Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus

Cochrane Database of Systematic Reviews

Volumn , Issue 2, 2006, Pages

  Siebenhofer, Andrea ^a   Plank, J ^b   Berghold, A ^b   Jeitler, K ^b   Horvath, K ^b   Narath, M ^b   Gfrerer, R ^b   Pieber, T R ^b  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

^b NONE

Author keywords

Diabetes mellitus, type 1 blood; *drug therapy ; Diabetes mellitus, type 2 blood; *drug therapy ; Hemoglobin A, glycosylated metabolism ; Hypoglycemic agents *therapeutic use

Indexed keywords

HEMOGLOBIN A1C; HUMAN INSULIN; INSULIN ASPART; INSULIN GLULISINE; INSULIN LISPRO;

CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTINUOUS INFUSION; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; INSULIN DEPENDENT DIABETES MELLITUS; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; PREGNANCY DIABETES MELLITUS; REVIEW;

EID: 42749106543     PISSN: 1469493X     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD003287.pub4     Document Type: Review

References (127)

1. Altuntas Y, Ozen B, Ozturk B, Sengul A, Ucak S, Ersoy O, et al. Comparison of additional metformin or NPH insulin to mealtime insulin lispro therapy with mealtime human insulin therapy in secondary OAD failure. Diabetes, Obesity and Metabolism 2003;5(6):371-8.
2. Anderson JH, Brunelle RL, Keohane P, Koivisto VA, Trautmann ME, Vignati L, et al. Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Archives of Internal Medicine 1997;157(11):1249-55.
3. Anderson JH, Brunelle RL, Koivisto VA, Pfuetzner A, Trautmann ME, Vignati L, et al. Reduction of postprandial hyperglycemia and frequency of hypoglycemia in IDDM patients on insulin-analog treatment. Multicenter Insulin Lispro Study Group. Diabetes 1997;46(2):265-70.
4. Anderson JH, Brunelle RL, Koivisto VA, Trautmann ME, Vignati L, DiMarchi R. Improved mealtime treatment of diabetes mellitus using an insulin analogue. Multicenter Insulin Lispro Study Group. Clinical Therapeutics 1997;19(1):62-72.
5. Annuzzi G, Del Prato S, Arcari R, Bellomo Damato A, Benzi L, Bruttomesso D, et al. Preprandial combination of lispro and NPH insulin improves overall blood glucose control in type 1 diabetic patients: a multicenter randomized crossover trial. Nutrition, metabolism, and cardiovascular diseases 2001;11:168-75.
6. 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.
7. Bode B, Weinstein R, Bell D, McGill J, Nadeau D, Raskin P, et al. Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion. Diabetes Care 2002;25(3):439-44.
8. see Bode 2002.
9. Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Pre-mixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients. Diabetic Medicine 2002;19:393-9.
10. Bott U, Ebrahim S, Hirschberger S, Skovlund SE. Effect of the rapid-acting insulin analogue insulin aspart on quality of life and treatment satisfaction in patients with Type 1 diabetes. Diabetic Medicine 2003;20:626-34.
11. Bretzel RG, Arnolds S, Medding J, Linn T. A direct efficacy and safety of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care 2004;27:1023-7.
12. Chan WB, Chow DD, Yeung VTF, Chan JCN, So WY, Cochram CS. Effect of insulin lispro on glycaemic control in chinese diabetic patients receiving twice-daily regimens of insulin. Chinese Medical Journal 2004;117(9):1404-7.
13. Ciofetta M, Lalli C, Del Sindaco P, Torlone E, Pampanelli S, Mauro L, et al. Contribution of postprandial versus interprandial blood glucose to HbA1c in type 1 diabetes on physiologic intensive therapy with lispro insulin at mealtime. Diabetes Care 1999;22(5):795-800.
14. Deeb LC, Holcombe JH, Brunelle R, Zalani S, Brink S, Jenner M, et al. Insulin lispro lowers postprandial glucose in prepubertal children with diabetes. Pediatrics 2001;108(5):1175-9.
