Insulin aspart: A review

Expert Opinion on Drug Metabolism and Toxicology

Volumn 2, Issue 5, 2006, Pages 793-804

  Owens, David ^a   Vora, Jiten ^b  

^a LLANDOUGH HOSPITAL   (United Kingdom)

^b ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

Author keywords

Diabetes; Insulin analogues; Insulin aspart; Pharmacodynamics; Pharmacokinetics; Therapeutic use

Indexed keywords

HUMAN INSULIN; INSULIN ASPART;

DIABETES MELLITUS; DRUG ABSORPTION; DRUG BLOOD LEVEL; HUMAN; POSTPRANDIAL STATE; PREGNANCY; REVIEW;

BLOOD GLUCOSE; CLINICAL TRIALS; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN;

EID: 33846333174     PISSN: 17425255     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425255.2.5.793     Document Type: Review

References (88)

1. EXPERT COMMITTEE ON THE DIAGNOSIS AND CLASSIFICATION OF DIABETES MELLITUS: Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care (2003) 26(Suppl. 1):S5-S20.
2. THE DIABETES CONTROL AND COMPLICATIONS TRIAL RESEARCH GROUP: The effect of intensive treatment of diabetes on the development and the progression of long-term complications in insulin-dependent diabetes mellitus. N. Engl. J. Med. (1993) 329(14):977-986.
3. UNITED KINGDOM PROSPECTIVE DIABETES STUDY GROUP 2: A 6-year randomized, controlled, trial comparing sulphonylurea, insulin and metformin therapy in patients with newly diagnosed Type 2 diabetes that could not be controlled with diet therapy. Ann. Intern. Med. (1998) 128(3):165-175.
4. STRATTON I, ADLER A, NEIL H et al.: Association of glycaemia with macrovascular and microvasclar complications of Type 2 diabetes (UKPDS 35): prospective, observational study. BMJ (2000) 321(7258):405-412.
5. HOME P: Contributions of basal and post-prandial hyperglycaemia to micro- and macro-vascular complications n people with Type 2 diabetes. Curr. Med. Res. Opin. (2005) 21(7):989-998.
6. FEINGLOS MN, BETHEL MA: Emerging care for Type 2 diabetes: using insulin to reach lower glycemic goals. Cleve. Clin. J. Med. (2005) 72(9):791-799.
7. International Diabetes Federation (IDF) Global Guideline for Type 2 Diabetes. International Diabetes Federation, Brussels, Belgium (2005).
8. AMERICAN DIABETES ASSOCIATION: Standards of Medical Care in Diabetes. Diabetes Care (2005) 28(Suppl. 1):S4-S36.
9. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS: The American Association of Clinical Endocrinologists Medical Guidelines for the Management of Diabetes Mellitus: the AACE system of intensive diabetes self-management - 2002 update. Endocr. Pract. (2002) 8(Suppl. 1):40-82.
10. DAVIS SN, GRANNER DK: Insulin, oral hypoglycaemic agents, and the pharmacology of the endocrine pancreas. In: Goodman and Gilman's The Pharmacological Basis of Therapeutics, 10th edn. Hardman HG, Limbird LE (Eds), McGraw-Hill, New York, US (2001):1679-1714.
11. BLUNDELL T, DODSON G, HODGKIN D, MERCOLA D: Insulin: the structure in the crystal and its reflection in chemistry and biology. Adv. Protein Chem. (1972) 26:279-402.
12. BARNETT AH, OWENS DR: Insulin analogues. Lancet (1997) 349(9044):47-51.
13. OVERMANN H, HEINEMANN L: Injection-meal interval: recommendations of diabetologists and how patients handle it. Diabetes Res. Clin. Pract. (1999) 43(2):137-142.
14. BRANGE J, OWENS DR, KANG S, VØLUND A: Monomeric insulins and their experimental and clinical implications. Diabetes Care (1990) 13(9):923-954.
