Insulin detemir and its place in the diabetes treatment: results of 15-year use


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Abstract

Insulin detemir (Levemir) is a long-acting basal insulin analogue for the treatment of patients with type 1 and type 2 diabetes mellitus (DM1, DM2). The prolonged effect of insulin detemir is associated with its high ability to self-association and the possibility of a reversible connection with albumin in both subcutaneous fat and plasma, which slows down its systemic absorption from the injection sites and provides a buffering effect and low variability of action. Numerous randomized, open, multi-center studies have shown the positive effect of insulin detemir on glycemic control using this basal insulin analogue in combination with oral hypoglycemic therapy and in baseline bolus therapy for DM1 and DM2 patients. Compared with neutral protamine Hagedorn (NPH) insulin or insulin glargine, insulin detemir showed similar effectiveness according to the glycated hemoglobin (HbA1c) level, with a lower variability, which determined a significantly lower risk of developing hypoglycemic episodes, including nocturnal hypoglycemia in DM1 and DM2 patients. An additional advantage of insulin detemir was significantly lower patient weight gain compared with NPH insulin and insulin glargine. The results of studies of patients aged 2-16 or 6-17 years have shown that the inclusion of insulin detemir in the baseline-bolus mode of insulin therapy for children and adolescents is more effective and safe compared to NPH insulin and insulin glargine. Positive results were demonstrated in pregnant women with DM1. Maternal and neonatal outcomes on insulin detemir therapy were similar to the outcomes observed with NPH insulin treatment in terms of their effectiveness, but with a lower incidence of hypoglycemic conditions, which determines the greater safety of this drug. Insulin detemir has proved its worth as basal insulin therapy in older DM1 and DM2 patients with comorbid pathology. Thus, insulin detemir may become the best option for use as a basal insulin therapy and as a part of the basis-bolus insulin therapy of DM1 and DM2 patients of different age groups.

