Clinical characteristics and practical aspects of the use of new basal insulin glargine 300 U/ml Toujeo SoloStar®


如何引用文章

全文:

开放存取 开放存取
受限制的访问 ##reader.subscriptionAccessGranted##
受限制的访问 订阅或者付费存取

详细

The review is dedicated to the analysis of the results of clinical studies on therapeutic comparability of insulin glargine 100 U/ml and 300 U/ml. It is noted that insulin glargine 300 U/mL provides a longer and smoother absorption and duration of action (up to 36 hours regardless of the dose) compared to insulin glargine 100 U/mL. The results confirming the possibility of flexible regimen of dosage of insulin glargine 300 U/ml are presented; this regimen provides similar to fixed dosage regimen the changes in HbA1c and fasting plasma glucose levels, as well as the episodes of nocturnal hypoglycaemia and hypoglycaemia at any time of the day. It is concluded that the use of new basal insulin 300 U/mL opens up new opportunities for the modern adequate treatment of patients with diabetes mellitus.

全文:

受限制的访问

作者简介

M. Antsiferov

SBHCI “Endocrinologicla Dispensary" of Moscow Healthcare Department

MD, Prof., Chief Physician

参考

  1. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Изд. 7-е. / Под ред. И.И. Дедова, М.В. Шестаковой. Сахарный диабет. 2015;18(1S):1-112.
  2. Standards of Medical Care in Diabetes-2015 Abridged for Primary Care Providers. Clin. Diabetes. 2015;33:97-111.
  3. Inzucchi S.E., Bergenstal R.M., Buse J.B., et al. Management of Hyperglycemia in Type 2 Diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140-49.
  4. Stratton I.M., Adler A.I., Neil H.A. Matthews D.R., Manley S.E., Cull C.A., Hadden D., Turner R.C., Holman R.R. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-12.
  5. DCCT. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial. JAMA. 1996;276:1409-415.
  6. Turner R.C., Cull C.A., Frighi V., Holman R.R. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281:2005-12.
  7. Holman R.R., Paul S.K., Bethel M.A., Matthews D.R., Neil H.A. 10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes. N. Engl. J. Med. 2008;359:1577-89.
  8. Riddle M.C., Rosenstock J., Gerich J. The treat-to-target trial randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26:3080-86.
  9. Porcellati F., Rossetti P., Busciantella N.R., Marzotti S., Lucidi P., Luzio S., Owens D.R., Bolli G.B., Fanelli C.G. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs Glargine and Detemir at steady state in Type 1 Diabetes a double-blind, randomized, crossover study. Diabetes Care. 2007;30:2447-52.
  10. Abah S., Turan S., Atay Z., Güran T., Haliloğlu B., Bereket A. Higher insulin detemir doses are required for the similar glycemic control: comparison of insulin detemir and glargine in children with type 1 diabetes mellitus. Pediatr. Diabetes. 2015;16:361-66.
  11. Bryant G.A., McDanel D.L., Horner K.E., et al. Evaluation of dosing and clinical outcomes in patients undergoing conversion of insulin glargine to insulin detemir. Pharmacother. J. Hum. Pharmacol. Drug Ther. 2013;33:56-62.
  12. Инструкция по применению лекарственного препарата для медицинского применения Туджео СолоСтар®.
  13. Steinstraesser A., Schmidt R., Bergmann K., Dahmen R., Becker R.H. Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml. Diabetes Obes. Metab. 2014;16:873-76.
  14. Shiramoto M., Eto T., Irie S., Fukuzaki A., Teichert L., Tillner J., Takahashi Y., Koyama M., Dahmen R., Heise T., Becker R.H. Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes. Metab. 2015;17:254-60.
  15. Becker R.H., Dahmen R., Bergmann K., Lehmann A., Jax T., Heise T. New insulin glargine 300 units• mL- 1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units• mL- 1. Diabetes Care. 2015;38:637-43.