15. * Del Sindaco P, Ciofetta M, Lalli C, Perriello G, Pampanelli S, Torlone E, et al. Use of the short-acting insulin analogue lispro in intensive treatment of type 1 diabetes mellitus: Importance of appropriate replacement of basal insulin and time-interval injection-meal. Diabetic Medicine 1998;15(7):592-600.
16. Ferguson SC, Strachan MWJ, Janes JM, Frier BM. Severe hypoglycaemia in patients with type 1 diabetes and impaired awareness of hypoglycaemia: a comparative study of insulin lispro and regular human insulin. Diabetes/metabolism research and reviews 2001;17(4):285-91.
17. Ford-Adams ME, Murphy NP, Moore EJ, Edge JA, Ong KL, Watts AP, et al. Insulin lispro: a potential role in preventing nocturnal hypoglycaemia in young children with diabetes mellitus. Diabetic Medicine 2003;20:656-60.
18. Gale EAM. A randomized, controlled trial comparing insulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy. Diabetic Medicine 2000;17(3):209-14.
19. 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 research and clinical practice 2005;67:196-203.
20. Garg. Optimal basal bolus insulin in type 1 diabetes: insulin glulisine insulin versus regular human insulin in combination with basal insulin glargine. Endocrine Practice 2005;11:11-7.
21. Hedman CA, Orre-Pettersson AC, Lindstrom T, Arnqvist HJ. Treatment with insulin lispro changes the insulin profile but does not affect the plasma concentrations of IGF-I and IGFBP-1 in type 1 diabetes. Clinical Endocrinology 2001;55(1):107-12.
22. Heller SR, Amiel SA, Mansell P. Effect of the fast-acting insulin analog lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. Diabetes Care 1999;22(10):1607-11.
23. Heller SR, Colagiuri S, Vaaler S, Wolffenbuttel BHR, Koelendorf K, et al. Hypoglycaemia with insulin aspart: a double-blind, randomised, cross over trial in subjects with tpye 1 diabetes. Diabetic medicine : a journal of the British Diabetic Association 2004;21:769-75.
24. Herz M, Profozic V, Arora V, Smircic-Duvnjak L, Kovacevic I, Boras J, et al. Effects of a fixed mixture of 25% insulin lispro and 75% NPL on plasma glucose during and after moderate physical exercise in patients with type 2 diabetes. Current Medical Research and Opinion 2002;18(4):188-93.
25. Herz M, Arora V, Campaigne BN, Scholtz HE, Potgieter MA, Mollentze W. Humalog Mix25 improves 24-hour profiles compared with the human insulin mixture 30/70 in patients wioth type 2 diabetes mellitus. South African medical journal 2003;93:219-23.
26. Holcombe JH, Zalani S, Arora VK, Mast CJ. Comparison of insulin lispro with regular human insulin for the treatment of type 1 diabetes in adolescents. Clinical Therapeutics 2002;24(4):626-38.
27. Holleman F, Schmitt H, Rottiers R, Rees A, Symanowski S, Anderson JH. Reduced frequency of severe hypoglycemia and coma in well-controlled IDDM patients treated with insulin lispro. Diabetes Care 1997; Vol. 20, issue 12:1827-32.
28. Home PD, Lindholm A, Hylleberg B, Round P. Improved glycemic control with insulin aspart: a multicenter randomized double-blind crossover trial in type 1 diabetic patients. Diabetes Care 1998;21(11):1904-9.
29. Home PD, Lindholm A, Riis A. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabetic Medicine 2000;17(11):762-70.
30. Iwamoto Y, Akanuma Y, Niimi H, Sasaki N, Tajima N, Kawamori R, et al. Comparison between insulin aspart and soluble human insulin in type 1 diabetes (IDDM) patients treated with basal-bolus insulin therapy - Phase III clinical trial in Japan. Journal of the Japan Diabetes Society 2001;44(10):799-811.
31. Jacobs MAJM, Keulen ETP, Kanc K, Castelijn S, Scheffer P, Deville W, et al. Metabolic efficacy of preprandial administration of Lys (B28),Pro(B29) human insulin analog in IDDM patients. Diabetes Care 1997;20(8):1279- 86.
