insulin Delivery System in Active Children and Adolescents with Type 1 Diabetes: A Randomized Double-Blind Crossover Trial. Diabetes Technol Ther. 2023;25(9):612-21. DOI:10.1089/dia.2023.0178
41. Costa C, Linhares MI, Bastos F, et al. Effect of ultra-rapid insulin aspart on glycemic control in children with type 1 diabetes: the experience of a Portuguese tertiary centre. Diabetol Int. 2022;13(3):531-3. DOI:10.1007/s13340-021-00565-8
42. Wong EY, Kroon L. Ultra-Rapid-Acting Insulins: How Fast Is Really Needed? Clin Diabetes. 2021;39(4):415-23. DOI:10.2337/cd20-0119
43. Ghosh A. Efficacy and Safety of Faster Aspart in Comparison to Insulin Aspart Among Indian Women with Gestational Diabetes. Curr Diabetes Rev. 2023;19(8):e221222212124. DOI:10.2174/1573399819666221222154443
44. Nørgaard SK, Søholm JC, Mathiesen ER, et al. Faster-acting insulin aspart versus insulin aspart in the treatment of type 1 or type 2 diabetes during pregnancy and post-delivery (CopenFast): an open-label, single-centre, randomised controlled trial. Lancet Diabetes Endocrinol. 2023;11(11):811-21. DOI:10.1016/S2213-8587(23)00236-X
Авторы
Т.Ю. Демидова, В.В. Титова*
ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России (Пироговский Университет), Москва, Россия
*meteora-vica@mail.ru
Pirogov Russian National Research Medical University (Pirogov University), Moscow, Russia
*meteora-vica@mail.ru
ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России (Пироговский Университет), Москва, Россия
*meteora-vica@mail.ru
________________________________________________
Pirogov Russian National Research Medical University (Pirogov University), Moscow, Russia
*meteora-vica@mail.ru
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