Role and Benef its of Insulin Analogues in the Treatment of Diabetes Mellitus

Abstract

Diabetes mellitus is an increasing health problem in the world and our country. Medical nutrition, diet, exercise, patient education and medical treatment constitute major solution methods for this problem. Insulin has a special place among choices of medical treatment. In this article, insulin analogues in treatment of diabetes mellitus were reviewed. When glycemic control, hypoglycemia side effect and patient compliance to treatment are considered, previous studies have shown that analogue insulins should be preferred to human insulin. Insulin analogues have an important role in medical treatment of diabetes mellitus.

Keywords

• Diabetes mellitus
• human insulin
• analogue insülin

İnsülin Analoglarının Diyabetes Mellitus Tedavisindeki Rolü ve Faydaları

Öz

Diyabetes Mellitus (DM) ülkemizde ve dünyada giderek artan bir sağlık problemidir. Tıbbi beslenme, diyet, egzersiz, hasta eğitimi ve medikal tedavi bu problemin çözüm yöntemleridir. Medikal tedavi seçenekleri içinde insülin tedavisi özel bir yer tutmaktadır. Bu yazıda diyabetes mellitus tedavisinde insülin analogları ele alınmıştır. Glisemik kontrol, hipoglisemi yan etkisi, tedavi uyumu kriter olarak alınırsa, İnsan insülini ile insülin analogları karşılaştırıldığında analog insülinlerin tercih edilmesi gerektiği yapılan çalışmalardan anlaşılmaktadır. İnsülin analogları diyabetes mellitusun medikal tedavisinde önemli bir yere sahiptir.

Anahtar Kelimeler

• Diyabetes Mellitus
• İnsan insülini
• Analog insülin

References

1. 1. United Kingdom Prospective Diabetes Study Group Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet,1998, 352:854–865
2. 2. United Kingdom Prospective Diabetes Study Group Intensive blood-glucose control with sulphonylureas or insülin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet,1998, 352:837–853
3. 3. Ohkubo Y, Kishikawa H, Araki E et al. Intensive insülin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulindependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract, 1995, 28:103–117
4. 4. Stratton IM, Adler AI, Neil HA et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ,2000, 321:405–412
5. 5. Gaede P, Vedel P, Larsen N et al. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med ,2003, 348:383–393
6. 6. Genuth S, Eastman R, Kahn R et al. Implications of the United kingdom prospective diabetes study. Diabetes Care,2003, 26:S28–S32
7. 7. Chiasson JL. Acarbose for the prevention of diabetes, hypertension, and cardiovascular disease in subjects with impaired glucose tolerance: the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial. Endocr Pract,2006, 12:25–30
8. 8. Selvin E, Wattanakit K, Steffes MW, Coresh J, Sharrett AR. HbA1c and peripheral arterial disease in diabetes: the atherosclerosis risk in communities study. Diabetes Care,2006, 29:877–882