32. Johansson UB, Adamson UCK, Lins PES, Wredling RAM. Improved blood glucose variability, HBA1C Insuman Infusat and less insulin requirement in IDDM patients using insulin lispro in CSII. The Swedish multicenter lispro insulin study. Diabetes Metabolism 2000;26(3):192-6.
33. Jovanovic L, Ilic S, Pettitt DJ, Hugo K, Gutierrez M, Bowsher RR, et al. Metabolic and immunologic effects of insulin lispro in gestational diabetes. Diabetes Care 1999;22(9):1422-7.
34. Kotsanos JG, Vignati L, Huster L, Andrejasich C, Boggs MB, Jacobson AM, et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro. Diabetes Care 1997;20(6):948-58.
35. Mecacci F, Carignani L, Cioni R, Bartoli E, Parretti E, La Torre P, et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. European journal of obstetrics, gynecology, and reproductive biology 2003;111:19-24.
36. Persson B, Swahn ML, Hjertberg R, Hanson U, Nord E, Nordlander E, et al. Insulin lispro therapy in pregnancies complicated by type 1 diabetes mellitus. Diabetes Research and Clinical Practice 2002;58:115-21.
37. Provenzano C, Vero R, Oliva A, Leto G, Puccio L, Vecci E, et al. Lispro insulin in Type 1 diabetic patients on a mediterranean or normal diet: A randomized, cross-over comparative study with regular insulin. Diabetes, nutrition & metabolism 2001;14(3):133-9.
38. 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):583-8.
39. Raskin P, Holcombe JH, Tamborlane WV, Malone JI, Strowig S, Ahern JA, et al. A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump. The Journal of diabetic complications 2001;15(6):295-300.
40. Recasens M, Aguilera E, Morinigo R, Casamitjana R, Nicoletti F, Gomis R, et al. Insulin lispro is as effective as regular insulin in optimising metabolic control and preserving ß-cell function at onset of type 1 diabetes mellitus. Diabetes Research and Clinical Practice 2003;60:153-9.
41. Renner R, Pfuetzner A, Trautmann ME, Harzer O, Sauter K, Landgraf R. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Diabetes Care 1999;22(5):784-8.
42. Roach P, Trautmann ME, Arora V, Sun B, Anderson JH. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro Mix25 and insulin lispro Mix50. Clinical Therapeutics 1999;21(3):523-34.
43. Roach P, Yue L, Arora V. Improved postprandial glycemic control during treatment with Humalog Mix25, a novel protamine-based insulin lispro formulation. Diabetes Care 1999;22(8):1258-61.
44. Ross SA, Zinman B, Campos RV, Strack T. A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents. Clinical and investigative medicine 2001;24(6):292-8.
45. Schmauss S, Koenig A, Landgraf R. Human insulin analogue [LYS (B28), PRO(B29)]: the ideal pump insulin?. Diabetic Medicine 1998;15(3):247-9.
46. Skrha J, Smahelova A, Andel M, Vrtovec M, Subic J, Kreze A, et al. Insulin lispro improves postprandial glucose control in patients with diabetes mellitus [Inzulin lispro zlepsuje postprandialni glykemii u pacientu s diabetes mellitus]. Sbornik lekarsky 2002;103(1):15-21.
47. Tubiana-Rufi N, Coutant R, Bloch J, Munz-Licha G, Delcroix C, Montaud-Ragideau N, et al. Special management of insulin lispro in continuous subcutaneous insulininfusion in young diabetic children: a randomized cross-over study. Hormone research 2004;62:265-71.
48. Tupola S, Komulainen J, Jääskeläinen J, Sipilä I. Post-prandial insulin lispro vs. human regular insulin in prepubertal children with Type 1 diabetes mellitus. Diabetic Medicine 2001;18:654-8.
49. Vignati L, Anderson JH Jr, Iversen PW. Efficacy of insulin lispro in combination with NPH human insulin twice per day in patients with insulin-dependent or non-insulin-dependent diabetes. Clinical Therapeutics 1997;19(6):1408-21.
50. Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T. Insulin lispro in CSII: Results of a double-blind crossover study. Diabetes 1997;46(3):440-3.