  16. Becker R.H.A., Nowotny I., Teichert L., Bergmann K., Kapitza C. Low within-and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes. Metab. 2015;17:261-67.
  17. Bergenstal R.M., et al. Poster presentation at EASD 2014; Abstract 949 Available at: http://www.easdvirtualmeeting.org/ resources/18574 Accessed April 2016.
  18. Home P.D., Bergenstal R.M., Bolli G.B., Ziemen M., Rojeski M., Espinasse M., Riddle M.C. New insulin glargine 300 units/ml versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2015;38: 2217-25.
  19. Riddle M.C., Yki-Järvinen H., Bolli G.B., et al. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes. Metab. 2015;17:835-42.
  20. 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;17:386-94.
  21. Ritzel R., Roussel R., Bolli G.B., Vinet L., Brulle-Wohlhueter C., Glezer S., Yki-Järvinen 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; 17:859-67.
  22. Yki-Järvinen H., Bergenstal R., Ziemen M., Wardecki M., Muehlen-Bartmer I., Boelle E., Riddle M.C. New insulin glargine 300 units/ mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014;37:3235-43.
  23. Riddle M.C., Bolli G.B., Home P.D., Bergenstal R.M., Ziemen M., Muehlen-Bartmer I., Wardecki M., Vinet L., Jeandidier N., Yki-J rvinen H. Efficacy and safety of flexible versus fixed dosing intervals of insulin glargine 300 U/ mL in people with Type 2 Diabetes. Diabetes Technology & Therapeutics. 2016;18(4):252-57.
  24. 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;37:2755-62.
  25. Frier B.M. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab. Res. Rev. 2008;24:87-92.
  26. Twigg S.M., et al. Age, BMI, and diabetes duration: effect on glycemic control and hypoglycemia with insulin glargine 300U/ml in type 2 diabetes. Poster presented at ADA 2015. 1017-P
  27. Pathak R., Schroeder E., Seaquist E., Zeng C., Lafata J.E., Thomas A., Desai J., Waitzfelder B., Nichols G.A., Lawrence J.M., Karter A.J., Steiner J.F., Segal J., O'Connor P.J. Severe Hypoglycemia Requiring Medical Intervention in a Large Cohort of Adults With Diabetes Receiving Care in U.S. Integrated Health Care Delivery Systems: 2005-2011. Diabetes Care. 2016;39:363-70.
  28. Moen M., Zhan M., Hsu V.D., Walker L.D., Einhorn L.M., Seliger S.L., Fink J.C. Frequency of hypoglycemia and its significance in chronic kidney disease. Clin. J. Am. Soc. Nephrol. 2009;4:1121-27.
  29. Escalada J., Halimi S., Senior P., et al. Glycemic control and hypoglycemia benefits with insulin glargine 300 U/mL (Gla-300) extend to people with type 2 diabetes (T2DM) and mild-to-moderate renal impairment. ADA 76th Scientific Sessions (Abstract 69-OR).
  30. Stella P., et al. Abstract at EASD 2015. ePoster, abstract 977. Available from http://www. easdvirtualmeeting.org/resources/older-people-with-type-2-diabetes-glycaemic-control-and-hypoglycaemia-risk-with-new-insulin-glargine-300-u-ml-gla-300--2. Date accessed May 31 2016.
  31. The ORIGIN trial investigators, Gilbert R.E., Mann J.F., Hanefeld M., Spinas G., Bosch J., Yusuf S., Gerstein H.C. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. Diabetologia. 2014;57(7):1325-31.
  32. Lonn E.M., Bosch J., Diaz R., Lopez-Jaramillo P., Ramachandran A., Hâncu N., Hanefeld M., Krum H., Ryden L., Smith S., McQueen M.J., Dyal L., Yusuf S., Gerstein H.C. Effect of Insulin Glargine and n-3FA on Carotid Intima-Media Thickness in People With Dysglycemia at High Risk for Cardiovascular Events: The Glucose Reduction and Atherosclerosis Continuing Evaluation Study (ORIGIN-GRACE). Diabetes Care. 2013;36:2466-74.

补充文件

附件文件
动作
1. JATS XML
下载

版权所有 © Bionika Media, 2016
##common.cookie##