15. BRANGE J, RIBEL U, HANSEN JF et al.: Monomeric insulins obtained by protein engineering and their medical implications. Nature (1988) 333(6174):679-682.
16. HOME PD, BARRIOCANAL 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(3):199-203.
17. KANG S, CREAGH FM, PETERS JR, BRANGE J, VOLUND A, OWENS DR: Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in Type I diabetic subjects. Diabetes Care (1991) 14(7):571-577.
18. JOVANOVIC L, GIAMMATTEI J, ACQUISTAPACE M, BORNSTEIN K, SOMMERMANN E, PETTITT DJ: Efficacy comparison between preprandial and postprandial insulin aspart administration with dose adjustment for unpredictable meal size. Clin. Ther. (2004) 26(9):1492-1497.
19. BRUNNER GA, HIRSCHBERGER S, SENDLHOFER G et al.: Post-prandial administration of the insulin analogue insulin aspart in patients with Type 1 diabetes mellitus. Diabet. Med. (2000) 17(5):371-375.
20. DANNE T, AMAN J, SCHOBER E et al.; ANA 1200 STUDY GROUP: A comparison of postprandial and preprandial administration of insulin aspart in children and adolescents with Type 1 diabetes. Diabetes Care (2003) 26(8):2359-2364.
21. LINDHOLM A, JACOBSEN LV: Clinical pharmacokinetics and pharmacodynamics of insulin aspart. Clin. Pharmacokinet. (2001) 40(9):641-659.
22. RASKIN P, BODE BW, MARKS et al.: Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in Type 2 diabetes: a randomized, parallel-group, 24-week study. Diabetes Care (2003) 26(9):2598-2603.
23. BODE BW, STRANGE P: Efficacy, safety and pump compatibility of insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with Type 1 diabetes. Diabetes Care (2001) 24(1):69-72.
24. DREJER K: The bioactivity of insulin analogs from in vitro receptor binding to in vivo glucose uptake. Diabetes Metab. Res. (1992) 8(3):259-286.
25. HEINEMANN L, KAPITZA C, STARKE AA et al.: Time-action profile of the insulin analogue B28Asp. Diabet. Med. (1996) 13(7):683-684.
26. HEINEMANN L, WEYER C, RAUHAUS M et al.: Variability of the metabolic effect of soluble insulin and the rapid-acting insulin analog insulin aspart. Diabetes Care (1998) 21(11):1910-1914.
27. MUDALIAR SR, LINDBERG FA, JOYCE M et al.: Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care (1999) 22(9):1501-1506.
28. GALLOWAY JA, CHANCE RE: Improving insulin therapy: achievements and challenges. Horm. Metab. Res. (1994) 26(12):591-598.
29. GALLOWAY J, SPRADLIN C, NELSON R et al.: Factors influencing the absorption, serum insulin concentration and blood glucose responses after injection of regular insulin and various insulin mixtures. Diabetes Care (1981) 4(3):366-376.
30. NOSEK L, HEINEMANN L, KAISER M et al.: No increase in the duration of action with rising doses of insulin aspart. Diabetes (2003) 52(Suppl. 1):A128.
31. HOWEY DC, BOWSHER RR, BRUNELLE RL, WOODWORTH JR: [Lys(B28), Pro(B29)]-human insulin. A rapidly absorbed analogue of human insulin. Diabetes (1994) 43(3):396-402.
32. PLANK J, WUTTE A, BRUNNER G et al.: A direct comparison of insulin aspart and insulin lispro in patients with Type 1 diabetes. Diabetes Care (2002) 25(11):2053-2057.
33. ROSENFALCK AM, THORSBY P, KJEMS L et al.: Improved postprandial glycaemic control with insulin aspart in Type 2 diabetic patients treated with insulin. Acta Diabetol. (2000) 37(1):41-46.