9. 9. Kirkman MS, McCarren M, Shah J, Duckworth W, Abraira C. The association between metabolic control and prevalent macrovascular disease in Type 2 diabetes: the VA Cooperative Study in diabetes. J Diabetes Complications,2006, 20:75–80
10. 10. Martin S, Schneider B, Heinemann L et al. Selfmonitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study. Diabetologia,2006, 49:271–278
11. 11. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care,2003, 26:S33–S50
12. 12. IDF Global Guideline for Type 2 Diabetes, 2011.
13. 13. Satman İ et al. TURDEP II results. Turkish Endocrinology and Metabolism Congress 2010
14. 14. İlkova İ et al. IDMPS Turkey 3rd wave results – The profile of Type 2 DM patients and the treatment methods. National Diabetes Congress 2010
15. 15. Barnett AH. A review of basal insulins. Diabet. Med,2003, 20, 873–885
16. 16. Lepore M. et al. Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of Long-Acting Human Insulin Analog Glargine, NPH Insulin, and Ultralente Human Insulin and Continuous Subcutaneous Infusion of Insulin Lispro Diabetes,2000, 49:2142–2148
17. 17. Ratner RE. et al. Less Hypoglycemia With Insulin Glargine in Intensive Insulin Therapy for Type 1 Diabetes Diabetes Care,2000, 23:639–643
18. 18. Ashwell S.G. et al. Improved Glycaemic Control with Insulin Glargine plus Insulin Lispro: A multicentre, Randomized, Cross-over Trial in People with Type 1 Diabetes. Diabetic Medicine,2006, 23, 285-292
19. 19. Home P.D. et al. A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes Diabetes Metab Res Rev 2005; 21: 545–553.
20. 20. Raskin P. et al. A 16-Week Comparison of the Novel Insulin Analog Insulin Glargine (HOE 901) and NPH Human Insulin Used With Insulin Lispro in Patients With Type 1 Diabetes Diabetes Care,2000, 23:1666–1671
21. 21. Benedetti M. et al. A One Year, Randomised, Multicentre Trial Comparing Insulin Glargine with NPH Insulin in Combination with Oral Agents in Patients with Type 2 Diabetes. Horm. Metab Res 2003;35: 189-196
22. 22. Herwig J. et al. Glycaemic Control and Hypoglycaemia in Children, Adolescents and Young Adults with Unstable Type 1 Diabetes Mellitus Treated with Insulin Glargine or Intermediate-acting Insulin Journal of Pediatrie Endocrinology & Metabolisrn,2007, 20: 517-525
23. 23. Mullins P. et al. Negative Binominal Meta-Regression Analysis of Combned Glycosylated Hemoglobin and Hypoglycaemia Outcomes Across Eleven Phase III and IV Studies of Insulin Glargine Compared with NPH Insulin in Type 1 and Type 2 DM. Clinical Therapeutics Volume 29, Number 8, 2007; 1607-1619
24. 24. White NH. et al. Comparison of Glycaemic Variability Associated With Insulin Glargine and Intermediate-Acting Insulin when used as the Basal Componennt of Multiple Daily Injections for Adolescents With Type 1 Diabetes. Diabetes Care,2009, 32:387-393
25. 25. Fritsche A et al. Glimepiride Combined with Morning Insulin Glargine, Bedtime Neutral Protamine Hagedorn Insulin, or Bedtime Insulin Glargine in Patients with Type 2 Diabetes. Ann Intern Med. 2003;138:952-959.
26. 26. Tsai ST et al. First Insulinization with Basal Insulin in Patients with Type 2 Diabetes in a Real-world Setting in Asia. Journal of Diabetes 3 ,2011, 208-216
27. 27. Chase HP. et al. Insulin Glargine Versus IntermediateActing Insulin as the Basal Component of Multiple Daily Injection Regimens for Adolescents with Type 1 Diabetes Mellitus. 10.1016/j.jpeds.2008.04.063
28. 28. Pan CY. et al. Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients Diabetes Research and Clinical Practice 76 ,2007, 111–118
29. 29. Riddle MC. et al. The Treat-to-Target Trial Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care,2003, 26:3080–3086
30. 30. Home P.D. et al. Meta-analysis of individual patient data to assess the risk of hypoglycaemia in people with type 2 diabetes using NPH insulin or insulin glargine. Diabetes, Obesity and Metabolism ,2010, 12:772-9.
31. 31. Linn T. et al. Nocturnal Glucose Metabolism after Bedtime Injection of Insulin Glargine or Neutral Protamine Hagedorn Insulin in Patients with Type 2 Diabetes. J Clin Endocrinol Metab,2008, 93: 3839–3846
32. 32. Bolli G.B. et al. Lower fasting blood glucose, glucose variability and nocturnal hypoglycaemia with glargine vs NPH basal insulin in subjects with Type 1 diabetes. Nutrition, Metabolism & Cardiovascular Diseases ,2009, 19: 571-579
33. 33. Eliaschewitz F.G. et al. Therapy in Type 2 Diabetes: Insulin Glargine vs. NPH Insulin Both in Combination with Glimepiride. Archives of Medical Research,2006, 37: 495–501
