News and perspectives in insulin treatment

Czech version

Authors: Martin Haluzík
Authors‘ workplace: III. interní klinika 1. LF UK a VFN Praha, přednosta prof. MUDr. Štěpán Svačina, DrSc., MBA
Published in: Vnitř Lék 2014; 60(9): 705-711
Category:

Overview

Insulin therapy is a therapeutic cornerstone in patients with type 1 diabetes and also in numerous patients with type 2 diabetes especially with longer history of diabetes. The initiation of insulin therapy in type 2 diabetes patients is often delayed which is at least partially due to suboptimal pharmacokinetic characteristics of available insulins. The development of novel insulins with more favorable characteristics than those of current insulins is therefore still ongoing. The aim of this paper is to review current knowledge of novel insulins that have been recently introduced to the market or are getting close to routine clinical use. We will also focus on the perspectives of insulin therapy in the long-term run including the alternative routes of insulin administration beyond its classical subcutaneous injection treatment.

Key words:
alternative routes of insulin administration – diabetes mellitus – hypoglycemia – insulin – insulin analogues

Sources

1. Škrha J et al. Diabetologie. Galén: Praha 2009. ISBN 978–80–7262–607–6.

2. Inzucchi SE, Bergenstal RM, Buse JB et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach: Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35(6): 1364–1379.

3. Weng J, Li Y, Xu W et al. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet 2008; 371(9626): 1753–1760.

4. Gerstein HC, Bosch J, Dagenais GR et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367(4): 319–328.

5. Holman RR, Paul SK, Bethel MA et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359(15): 1577–1589.

6. Calvert MJ, McManus RJ, Freemantle N. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br J Gen Pract 2007; 57(539): 455–460.

7. Simons WR, Vinod HD, Gerber RA et al. Does rapid transition to insulin therapy in subjects with newly diagnosed type 2 diabetes mellitus benefit glycaemic control and diabetes-related complications? A German population-based study. Exp Clin Endocrinol Diabetes 2006; 114(9): 520–526.

8. Baldeweg SE, Yudkin JS. Implications of the United Kingdom prospective diabetes study. Primary Care 1999; 26(4): 809–827.

9. Haak T, Tiengo A, Draeger E et al. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005; 7(1): 56–64.

10. Yki-Jarvinen H, Dressler A, Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care 2000; 23(8): 1130–1136.

11. Evans M, Schumm-Draeger PM, Vora J et al. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Diabetes Obes Metab 2011; 13(8): 677–684.

12. Zachariah S, Sheldon B, Shojaee-Moradie F et al. Insulin detemir reduces weight gain as a result of reduced food intake in patients with type 1 diabetes. Diabetes Care 2011; 34(7): 1487–1491.

13. Umpierrez GE, Latif K, Stoever J et al. Efficacy of subcutaneous insulin lispro versus continuous intravenous regular insulin for the treatment of patients with diabetic ketoacidosis. Am J Med 2004; 117(5): 291–296.

14. Vigneri P, Frasca F, Sciacca L et al. Diabetes and cancer. Endocr Relat Cancer 2009; 16(4): 1103–1123.

15. Heinemann L, Richter B. Clinical pharmacology of human insulin. Diabetes Care 1993; 16(Suppl 3): S90-S100.

16. Mathieu C. Can we reduce hypoglycaemia with insulin detemir? Int J Obes Relat Metab Disord 2004; 28(Suppl 2): S35-S40.

17. Dunn CJ, Plosker GL, Keating GM et al. Insulin glargine: an updated review of its use in the management of diabetes mellitus. Drugs 2003; 63(16): 1743–1778.

18. Gough SC, Harris S, Woo V et al. Insulin degludec: Overview of a novel ultra long-acting basal insulin. Diabetes Obes Metab 2013; 15(4): 301–309.

19. Jonassen I, Havelund S, Hoeg-Jensen T et al. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res 2012; 29(8): 2104–2114.

20. Heise T, Nosek L, Bottcher SG et al. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 2012; 14(10): 944–950.

21. Birkeland KI, Home PD, Wendisch U et al. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care 2011; 34(3): 661–665.

22. Heller S, Buse J, Fisher M et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379 (9825): 1489–1497.

23. Garber AJ, King AB, Del Prato S et al. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012; 379(9825): 1498–1507.

24. Zinman B, Philis-Tsimikas A, Cariou B et al. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care 2012; 35(12): 2464–2471.

25. Onishi Y, Park SW, Yoo SJ et al. Insulin degludec improves glycemic control in insulin-naive patients with type 2 diabetes: Results of a randomized Pan-Asian trial. Diabetes 2012; 61(Suppl 1): A272.

26. Bergenstal R, Bhargava A, Jain R et al. 200 U/ml insulin degludec improves glycemic control similar to insulin glargine with a low risk of hypoglycemia in insulin-naive people with type 2 diabetes. Abstract presented at American Association of Clinical Endocrinologists 21st Annual Scientific Meeting and Clinical Congress 2012.