34. VON MACH MA, BRINKMANN C, HANSEN T, WEILEMANN LS, BEYER J: Differences in pharmacokinetics and pharmacodynamics of insulin lispro and aspart in healthy volunteers. Exp. Clin. Endocrinol. Diab. (2002) 110(8):416-419.
35. LINDSTROM T, HEDMAN CA, ARNQVIST HJ: Use of a novel double-antibody technique to describe the pharmacokinetics of rapid-acting insulin analogs. Diabetes Care (2002) 25(6):1049-1054.
36. PLUM A, LARSEN PS, LARSEN UD et al.: Determination of the in vitro plasma protein binding of insulin aspart and insulin detemir by equilibrium dialysis. Diabetologia (1999) 42(Suppl. 1):A236.
37. LINDHOLM A, MCEWEN J, RIIS AP: Improved postprandial glycemic control with insulin aspart. A randomized double-blind cross-over trial in Type 1 diabetes. Diabetes Care (1999) 22(5):801-805.
38. THOMAS JH, JENKINS CDG, DAVEY PG et al.: The binding and degradation of 125I labeled insulin by rat-kidney brush border membranes. Int. J. Biochem. (1983) 15:329-336.
39. HALBERG IB, JACOBSEN LV, DAHL UL: A study on self-mixing insulin aspart with NPH insulin in the syringe before injection. Diabetes (1999) 48(Suppl. 1):A104.
40. BOEHM BO, HOME PD, BEHREND C, KAMP NM, LINDHOLM A: Premixed insulin aspart 30 versus 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.
41. MORTENSEN HB, LINDHOLM A, OLSEN BS, HYLLEBERG B: Rapid appearance and onset of action of insulin aspart in paediatric subjects with Type 1 diabetes. Eur. J. Pediatr. (2000) 159(7):483-488.
42. JACOBSEN LV, SOGAARD 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.
43. LINDHOLM A, SASAKI T, EDWARDS A et al.: Dose dependency in absorption of insulin aspart in healthy Caucasians and Japanese. Diabetes (2001) 50(Suppl. 2):A441.
44. HENRIKSEN JH, TRONIER B, BULOW JB: Kinetics of circulating endogenous insulin, C-peptide, and proinsulin in fasting nondiabetic man. Metabolism (1987) 36(5):463-468.
45. HOLMES G, GALITZ L, HU P, LYNESS W: Pharmacokinetics of insulin aspart in obesity, renal impairment or hepatic impairment. Br. J. Clin. Pharmacol. (2005) 60(5):469-476.
46. DEFRONZO RA, TOBIN JD, ROWE JW, ANDRES R: Glucose intolerance in uremia. Quantification of pancreatic β cell sensitivity to glucose and tissue sensitivity to insulin. J. Clin. Invest. (1978) 62(2):425-435.
47. ROSS S, GADSBY R: Diabetes and Related Disorders. Mosby, London, UK (2004).
48. HODD M, VISSER G, DAMM P et al.: Safety and perinatal outcome in pregnancy: a randomized trial comparing insulin aspart with human insulin and 322 subjects with Type 1 diabetes. Diabetes (2006) 55(Suppl. 1):A417.
49. MATHIESEN E, KINSLEY B, MCCANCE D et al.: Maternal hypoglycemia and glycemic control in pregnancy, a randomized trial comparing insulin aspart with human insulin in 322 subjects with Type 1 diabetes. Diabetes (2006) 55(Suppl. 1):A40.
50. PETTITT DJ, OSPINA P, KOLACZYNSKI JW, JOVANOVIC L: Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care (2003) 26(1):183-186.
51. JOVANOVIC J, HOWARD C, PETTITT D et al.: Safety and efficacy of insulin aspart versus regular human insulin in basal/bolus therapy for patients with gestational diabetes. Diabetes (2005) 54(Suppl. 1):A675.
52. DEVECIANA M, MAJOR CA, MORGAN MA: Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes requiring insulin therapy. M Engl. J. Med. (1995) 333(19):1237-1241.
53. JOVANOVIC L, ILIC S, PETTITT DJ et al.: Metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care (1999) 22(9):1422-1427.