34. 34. Witthaus E. et al. Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with Type 1 diabetes. Diabetic Medicine,2001, 18: 619-625
35. 35. Bradley C, Gilbride CJ. Improving treatment satisfaction and other patient-reported outcomes in people with type 2 diabetes: the role of once-daily insulin glargine. Diabetes Obes Metab. 2008, Jul;10 Suppl 2:50-65
36. 36. Schreiber S.A., Russmann A. Long-term efficacy of insülin glargine therapy with an educational programme in type 1 diabetes patients in clinical practice. Current Medical Research and Opinion, 2007, Vol. 23, No. 123131–3136
37. 37. Gordon J et al. A comparison of intermediate and longacting insulins in people with type 2 diabetes starting insulin: an observational database study. Int J Clin Pract, 2010, 64, 12, 1609–1618
38. 38. Rhoads G. et al. Comparison of Incidence of Acute Myocardial Infarction in Patients With Type 2 Diabetes Mellitus Following Initiation of Neutral Protamine Hagedorn Insulin Versus Insulin Glargine. Am J Cardiol, 2009;104:910 –916
39. 39. Kurtzhals P. Engineering predictability and protraction in a basal insulin analog: the pharmacology of insulin detemir. Int J Obesity, 2004; 28 Suppl. 2: S23-8
40. 40. Hirsch IB. Insulin analogues. New Engl J Med, 2005; 352: 174-83
41. 41. 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. Diabetes Care ,2005; 28: 1107-12
42. 42. Heise T, Nosek I, Rønn BB, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. diabetes. Diabetes ,2004; 53: 1614-20
43. 43. Hermansen K. et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with Type 1 diabetes. Diabetologia, 2004; 47:622–629
44. 44. Dornhorst A, Lüddeke HJ, Sreenan S, et al. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract 2007; 61: 523 -8
45. 45. Rašlová K, Bogoev M, Raz I, et al. Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 2004 ; 66 (2): 193 -201. Corrigendum: Diabetes Res Clin Pract 2006 ; 72 : 112
46. 46. 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 : 56 -64
47. 47. Fajardo Montañana C, Hernández Herrero C, Rivas Fernández M. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensifi cation of insulin therapy in overweight type 2 diabetes patients – the PREDICTIVE™ BMI clinical trial. Diabet Med 2008
48. 48. Hermansen K, Davies M, Derezinski T, et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006; 29 : 1269 -74
49. 49. Philis-Tsimikas A, Charpentier G, Clauson P, et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006 ; 28 : 1569 -81
50. 50. Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007 ; 357 : 1716 -30
51. 51. Rosenstock J, Davies M, Home P, et al. A randomised, 52- week, treat-to-target trial comparing insulin detemir with insulin glargine when added to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008;51: 408 -26
52. 52. Meneghini L, Koenen C, Weng W, Selam J-L. The usage of a simplifi ed self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE™ 303 study. Diabetes Obes Metab 2007 ; 9 : 902 -13
53. 53. Athena Philis-Tsimikas. An update on the use of insulin detemir, with a focus on type 2 diabetes (drug evaluation update); Expert Opin. Pharmacother. 2008, 9(12):2181-2195
54. 54. P. Valensi, E. Cosson, Is insulin detemir able to favor a lower variability in the action of injected insulin in diabetic subjects? Diabetes Metab. 2005 31: 4S34–4S39.
55. 55. G.E. Peterson, Intermediate and long-acting insulins: a review of NPH insulin, insulin glargine and insulin detemir, Curr. Med. Res. Opin. 2006,22: 2613–2619.
56. 56. K. Horvath, K. Jeitler, A. Berghold, S.H. Ebrahim, T.W. Gratzer, J. Plank, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus, Cochrane Database Syst. Rev.2007, 2
57. 57. Heler S.et al Diversity in diabetes: the role of insulin aspart Diabetes Metab Res Rev. 2012 Jan;28(1):50-61
58. 58. Tamas G.Y et al. Glycaemic control in type 1 diabetic patients using optimised insulin aspart or human insulin in a randomised multinational study. Diabetes Research and Clinical Practice 2001,54: 105–114.
59. 59. NovoRapid Flexpen Kısa Ürün Bilgisi
60. 60. Home PD, Lindholm A, Riis A; European Insulin Aspart Study Group. Insulin aspart vs.human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet Med 2000; 17: 762–770.
61. 61. Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L. Use of insulin aspart, a fast-actinginsulin analog, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000; 23: 583–588.
62. 62. Bretzel RG, Arnolds S, Medding J, Linn T. A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care 2004; 27: 1023–1027
63. 63. Mathiesen ER, Kinsley B, Amiel SA, Heller S, McCance D, Duran S, Bellaire S, Raben A. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabetes Care 2007;30(4):771-6