51. Bastyr III EJ, Huang Y, Brunelle RL, Vignati L, Cox DJ, Kotsanos JG. Factors associated with nocturnal hypoglycaemia among patients with type 2 diabetes new to insulin therapy: Experience with insulin lispro. Diabetes Obesity and Metabolism 2000;2(1):39-46.
52. Boehm BO, Vaz JA, Bronsted L, Home PD. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. European journal of internal medicine 2004;15(8):496-502.
53. Colombel A, Murat A, Krempf M, Kuchly-Anton B, Charbonnel B. Improvement of blood glucose control in type 1 diabetic patients treated with lispro and multiple NPH injections. Diabetic Medicine 1999;16(4):319-24.
54. Cypryk K, Sobczak M, Petynska-Marczewska M, Zawodniak-Szalapska M, Szymczak W, Wilczynski J, et al. Pregnancy complications and perinatal outcome in diabetic women treated with Humalog (insulin lispro) or regular human insulin during pregnancy. Medical science monitor : international medical journal of experimental and clinical research 2004;10(2):29-32.
55. DeVries JH, Lindholm A, Jacobsen JL, Heine RJ, Home PD. A randomized trial of insulin aspart with intensified basal NPH insulin supplementation in people with Type 1 diabetes. Diabetic Medicine 2003;20:312-8.
56. Fineberg NS, Fineberg SE, Anderson JH, Birkett MA, Gibson RG, Hufferd S. Immunologic effects of insulin lispro [Lys (B28), Pro (B29) human insulin] in IDDM and NIDDM patients previously treated with insulin. Diabetes 1996;45(12):1750-4.
57. Garg SK, Carmain JA, Braddy KC, Anderson JH, Vignati L, Jennings MK, et al. Pre-meal insulin analogue insulin lispro vs humulin insulin treatment in young subjects with type 1 diabetes. Diabetic Medicine 1996;13(1):47-52.
58. Garg SK, Anderson JH, Gerard LA, Mackenzie TA, Gottlieb PA, Jennings MK, et al. Impact of insulin lispro on HbA1c values in insulin pump users. Diabetes Obesity and Metabolism 2000;2(5):307-11.
59. Heller SR, Amiel SA, Evans ML, Kong MF, Macdonald IA, Peacey SR. Does insulin lispro preserve the physiological defences to hypoglycaemia during intensive insulin therapy with a conventional basal bolus regimen?. Diabetes, Obesity and Metabolism 2002;4:106-12.
60. Herz M, Arora V, Sun B, Ferguson SC, Bolli GB, Frier BM. Basal-bolus insulin therapy in type 1 diabetes: comparative study of pre-meal administration of a fixed mixture of insulin lispro (50%) and neutral protamine lispro (50%) with human soluble insulin. Diabetic Medicine 2002;19:917-23.
61. Janssen MMJ, Snoek FJ, Masurel N, Hoogma RPLM, Deville WL, Popp-Snijders C, et al. Optimized basal-bolus therapy using a fixed mixture of 75% lispro and 25% NPL insulin in type 1 diabetes patients: No favorable effects on glycemic control, physiological responses to hypoglycemia, well-being, or treatment satisfaction. Diabetes Care 2000;23(5):629-33.
62. Jansson PA, Ebeling P, Smith U, Conget I, Coves MJ, Gomis R, et al. Improved glycemic control can be better maintained with insulin lispro than with human regular insulin. Diabetes, Nutrition and Metabolism Clinical and Experimental 1998;11(3):194-9.
63. Kaplan W, Rodriguez LM, Smith OE, Haymond MW, Heptulla RA. Effects of mixing glargine and short-acting insulin analogs on glucose control. Diabetes Care 2004;27(11):2739-40.
64. Kaufman FR. Use of insulin pump therapy at nighttime only for children 7-10 years of age with type 1 diabetes. Diabetes Care 2000;23(5):579-82.
65. Kilo C, Mezitis N, Jain R, Mersey J, McGill J, Raskin P. Starting patients with type 2 diabetes on insulin therapy using once-daily injections of biphasic insulin aspart 70/30, biphasic insulin 70/30, or NPH insulin combination with metformin. Journal of diabetes and its complications 2003;17:307-13.