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About the authors

Yana V. Girsh

Surgut State University of the Khanty-Mansiysk Autonomous Okrug - Yugra

Email: yanaef@yandex.ru
Medical Institute, MD, Professor Surgut, Russia

References

  1. Bliss M. The history of insulin. Diabet Care. 1993;16(Suppl. 3):4-7. URL: http://www.ncbi. nlm.nih.gov/pubmed/8299476.
  2. Bliss M. The discovery of insulin: the inside story. Publ Am Inst Hist Pharm. 1997;16:93-9. URL: http:// www.ncbi.nlm.nih.gov/pubmed/11619903.
  3. Karamitsos D.T. The story of insulin discovery. Diabet Res Clin Pract. 2011;93(Suppl. 1):2-8. doi: 10.1016/S0168-8227(11)70007-9.
  4. Brange J., Owens D.R., Kang S., Volund A. Monomeric insulins and their experimental and clinical implications. Diabet Care.1900;13(9): 923-54.
  5. Owens D.R., Coates FIA., Luzio S.D., et al. Pharmacokinetics of 125 I-labelled insulin glargine (HOE 901) in healthy men. Comparison with NPH insulin and the influence of different subcutaneous injection sites. Diabet Care. 2000;23(6):813-19.
  6. Home P Insulin glargine: the first clinically useful extendedacting insulin in half a century. Exp Opin Invest Drugs. 1999;8:307-14.
  7. Diabetes Control and Complications Trial (DCCT): Results of Feasibility Study. The DCCT Research Group: https://doi.org/10.2337/diacare.10.1.1
  8. Turner R., et al. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes. Lancet. 1998. 352(9131):837-53.
  9. Khunti K., Alsifri S., Aronson R., et al. Po118 self-reported hypoglycemia: a global study of 24 countries with 27,585 insulintreated patients with diabetes: the hat study. Diabet Res Clin Pract. 2014;106:105-6. doi: 10.1016/S0168-8227(14)70412-7.
  10. Kurtzhals P. Pharmacology of insulin detemir Endocrinol Metab Clin North Am. 2007; 36(Suppl. 1):14-20.
  11. Markussen J., Havelund S., Kurtzhals P, et al. Soluble, fatty acid acylated insulins bind to albumin and show protracted action in pigs. Diabetol. 1996;39(3):281-88.
  12. Hamilton-Wessler M., Ader M., Dea M., et al. Mechanism of protracted metabolic effects of fatty acid acylated insulin, NN304, in dogs: retention of NN304 by albumin. Diabetol. 1999;42(10):1254-63
  13. Meneghini L., Coenen C., Rojas P, Selam J.L. Терапия инсулином детемир обеспечивает улучшение гликемического контроля, снижая при этом риск гипогликемий и массу тела пациентов, получавших предшествующую терапию инсулином гларгин или инсулином НПХ., ADA 2007 июнь; Абстракт 2258. [Meneghini L., Coenen C., Rojas P, Seiam J.L. Insulin detemir therapy provides improved glycemic control while reducing the risk of hypoglycemia and body weight in patients who received previous insulin therapy with glargine or NPH insulin., ADA 2007 June; Abstract 2258].
  14. Sreenan S., Landstedt-Hallin L., Coenen C., Trippe B. Старт инсулинотерапии с инсулина детемир у пациентов с СД 2 типа, получавших ПССП, обеспечивает достоверное снижение массы тела, при отмене ПСМ и ТЗД: Результаты исследования PREDICTIVE™, ADA 2007 июнь; Абстракт 5492007. [Sreenan S., Landstedt-Hallin L., Coenen C., Trippe B. The start of insulin therapy with insulin detemir in patients with type 2 diabetes who received PSSp provides a significant reduction in body weight, with the abolition of PSM and TZD: Results of the study PREDICTIVE ™, ADA June 2007; Abstraction 5492007].
  15. Selam J.L., Koenen C., Weng W., Meneghini L. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin na-ïve patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008;24:1:11-20.
  16. Lanstedt-Hallin L., Sreenan S., Coenen C., King A. Перевод с инсулина гларгин в качестве базального компонента базис-болюсной терапии на терапию инсулином детемир улучшает гликемический контроль и снижает частоту гипогликемий без повышения массы тела у пациентов с СД 2 типа: 6-месячные результаты исследования PREDICTIVE™. ADA 2007 июнь; Абстракт 22582007. [Lanstedt-Hallin L., Sreenan S., Coenen C., King A. Translating insulin glargine as a basal component of base-bolus therapy to insulin therapy detemir improves glycemic control and reduces the incidence of hypoglycemia without weight gain in patients with type 2 diabetes: 6-month results of the PREDICTIVE ™ study. ADA 2007 June; Abstract 22582007].
  17. Home P., Bartley P., Russell-Jones D., et al. Study to Evaluate the Administration of Detemir Insulin Efficacy, Safety and Suitability (STEADINESS) Study Group. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabet Care. 2004;27:1081-87.
  18. Vague P, Selam J.L., Skeie S., et al. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care. 2003:26.590-96.
  19. Rostami P., Setoodeh A., Rabbani A., et al. A randomized clinical trial of insulin glargine and aspart, compared to NPH and regular insulin in children with Type 1 diabetes mellitus. Iran J Pediatr. 2014;24:173- 78.
  20. Lindholm A. New insulins in the treatment of diabetes mellitus. Best Pract Res Clin Gastroenterol. 2002;16:475-92.
