References

diaendo

Сахарный диабет

Diabetes mellitus

2072-03512072-0378

Endocrinology research centre

10.14341/DM20134101-107

diaendo-6279

Research Article

Диагностика, контроль, лечение

Diagnosis, control, treatment

Десять лет применения в мире и в России инсулина НовоМикс 30

Ten years of NovoMix 30 in Russian and international clinical practice

Суркова

Елена Викторовна

Surkova

Elena Viktorovna

доктор медицинских наук, ведущий научный сотрудник отделения программного обучения и лечения

MD, PhD, Leading Researcher in the Diabetic education and treatment department

elenasurkova@mail.ru

ФГБУ Эндокринологический научный центр, МоскваРоссияEndocrinology Research Centre, MoscowRussian Federation

2013

18122013

164101107

2013

Суркова Е.В.

Surkova E.V.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.dia-endojournals.ru/jour/article/view/6279

Инсулинотерапия сахарного диабета 2 типа представляет большую проблему лечения людей пожилого и старческого возраста. Возможность использования комбинированных (двухфазных) инсулинов облегчает эту задачу, повышает комплаетность больных и приводит к достижению целевых показателей углеводного обмена.

Insulin treatment for type 2 diabetes mellitus is challenging in elderly people. Biphasic insulin preparations technically simplify this task, but also increase compliance and facilitate the achievement of therapeutic goals.

двухфазные препараты инсулинабазис-болюсный режимцелевые значения гликемии

biphasic insulinbasal bolus dosingglycemic target

References1

Heinemann L. Do insulin-treated diabetic patients use an injection-meal-interval in daily life? Diabet Med. Diabet Med. 1995;12(5):449–45.

DOI: 10.1111/j.1464-5491.1995.tb00514.x

Overmann H, Heinemann L. Injection-meal interval: recommendations of diabetologists and how patients handle it. Diabetes Res Clin Pract. 1999;43(2):137–142.

DOI: 10.1016/S0168-8227(98)00132-6

Jacobsen LV, Søgaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000;56(5):399–403.

DOI: 10.1007/s002280000159

McSorley KM, Bell PM, Jacobsen LV, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double blind cross-over study in adults with type 2 diabetes mellitus. Clinical Therapeutics. 2002;24(4):530–539.

DOI: 10.1016/S0149-2918(02)85129-3

McNally PG, Dean JD, Morris D, Wilkinson PD, Compion G, Heller SR. Used continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care. 2007;30(5):1044–1048.

DOI: 10.2337/dc06-1328

Rizvi AA, Lightelm RJ. The use of premixed insulin analogs in the treatment of patients with type 2 diabetes mellitus: advantages and limitations. Insulin 2007;2(2):68–79

DOI: 10.1016/S1557-0843(07)80018-2

Boehm, B. Home P.D., Kamp B.N.M., Behrend C., Kamp NM, Lindhoolm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients. Diabet Med 2002;19(5):393–399.

DOI: 10.1046/j.1464-5491.2002.00733.x.

Boehm BO, Vaz JA, Brøndsted L, Home PD. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. European Journal of Internal Medicine. 2004;15(8):496–502.

DOI: 10.1016/j.ejim.2004.10.001

Weyer C, HeiseT, Heinemann L. Insulin aspart in 30/70 premixed formulation: pharmacodynamic propertis of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997;20(10):1612–1614.

DOI: 10.2337/diacare.20.10.1612

Qayym R, Wilson LM, Bolen S, Maruthur N, Marinopoulos SS, Feldman L, Ranasinghe P, Amer M, Bass EB. Comparative effectiveness, safety and indication of insulin analogues in premixed formulations for adults with type 2 diabetes. Rockville (MD): Agency for healthcare research and quality; 2008 (Comparative effectiveness reviews № 14)

Davidson JA, Liebl A, Christiansen JS, Fulcher G, Ligthelm RJ, Brown P, et al. Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: A meta-analysis. Clinical Therapeutics 2009;31(8):1641–1651.

DOI: 10.1016/j.clinthera.2009.08.011

Niskanen L. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clinical Therapeutics. 2004;26(4):531–540.

DOI: 10.1016/S0149-2918(04)90055-0

Hermansen K, Colombo M, Storgaard H, Ostergaard A, Kolendorf K, Madsbad S. Improved Postprandial Glycemic Control With Biphasic Insulin Aspart Relative to Biphasic Insulin Lispro and Biphasic Human Insulin in Patients With Type 2 Diabetes. Diabetes Care 2002;25(5):883–888.

DOI: 10.2337/diacare.25.5.883

Farcasiu E, Ivanyi T, Mozejko-Pastewka B, Birkus Z, Csog J, Kowalska I, et al. Efficacy and safety of prandial premixed therapy using insulin lispro mix 50/50 3 times daily compared with progressive titration of insulin lispro mix 75/25 or biphasic insulin aspart 70/30 twice daily in patients with type 2 diabetes mellitus: a randomized, 16-week, open-label study. Clinical Theraputics. 2011;33(11):1682–1693.

DOI: 10.1016/j.clinthera.2011.10.001

Chen JW, Lauritzen T, Bojesen A, Christiansen JS. Multiple mealtime administration of biphasic insulin aspart 30 versus traditional basal-bolus human insulin treatment in patients with type 1 diabetes. Diabetes Obes Metab. 2006;8(6):682–689.

DOI: 10.1111/j.1463-1326.2005.00557.x

Strojek K, Bebakar WMW, Khutsoane DT, Pesic M, Šmahelová A, Thomsen HF, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009;25(12):2887–2894.

DOI: 10.1185/03007990903354674

Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, et al. Initiating Insulin Therapy in Type 2 Diabetes: A comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28(2):260–265.