27. Birkeland KI, Raz I, Gough S et al. Insulin degludec in a flexible daily dosing regimen provides similar glycaemic control without increasing rates of hypoglycaemia compared to dosing the same time daily in type 2 diabetes. Diabetologia 2011; 54(Suppl 1): S423.

28. Atkin SL, Bain S, Gough S et al. Insulin degludec does not compromise efficacy or safety when given in a flexible once-daily dosing regimen compared to insulin glargine once daily at the same time each day in type 2 diabetes. Diabetologia 2011; 54(Suppl 1): S53.

29. Mathieu C, Hollander P, Miranda-Palma B et al. Insulin degludec allows for flexible daily dosing in type 1 diabetes, providing equal glycemic control with less nocturnal hypoglycemia than insulin glargine over 52 weeks. Diabetes 2012; 61(Suppl 1): A550.

30. Russell-Jones DL, Hollander P, Miranda-Palma B et al. Altering time of day of once-daily dosing of insulin degludec achieves similar glycemic control and safety compared to dosing the same time of day in peoiple with type 1 diabetes. Diabetes 2012; 61(Suppl 1): A91.

31. Ratner RE, Gough S, Mathieu C et al. Prospectively planned meta-analysis comparing hypoglycemia rates of insulin degludec with those of insuline glargine. Diabetes 2012; 61(Suppl 1): A101.

32. Riddle M, Bolli G, Ziemen M et al. New insulin glargine formulation: glucose control and hypoglycemia in people with type 2 diabetes using basal and mealtime insulin (EDITION I). Diabetes 2013; 62(Suppl 1): 43-LB.

33. Tillner J, Bergmann K, Teichert L et al. Euglycemic clamp profile of new insulin glargine U300 formulation in patients with type 1 diabetes (T1DM) is different from glargine U100. Diabetes 2013; 62(Suppl 1): A234.

34. Bergenstal RM, Rosenstock J, Arakaki RF et al. A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care 2012; 35(11): 2140–2147.

35. Rosenstock J, Bergenstal RM, Blevins TC et al. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study. Diabetes Care 2013; 36(3): 522–528.

36. Hill J. New insulin analogues and their impact on diabetes care. Br J Community Nurs 2003; 8(11): 515–518.

37. Heinemann L, Nosek L, Flacke F et al. U-100, pH-Neutral formulation of VIAject((R)) : faster onset of action than insulin lispro in patients with type 1 diabetes. Diabetes Obes Metab 2012; 14(3): 222–227.

38. Hompesch M, Muchmore DB, Morrow L et al. Improved postprandial glycemic control in patients with type 2 diabetes from subcutaneous injection of insulin lispro with hyaluronidase. Diabetes Technol Ther 2012; 14(3): 218–224.

39. Morrow L, Muchmore DB, Ludington EA et al. Reduction in intrasubject variability in the pharmacokinetic response to insulin after subcutaneous co-administration with recombinant human hyaluronidase in healthy volunteers. Diabetes Technol Ther 2011; 13(10): 1039–1045.

40. Farr SJ, McElduff A, Mather LE et al. Pulmonary insulin administration using the AERx system: physiological and physicochemical factors influencing insulin effectiveness in healthy fasting subjects. Diabetes Technol Ther 2000; 2(2): 185–197.

41. Strack TR. Inhaled human insulin. Drugs Today (Barc) 2006; 42(4): 207–221.

42. Aungst BJ, Rogers NJ. Site dependence of absorption-promoting actions of laureth-9, Na salicylate, Na2EDTA, and aprotinin on rectal, nasal, and buccal insulin delivery. Pharm Res 1988; 5(5): 305–308.

43. Wong TW. Design of oral insulin delivery systems. J Drug Target 2010; 18(2): 79–92.

44. Leifke E, Strack TR. Subcutaneous insulin therapy – end of the road after 80 years? Drugs Today (Barc) 2014; 50(2): 181–201.

45. Damge C, Socha M, Ubrich N et al. Poly(epsilon-caprolactone)/eudragit nanoparticles for oral delivery of aspart-insulin in the treatment of diabetes. J Pharm Sci 2010; 99(2): 879–889.

46. Woitiski CB, Neufeld RJ, Veiga F et al. Pharmacological effect of orally delivered insulin facilitated by multilayered stable nanoparticles. Eur J Pharm Sci 2010; 41(3–4): 556–563.

47. Clement S, Dandona P, Still JG et al. Oral modified insulin (HIM2) in patients with type 1 diabetes mellitus: results from a phase I/II clinical trial. Metabolism 2004; 53(1): 54–58.

48. Clement S, Still JG, Kosutic G et al. Oral insulin product hexyl-insulin monoconjugate 2 (HIM2) in type 1 diabetes mellitus: the glucose stabilization effects of HIM2. Diabetes Technol Ther 2002; 4(4): 459–466.