66. Krzymien J, Rosinski G, Erhmann A, Karnafel W. Efficacy and safety of continuous subcutaneous insulin infusion using Lispro analog in treatment of patients with new diagnosed type 1 diabetes. Diabetologia Polska 2001;7 Suppl 1:16-22.
67. Lalli C, Ciofetta M, Del Sindaco P, Torlone E, Pampanelli S, Compagnucci P, et al. Long-term intensive treatment of type 1 diabetes with the short-acting insulin analog lispro in variable combination with NPH insulin at mealtime. Diabetes Care 1999;22(3):468-77.
68. Laube H, Heller M, Liersch J, Mäser E, Linn Th. Experience with Lispro-insulin in the intensified therapy of IDDM and NIDDM patients. Diabetes und Stoffwechsel 1996;5(6):273-6.
69. Loba J. Glycemic control in obese insulin-resistant type 2 diabetic patients treated with insulin lispro. Diabetologia Polska 2001;7 Suppl 1:29-34.
70. Martin D, Licha-Müntz G, Grasset E, Greneche MO, Nouet D, Francois L, et al. Efficacy of humalog injections before an afternoon meal and their acceptance by children and adolescents with type 1 diabetes. Diabetic Medicine 2002;19:1026-31.
71. Mc Sorley PT, Bell PM, Vestergard Jacobsen L, Kristensen A, Lindholm A. Twice-daily biphasic insulin aspart 30 versus biphasic hunam insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clinical Therapeutics 2002;24(4):530-9.
72. Melki V, Renard E, Lassmann-Vague V, Boivin S, Guerci B, Hanaire-Broutin H, et al. Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care 1998;21(6):977-82.
73. Nielsen FS, Jorgensen LN, Ipsen M, Voldsgaard AI, Parving HH. Long-term comparison of human insulin analogue B10Asp and soluble human insulin in IDDM patients on a basal/bolus insulin regimen. Diabetologia 1995;38(5):592-8.
74. Petersen KG, Schiwitz B, Khalaf AN. Intensive insulin therapy in type II diabetic patients. Comparison of regular insulin and a rapidly acting insulin analogue. Münchener Medizinische Wochenschrift 1995;137(27): 467-70.
75. Pfuetzner A, Kuestner E, Forst T, Schulze-Schleppinghoff B, Trautmann ME, Haslbeck M, et al. Intensive insulin therapy with insulin lispro in patients with type 1 diabetes reduces the frequency of hypoglycemic episodes. Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association 1996;104(1):25-30.
76. Roach P, Strack T, Arora V, Zhao Z. Improved glycemic control with the use of self-prepared mixtures of insulin lispro and insulin lispro protamine suspension in patioents with types 1 and 2 diabetes. International journal of clinical practice 2001;55(3):177-82.
77. Sargin H, Sargin M, Altuntas Y, Sengül AM, Orbay E, Seber S, et al. Comparison of lunch and bedtime NPH insulin plus mealtime insulin Lispro therapy with premeal regular insulin plus bedtime NPH insulin therapy in type 2 diabetes. Diabetes research and clinical practice 2003;62:79-86.
78. Schernthaner G, Kopp HP, Ristic S, Muzyka B, Peter L, Mitteregger G. Metabolic control in patients with type 2 diabetes using humalog mix 50 injected three times daily: crossover comparison with human insulin 30/70. Hormone and metabolic research 2004;36(3):188-93.
79. Tamas G, Marre M, Astorga R, Dedov I, Jacobsen J, Lindholm A. 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(2):105-14.
80. Tsui EYL, Chiasson JL, Tildesley H, Barnie A, Simkins S, Strack T, et al. Counterregulatory hormone responses after long-term continuous subcutaneous insulin infusion with lispro insulin. Diabetes Care 1998;21:93-6.
81. Velussi M. Lispro insulin treatment in comparison with regular human insulin in Type 2 diabetic patients living in nursing homes. Diabetes, nutrition & metabolism 2002;15(2):96-100.