DOI: 10.2337/diacare.28.2.260

Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1–2–3 study. Diabetes Obes Metab 2006;8(1):58–66.

DOI: 10.1111/j.1463-1326.2005.00563.x

Hosoi Y, Ohtani K, Shimizu H, Kashima K, Sato N, Akiyama H, et al. Attainment of glycaemic goals by step-up therapy with biphasic insulin aspart-70/30 in Japanese type 2 diabetic patients. Endocr J. 2011;58(2):131–135.

DOI: 10.1507/endocrj.K10E-307

Yoshioka N, Kurihara Y, Manda N, Komori K, Kato M, Kijima H, et al. Step-up therapy with biphasic insulin aspart-70/30-Sapporo 1–2–3 study. Diabetes Research and Clinical Practice. 2009;85(1):47–52.

DOI: 10.1016/j.diabres.2009.04.012

Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix® 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study. International Journal of Clinical Practice. 2009;63(3):522–531.

DOI: 10.1111/j.1742-1241.2009.02002.x

Kawamori R, Valensi P. IMPROVE™ observational study of biphasic insulin aspart 30/70 in patients with Type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2010;5(4):507–516.

DOI: 10.1586/eem.10.31

Шестакова МВ. Наблюдательная программа IMPROVETM – безопасность и эффективность двухфазного инсулина аспарт 30 в рутинной клинической практике. Обзор исходных характеристик российской когорты пациентов. Сахарный диабет. 2009;(4):93–97. [Shestakova M, Ballan A. IMPROVE™ observational program: safety and effectiveness of biphasic insulin aspart 30 in routine clinical practice.Overview of starting characteristics of the Russian patient cohort. Diabetes mellitus. 2009;(4):93–97.

DOI: 10.14341/2072-0351-5713 ].

Шестакова МВ. Терапия двухфазным инсулином аспарт 30/7 (НовоМикс 30) улучшает гликемический контроль у пациентов с сахарным диабетом 2 типа: данные российской когорты пациентов наблюдательной программы IMPROVETM – программы по изучению безопасности и эффективности двухфазного инсулина аспарт 30 в рутинной клинической практике. Сахарный диабет. 2010; (1): 92–100. [Shestakova M, Ballan A. Therapy with biphasic insulin aspart 30/70 (NovoMix 30) improves glycemic control in patients with type 2 diabetes mellitus: resultsfrom a Russian cohort of IMPROVE observational program designed to study safety and efficiency of biphasic insulin aspart 30 inroutine clinical practice. Diabetes mellitus. 2010;(1):92–100.

DOI: 10.14341/2072-0351-6023 ].

Liebl A, Prusty V, Valensi P, Kawamori R, Christiansen JS, Palmer AJ, et al. Ten years of experience with biphasic insulin aspart 30. From drug development to the latest clinical findings. Drugs. 2012;72(11):1495–1520.

DOI: 10.2165/11635490-000000000-00000

Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, et al. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab. 2008;10(3):212–222.

DOI: 10.1111/j.1463-1326.2007.00826.x

Sharma SK, Al-Mustafa M, Oh SJ, Azar ST, Shestakova M, Guler S, et al. Biphasic insulin aspart 30 treatment in patients with type 2 diabetes poorly controlled on prior diabetes treatment: results from the PRESENT study. Current Medical Research and Opinion. 2008;24(3):645–652.

DOI: 10.1185/030079908X260952

Güler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, et al. Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results. Arch Drug Inf. 2009;2(2):23–33.

DOI: 10.1111/j.1753-5174.2008.00015.x

Jang HC, Guler S, Shestakova M. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. International Journal of Clinical Practice. 2008 мая;62(7):1013–1018.

DOI: 10.1111/j.1742-1241.2008.01792.x

Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, et al. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007;23(12):3209–3214.

DOI: 10.1185/030079907X253636

Шестакова МВ. Эффективность и безопасность терапии аналогами инсулина у ранее не получавших инсулин пациентов с сахарным диабетом 2 типа в повседневной клинической практике: результаты многоцентрового наблюдательного 52-недельного исследования A1chive. Сахарный диабет 2012; (4): 115–121. [Shestakova M. Efficacy and safety of treatment with human insulin analogues in daily management of insulin naive patientswith type 2 diabetes mellitus: results of multicenter 52-week observational study A1chive. Diabetes mellitus. 2012;(4):115–121.

DOI: 10.14341/2072-0351-5548 ].

Ligthelm RJ. Self-titration of biphasic insulin aspart 30/70 improves glycaemic control and allows easy intensification in a Dutch clinical practice. Primary Care Diabetes. 2009;3(2):97–102.

DOI: 10.1016/j.pcd.2009.01.003

Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu P, et al. A1c Control in a Primary Care Setting: Self-titrating an Insulin Analog Pre-mix (INITIATEplus Trial. The American Journal of Medicine 2009;122(11):1043–1049.

DOI: 10.1016/j.amjmed.2008.12.026

Shah DR, Hux JE, Laupacis A, Zinman B, van Walraven CR, Hux JE, Laupacis A, Zinman B, van Walraven C. Clinical Inertia in Response to Inadequate Glycemic Control. Do specialists differ from primary care physicians. Diabetes Care. 2005;28(3):600–606.

DOI: 10.2337/diacare.28.3.600

Karter AJ, Subramanian U, Saha C, Crosson JC, Parker MM, Swain BE, et al. Barriers to Insulin Initiation: The Translating Research Into Action for Diabetes Insulin Starts Project. Diabetes Care. 2010;33(4):733–735.

DOI: 10.2337/dc09-1184

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