54. CALLE-PASCUAL AL, BAGAZGOITIA J, CALLE JR, CHARRO A, MARANES JP: Use of insulin lispro in pregnancy. Diabetes Nutr. Metab. (2000) 13(3):173-177.
55. HOME PD, LINDHOLM A, HYLLEBERG B, ROUND P: Improved glycaemic control with insulin aspart: a multicentre randomized double-blind crossover trial in Type 1 diabetes patients UK Insulin Aspart Study Group. Diabetes Care (1998) 21(11):1904-1909.
56. CRYER PE: Hypoglycemia is the limiting factor in the management of diabetes. Diabetes Metab. Res. Rev. (1999) 15(1):42-46.
57. HOME PD, LINDHOLM A, RIIS A; for the EUROPEAN INSULIN ASPART STUDY GROUP: Insulin aspart versus human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet. Med. (2000) 17(11):762-770.
58. RASKIN P, GUTHRIE RA, LEITER L, RIIS A, JOVANOVIC L: Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with Type 1 diabetes. Diabetes Care (2000) 23(5):583-588.
59. 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(5):1023-1027.
60. BODE B, WEINSTEIN R, BELL D et al.: Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in Type 1 diabetes. Diabetes Care (2002) 25(3):439-444.
61. SIEBENHOFER A, PLANK J, BERGHOLD A et al.: Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. Cochrane Syst. Rev. (2006) 2:CD003287.
62. HELLER SR, COLAGIURI S, VAALER S et al.: Hypoglycaemia with insulin aspart: a double-blind, randomized, crossover trial in subjects with Type 1 diabetes. Diabet. Med. (2004) 21(7):769-775.
63. HERMANSEN K, FONTAINE P, KUKOLJA KK et al.: Insulin analogues (insulin aspart and insulin detemir) versus traditional insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with Type 1 diabetes. Diabetologia (2004) 47(4):622-629.
64. VAN HAEFTEN TW, HEILING VJ, GERICH JE: Adverse effects of insulin antibodies on postprandial plasma glucose and insulin profiles in diabetic patients without immune insulin resistance. Implications for intensive insulin regimens. Diabetes (1987) 36(3):305-309.
65. CHEN J-W, FRYSTYK J, LAURITZEN T, CHRISTIANSEN JS: Impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week treatment with multiple daily injections of biphasic insulin aspart 30 in patients with Type 1 diabetes. Eur. J. Endocrinol. (2005) 153(6):907-913.
66. RASKIN P, MCGILL J, KILO C, BOSS AH: Human insulin analog (insulin aspart, IAsp) is comparable to human insulin in Type 2 diabetes. Diabetes (1999) 48(Suppl. 1):A355.
67. LINDHOLM A, JENSEN LB, HOME PD, RASKIN P, BOEHM BO, RASTAM J: Immune responses to insulin aspart and biphasic insulin aspart in people with Type 1 and Type 2 diabetes. Diabetes Care (2002) 25(5):876-882.
68. ZWICKL CM, SMITH HW, ZIMMERMANN JL, WIERDA D: Immunogenicity of biosynthetic human LysPro insulin compared to native-sequence human and purified porcine insulins in rhesus monkeys immunized over a 6-week period. Arzneimittelforschung (1995) 45(4):524-528.
69. EAPEN SS, CONNOR EL, GERN JE: Insulin desensitization with insulin lispro and an insulin pump in a 5-year-old child. Ann. Allergy Asthma Immunol. (2000) 85(5):395-397.
70. AIRAGHI L, LORINI M, TEDESCHI A: The insulin analog aspart: a safe alternative to insulin allergy. Diabetes Care (2001) 24(11):2000.
71. LAHTELA JT, KNIP M, PAUL R, ANTONEN J, SALMI J: Severe antibody-mediated human insulin resistance: successful treatment with the insulin analog lispro. A case report. Diabetes Care (1997) 20(1):71-73.