82. American Diabetes Association. Report of the Expert Committee on the Diagnosis and Classification of diabetes mellitus. Diabetes Care 1997;20:1183-97.
83. Ahmed ABE, Home PD. The effect of the insulin analog lispro on night time blood glucose control in type 1 diabetic patients. Diabetes Care 1998;21:32-7.
84. Akalin S, Erbas T, Yilmaz MT, Ilkova H, Satman I, Ersanli Z, et al. Safety and efficacy of [Lys(B28), Pro(29)]-human insulin in patients with diabetes mellitus. Israel Journal of Medical Sciences 1997;33:716-9.
85. Berger M, Jörgens V. Insulintherapie in der Praxis. Berlin, Heidelberg: Springer Verlag, 2001:1-327.
86. Bolli GB, Di Marchi RD, Park GD, Pramming S, Koivisto VA. Insulin analogues and their potential in the management of diabetes mellitus. Diabetologia 1999;42:1151-67.
87. Bott U, Mühlhauser I, Overmann H, Berger M. Validation of a diabetes-specific quality of life scale for patients with type 1 diabetes. Diabetes Care 1998;21:757-69.
88. Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabetic Medicine 1990;7(5):445-51.
89. Bradley C. A guide to psychological measurement in diabetes research and practice. Handbook of Psychology and Diabetes. Routledge, 1994.
90. Brunelle RL, Llewelyn J, Anderson JH Jr, Gale EAM, Koivisto VA. Meta-analysis of the effect of insulin lispro on severe hypoglycemia in patients with type 1 diabetes. Diabetes Care 1998;21(10):1726-31.
91. Brunner GA, Hirschberger S, Sendlhofer G, Wutte A, Ellmerer M, Balent B, et al. Post-prandial administration of the insulin analogue insulin aspart in patients with Type 1 diabetes mellitus. Diabetic Medicine 2000;17(5):371-5.
92. Cohen J. A coefficient of agreement for nominal scales. Educational and Psychological Measurement 1960;20:37-46.
93. Colquitt J, Royle P, Waugh N. Are analogue insulins better than soluble in continuous subcutaneous insulin infusion? Results of a meta-analysis. Diabetic Medicine 2003;20:863-6.
94. Cox DJ, Irvine A, Gonder-Frederick L, Nowaek G, Butterfield J. Fear of hypoglycemia: quantification, validation and utilization. Diabetes Care 1987;10:617-21.
95. Cryer PE. Hypoglycaemia: The limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia 2002;45:937-48.
96. Curtin F, Altman DG, Elbourne DR. Meta-analysis combining parallel and cross-over clinical trials I:continuous outcomes. Statistics in medicine 2002;21:2131-44.
97. Davey P, Grainger D, MacMillan J, Rajan N, Aristides M, Gliksman M. Clinical outcomes with insulin lispro compared with human regular insulin: a meta-analysis. Clinical Therapeutics 1997;19(4):656-74.
98. The DCCT Research Group. Reliability and validity of a diabetes quality-of-life for the diabetes control and complications trial. Diabetes Care 1988;11:725-32.
99. The DCCT Research Group. Epidemiology of severe hypoglycemia in the diabetes control and complications Trial. The American journal of medicine 1991;90:450-9.
100. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The New England journal of medicine 1993;329:977-86.
101. Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington HV, Vail A. Meta-analysis involving cross-over trials: methological issues. International journal of epidemiology 2002;31:140-9.
102. Gerstein HC, Haynes RB. Evidence-based diabetes care. Hamilton: BC Decker Inc, 2001.
103. Grant MB, Mames RN, Fitzgerald C, Ellis EA, Aboufrikha M, Guy J. Insulin-like growth factor I acts as an angiogenic agent in rabbit cornea and retina: comparative studies with basic fibroblast growth factor. Diabetologia 1993;36:282-91.
104. Haffner SM. The importance of hyperglycemia in the nonfasting state to the development of cardiovascular disease. Endocrine Reviews 1998;19(5):583-92.
105. Heinemann L. Do insulin-treated diabetic patients use an injection-meal-interval in daily life?. Diabetic Medicine 1995;12(5):449-50.