64. 64. Heller SR, Colagiuri S, Vaaler S, et al. Hypoglycaemia with insulin aspart: a doubleblind,randomised, crossover trial in subjects with Type 1 diabetes. Diabet Med 2004; 21:769–775.
65. 65. Wilde MI, McTavish D. Insulin lispro: a review of its pharmacological properties and therapeutic use in the management of diabetes mellitus. Drug 1997; 54:597- 614
66. 66. Becker R. Frick AD, Burger F, Potgieter JH, Scholtz H. Insulin glulisine, a new rapid-acting insulin analogue, displays a rapid time-action profile in obese non-diabetic subjects. Exp Clin Endocrinol Diabetes 2005; 113:435- 443
67. 67. Becker R. Insulin glulisine complementing basal insulins: a review of structure and activity. Diabetes Technology Ther 2007;9: 109-121
68. 68. Becker R. Frick AD, Nosek L, Heinemann L, Rave K. Doseresponse relationship of insulin glulisine in subjects with type 1 diabetes. Diabetes Care 2007;30:2506-2507
69. 69. Garg SK, Rosenstock J, Ways K. Optimized Basal-bolus insulin regimens in type 1 diabetes: insulin glulisine versus regular human insulin in combination with Basal insulin glargine. Endocr Pract 2005;11: 11-17
70. 70. Dailey G, Rosenstock J, Moses RG, Ways K. Insulin glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care 2004; 27 : 2363-2368
71. 71. Danne T. Becker RH, Heise T, Bittner C, Frick AD, Rave K. Pharmacokinetics, prandial glucose control, and safety of insulin glulisine in children and adolescents with type 1 diabetes.Diabetes Care 2005; 28: 2100-2105
72. 72. Raymen G, Profozic V, Middle M. Insulin glulisine imparts effective glycaemic control in patients with Type 2 diabetes. Diabetes Res Clin Pract. 2007 ; 76:304-312.
73. 73. Overmann H, Heinemann L. Injection-meal interval: recommendations of diabetologists and how patients handle it. Diab Res Clin Pract 1999;43:137
74. 74. Raskin P et al. Initiation of insulin therapy in patients with type 2 diabetes failing oral therapy. Diab Care 2005; 28:2811
75. 75. Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care ,1997, Vol.20, No.10 , 1612-1614
76. 76. Jacobsen L.V,Sogaard B., Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol 2000, 56;399-403
77. 77. Home P.D, Barriconal L,Lindholm A. Comparative pharmacokinetics and pharmacodynamics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers. Eur J Clin Pharmacol 1999, 55:199-203
78. 78. Heise T, Heinemann L, Hövelmann U, Brauns B, Nosek L, Haahr HL, Olsen KJ Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and Basal-bolus therapy.Diabetes Care 2009 32:1431-1443
79. 79. McNally P G, Dean J D, Morris A.D, Wilkinson P D,Compion G, Heller S R. Using 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, Vol 30, No 5, 1044-1048
80. 80. Boehm B O, Home P.D., Behrendt C.,Kampt N.M., Lindholmt A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. 2002, Diabetes UK, Diabetes Medicine;19,393-399
81. 81. Boehm B. O, Vaz J.A,Brondsted L, Home P.D, Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. European Journal of Internal Medicine ,2004,15: 496-502
82. 82. Shestakova M, Sharma S.K, Almustafa M, Min K.W, Ayad N, Azar S.T, Danciulescu R. et al. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Current Medical Research and Opinion 2007, Vol 23, No.12, 3209-3214
83. 83. McSorley P T,Bell P M, Jacobsen L V, Kristiensen A, Lindholm A Clinical Therapeutics. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. 2002 Vol 24,No.4, 530-539
84. 84. Kapitza C,Rave K, Ostrowski K et al Reduced postprandial glycaemic excursion with biphasic insulin Aspart 30 injected immediately before a meal. Diabet Med 2004;21:500-501
85. 85. Garber A, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, Jain R. 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, Obesity and Metabolism 2006;8(1):58-66
86. 86. Ligthelm R J.Primary Care Diabetes. Self-titration of biphasic insulin aspart 30/70 improves glycaemic control and allows easy intensification in a Dutch clinical practice 2009 3,97-102
87. 87. Unnikrishnan A.G, Tibaldi J, Hadley- Brown M, Krentz A.J, Ligthelm R J, Damcı T. Practical guidance on intensification of insulin therapy with BIAsp 30: a consensus statement Int J Clin Pract. 2009 Nov;63(11):1571-7
88. 88. Wilde MI, McTavish D. Insulin lispro: a review of its pharmacological properties and therapeutic use in the management of diabetes mellitus. Drug 1997; 54:597- 614
89. 89. Koivisto VA, Tuominen JA, Ebeling P. Lispro Mix25 Insulin As Premeal Therapy in Type 2 Diabetic Patients Diabetes Care 1999;22:459–462)