72. KURTZHALS P, SCHAFFER L, SORENSEN A et al.: Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes (2000) 49(6):999-1005.
73. HANSEN BF, DANIELSEN GM, DREJER K et al.: Sustained signalling from the insulin receptor after stimulation with insulin analogues exhibiting increased mitogenic potency. Biochem. J. (1996) 315(1):271-279.
74. PERIELLO G, PAMPANELLI S, PORCELLATI F et al.: Insulin aspart improves meal time glycaemic control in patients with Type 2 diabetes: a randomized, stratified, double-blind and crossover trial. Diabet. Med. (2005) 22(5):606-611.
75. GALLAGHER A, HOME PD: The effect of improved post-prandial blood glucose control on post-prandial metabolism and markers of vascular risk in people with Type 2 diabetes. Diabetes Res. Clin. Pract. (2005) 67(3):196-203.
76. POULSEN MK, HENRIKSEN JE, HOTHER-NIELSEN O, BECK-NIELSEN H: The combined effect of triple therapy with rosiglitazone, metformin, and insulin aspart in Type 2 diabetic patients. Diabetes Care (2003) 26(12):3273-3279.
77. DE BOER H, JANSEN M, KOERTS J et al.: Prevention of weight gain in Type 2 diabetes requiring insulin treatment. Diabetes Obes. Metab. (2004) 6(2):114-119.
78. HOME PD, HALLGREN P, USADEL KH et al.: Pre-meal insulin aspart compared with pre-meal soluble human insulin in Type 1 diabetes. Diabetes Res. Clin. Pract. (2006) 71(2):131-139.
79. HOME P, BARTLEY P, RUSSELL-JONES D et al.: Insulin detemir offers improved glycemic control compared with NPH insulin in people with Type 1 diabetes: a randomized clinical trial. Diabetes Care (2004) 27(5):1081-1087.
80. SIEBENHOFER A, PLANK J, BERGHOLD A et al.: Meta-analysis of short-acting insulin analogues in adult patients with Type 1 diabetes; continuous subcutaneous insulin infusion versus injection. Diabetologia (2004) 47(11):1895-2095.
81. DE VRIES JH, SNOEK FJ, KOSTENE PJ et al.: A randomised trial of continuous subcutaneous insulin infusion and intensive injection therapy in Type 1 diabetes patients with long standing poor glycaemic control. Diabetes Care (2002) 25(11):2074-2080.
82. ABRAHAMIAN H, LUDVIK B, SCHERNTHANER G et al.: Improvement of glucose tolerance in Type 2 diabetic patients: traditional versus modern insulin regimens (results from the Austrian Biaspart Study). Horm. Metab. Res. (2005) 37(11):684-689.
83. ROSENN BM, MIODOVNIK M, HOLCBERG G, KHOURY JC, SIDDIQ TA: Hypoglycemia: the price of intensive insulin therapy for pregnant women with insulin-dependent diabetes mellitus. Obstet. Gynecol. (1995) 85(3):417-422.
84. TAMAS G, MARRE M, ASTORGA R et al.: Insulin aspart study. Glycaemic control in Type 1 diabetic patients using optimised insulin aspart or human insulin in a randomised multinational study. Diabetes Res. Clin. Pract. (2001) 54(2):105-114.
85. FUNNELL MM, KRUGER DF: Type 2 diabetes: treat to target. Nurse Pract. (2004) 29(1):11-15.
86. HALL JA, SUMMERS KH, OBENCHAIN RL: Cost and utilization comparisons among propensity score-matched insulin lispro and regular insulin users. J. Manag. Care Pharm. (2003) 9(3):263-268.
87. JORGENSEN LN, DIDERIKSEN LH, DREYER K: Carcinogenic effect of the human insulin analog B-10 in female rates. Diabetologia (1992) 35(Suppl. 1):A3.
88. http://www.eatlas.idf.org IDF Diabetes Atlas, 2nd edn (2005). Accessed 27 March 2006.