106. Heinemann L, Kapitza C, Starke AAR, Heise T. Time-action profile of the insulin analogue B28Asp. Diabetic Medicine 1996;13:683-4.
107. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. In: The Cochrane Library, Issue 3, 2005. Chichester, UK: John Wiley & Sons, Ltd.
108. Homko C, Deluzio A, Jimenez C, Kolaczynski JW, Boden G. Comparison of insulin aspart and lispro. Diabetes Care 2003;26:2027-31.
109. Howey DC, Bowsher RR, Brunelle RL, Woodworth JR. [Lys(B28), Pro(B29)]-human insulin A rapidly absorbed analogue of human insulin. Diabetes 1994;43:396-402.
110. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17(1):1-12.
111. Jørgensen LN, Didriksen LH, Drejer K. Carciogen effect of the human insulin analogue B10 Asp in female rats. Diabetologia 1992;35 Suppl 1:A3.
112. Kadiri A, Al Nakhi A, El Ghazali S, Jabbar A, Al Arouj M, Akram J, et al. Treatment of type 1 diabetes with insulin lispro during Ramadan. Diabetes Metabolism 2001;27:482-6.
113. King GL, Goodman AD, Buzney S, Moses A, Kahn CR. Receptors and growth-promoting effects of insulin and insulin-like growth factors on cells from bovine retinal capillaries and aorta. Journal of Clinical Investigation 1985;75:1028-36.
114. Kurtzhals P, Schäffer L, Sorensen A, Kristensen C, Jonassen I, Schmid C, et al. Correlation of receptor binding and metabolic and metogenic potencies of insulin analogues designed for clinical use. Diabetes 2000;49:999-1005.
115. Marshall SM, Home PD, Rizza RA. The diabetes annual 12. Elsevier Science Ltd, 1999.
116. Martin JM, Anderson DM, UK Lispro Study Group. A short-acting insulin analogue in clinical practice. Diabetic Medicine 1994;11(3):35 (Abstract).
117. Mosekilde E, Skovbo JK, Binder C, Pramming S, Thorsteinsson B. Modeling absorption kinetics of subcutaneous injected soluble insulin. Journal of Pharmacokinetics and Biopharmaceutics 1989;17(1):67-87.
118. Muehlhauser I, Overmann H, Bender R, Bott U, Berger M. Risk factors of severe hypoglycaemia in adult patients with Type 1 diabetes - a prospective population based study. Diabetologia 1998;41:1274-82.
119. Plank J, Wutte A, Brunner G, Siebenhofer A, Semlitsch B, Sommer R, et al. A direct comparison of insulin aspart and insulin lispro in patients with type 1 diabetes. Diabetes Care 2002;25:2053-7.
120. Pramming S, Thorsteinsson B, Bendtson I, Binder C. The relationship between symptomatic and biochemical hypoglycemia in insulin-dependent diabetic patients. The Journal of international medical research 1990;228:641-6.
121. Ronnemaa T, Viikari J. Reducing snacks when switching from conventional soluble to lispro insulin treatment: Effects on glycaemic control and hypoglycaemia. Diabetic Medicine 1998;15(7):601-7.
122. Schernthaner G, Wein W, Sandholzer K, Equiluz-Bruck S, Bates PC, Birkett MA. Postprandial insulin lispro: a new therapeutic option for type 1 diabetic patients. Diabetes Care 1998;21(4):570-3.
123. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Journal of the American Medical Association 1995;273(5):408-12.
124. Shukla V K, Otten N. Insulin lispro: A critical evaluation. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 1999. Report No.: 18.
125. Torlone E, Fanelli C, Rambotti AM, Kassi G, Modarelli F, Di Vicenzo A, et al. Pharmacokinetics, pharmacodynamics and glucose counter-regulation following subcutaneous injection of the monomeric insulin analogue [Lys(B28),Pro(B29)] in IDDM. Diabetologia 1994;37(7):713-20.
126. World Health Organisation. Diabetes mellitus. Report of a WHO Study Group. WHO Technical Report Series; 1985. Report No.: 727.
127. Zinman B. The physiological replacement of insulin: An elusive goal. New England Journal of Medicine 1989;321(6):363-70.