  21. Havelund S., Plum A., Ribel U., et al. The Mechanism of Protraction of Insulin Detemir, a Long-acting, Acylated Anal Hum Ins Pharmaceutical Res. 2004;21(8).
  22. Davies M.J., Derezinski T, Pedersen C.B., Clauson P Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabet Technol Ther 2008;10:4:273-77.
  23. Plank J., Bodenlenz M., Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabet Care. 2005;28(5):1107-212.
  24. Bott S., Tusek C., Jacobsen L.V, et al. Insulin detemir under steady-state conditions: no accumulation and constant metabolic effect over time with twice daily administration in subjects with type 1 diabetes. Diabet Med. 2006;23(5):522-28.
  25. Kurtzhals P. Engineering predictability and protraction in a basal insulin analogue: the pharmacology of insulin detemir. Int J Obes. 2004;28(Suppl. 2):23-8.
  26. Ganiats T. Variability in Insulin Action: Mechanisms, Implications, and Recent Advances. Internet J Family Practice. 2006;5(2).
  27. Louis B. Chaykin Insulin Detemir and Its Unique Mechanism of Action. Internet J Endocrinol. 2007;4(1). URL: http://www.ispub.com/ostia/ index.php?xmlFilePath=journals/ijen/vol4n1/ insulin.xml (1 of 14).
  28. Heise T., Nosek L., Biilmann B.R., et al. Lower Within-Subject Variability of Insulin Detemir in Comparison to NPH Insulin and Insulin Glargine in People With Type 1. Diabet. 2004;53;1614-20.
  29. Garber A., Olsen K., Draeger E. Treatment with insulin detemir provides improved glycemic control and less weight gain compared to NPH insulin in people with diabetes. American Diabetes Association. 64th Scientific Sessions [abstract №. 527-P plus poster]. Diabetes 2004;54(Suppl.2):A125.
  30. Hendriksen K.V., Jensen T., Oturai P., Feldt-Rasmussen B. Effects of insulin detemir and NPH insulin on renal handling of sodium, fluid retention and weight in type 2 diabetic patients. Diabetologia. 2012;55:1:46-50.
  31. Heller SюR. Insulin analogues. Curr Med Res Opin. 2002;18(Suppl. 1):S40-7.
  32. Mathiesen E.R., Hod M., Ivanisevic M., et al. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabet Care. 2012;35(10):2012-17.
  33. Hod M., McCance D.R., Ivanisevic M., et al. Perinatal outcomes in a randomized trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. 71st Ann Sci Sess Am Diabet Ass. 2011 Jun 24-28; San Diego.
  34. Moshe H., Elisabeth R., Mathiesen L., et al. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med. 2014;27(1):7-13. doi: 10.3109/14767058.2013.79.
  35. Mathiesen E.R., Kinsley B., Amiel S.A., et al. Insulin Aspart Pregnancy Study Group. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabet Care. 2007;30:771-76.
  36. Hod M., Damm P, Kaaja R., et al. Insulin Aspart Pregnancy Study Group. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol. 2008;198:186.e1-7.
  37. Robertson K., et al. Insulin detemir compared with NPH insulin in children and adolescents with type 1 diabetes. Diabet Med. 2007;24:27-34.
  38. Davies J.M., Gross J.L., Ono Y., et al. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, openlabel, treat-to-target non-inferiority trial. Diabetes. Obes Metab. 2014:16:922-30.
  39. Thalange N., Bereket A., Larsen J., et al. Insulin analogues in children with type 1 diabetes: A 52-week randomized clinical trial. Diabet Med. 2013;30:216-25.
  40. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus. N Engl J Med. 1993:329:979-86.
  41. Thalange N., Bereket A., Larsen J., et al. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabet. 2011;12(7):632-41.
  42. Thalange N.K.S., Bereket A., Larsen J., et al. Comparison of insulin detemir and NPH insulin in children and adolescents (2-16 years) with T1DM: a 52-week randomized clinical trial [abstract no. 1784-P]. 69th. Ann Meet Am Diabet Ass. 2009 Jun 5-9; New Orleans.
  43. Halvorson M., Yasuda P, Carpenter S., Kaiserman K. Unique challenges for paediatric patients with diabetes. Diabetes Spectr. 2005:18:67-173.
  44. Rewers MJ, Pillay K., de Beaufort C. ISPAD Clinical Practice Consensus Guidelines 2014 Compendium. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes.2014:15(Suppl. 20):102-14.
  45. Malek R., Gonzalez-Galvez G., Naggar N., et al. Safety and Effectiveness of Insulin Detemir in Different Age-Groups in the A1 chieve Study. Diabet Ther. 2013;4:77-90. Doi 10.1007/ s13300-013-0021-3.
  46. Karnieli E., Florian M., Baeres M., et all. Observational Study of Once-Daily Insulin Detemir in People with Type 2 Diabetes Aged 75 Years or Older. A Sub-Analysis of Data from the Study of Once-Daily Levemir (SOLVE). Drugs Aging. 2013;30(3):167-75.
  47. Holstein A., Hammer C., Hahn M., et al. Severe sulfonylurea-induced hypoglycemia: a problem of uncritical prescription and deficiencies of diabetes care in geriatric patients. Expert Opin Drug Saf. 2010;9:675-81.
  48. Mooradian A.D. Special considerations with insulin therapy in older adults with diabetes mellitus. Drugs Aging. 2011;28:429-38.

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