Diabetes Research and Clinical Practice
Volume 77, Issue 1 , Pages 1-15 , July 2007

A review of human and analogue insulin trials

Received 24 April 2006 ,Accepted 13 October 2006.

References 

  1. Plank J, Siebenhofer A, Berghold A, Jeitler K, Horvath K, Mrak P, et al. Systematic review and meta-analysis of short-acting insulin analogues in patients with diabetes mellitus. Arch. Intern. Med. 2005;165:1337–1344
  2. A. Siebenhofer, J. Plank, A. Berghold, M. Narath, R. Gfrerer, T. Pieber, Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus, Cochrane Database Syst. Rev. 18 (2004) CD003287.
  3. Pfutzner A, Kustner E, Forst T. Intensive insulin therapy with insulin lispro in patients with type 1 diabetes reduces the frequency of hypoglycemic episodes. Exp. Clin. Endocrinol. Diabetes. 1996;104:25–30
  4. Anderson JH, Brunelle RL, Koivisto VA, Pfutzner A, Trautmann ME, Vignati L, et al. Reduction of postprandial hyperglycaemia and frequency of hypoglycaemia in IDDM patients on insulin-analog treatment. Diabetes. 1997;46:265–270
  5. Anderson JH, Brunelle RL, Koivisto VA, Trautmann ME, Vignati L, DiMarchi R. Improved mealtime treatment of diabetes mellitus using an insulin analogue. Clin. Ther. 1997;19:62–72
  6. 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. The Benelux-UK Insulin Lispro Study Group. Diabetes Care. 1997;20:1827–1832
  7. Heller SR, Amiel SA, Mansell P. Effect of the fast-acting insulin analog lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. U.K. Lispro Study Group. Diabetes Care. 1999;22:1607–1611
  8. Holcombe JH, Zalani S, Arora VK, Mast CJ Lispro in Adolescents Study Group. Comparison of insulin lispro with regular human insulin for the treatment of type 1 diabetes in adolescents. Clin. Ther. 2002;24:629–638
  9. Valle D, Santoro D, Bates P, Scarpa L Italian Multicentre Lispro Study Group. Italian multicentre study of intensive therapy with insulin lispro in 1184 patients with Type 1 diabetes. Diabetes Nutr. Metab. 2001;14:126–132
  10. Home P, 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
  11. Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, et al. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res. Clin. Pract. 2006;71:131–139
  12. Raskin P, Guthrie R, Leiter L, Riis A, Jovanic 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;23:583–588
  13. Heller SR, Colagiuri S, Vaaler S, Wolffenbuttel BH, Koelendorf K, Friberg HH, et al. Hypoglycaemia with insulin aspart: a double-blind, randomized, crossover trial in subjects with type 1 diabetes. Diabet. Med. 2004;21:769–775
  14. 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
  15. Raskin P, Klaff L, Bergenstal R, Halle JP, Donley D, Mecca T. 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
  16. Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA. Less hypoglycaemia with IGlarg in intensive insulin therapy for type 1 diabetes. Diabetes Care. 2000;23:639–643
  17. Porcellati F, Rossetti P, Pampanelli S, Fanelli CG, Torlone E, Scionti L, et al. Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with type 1 diabetes mellitus given meal-time lispro insulin. Diabet. Med. 2004;21:1213–1220
  18. Schober E, Schoenle E, Van Dyk J, Wernicke-Panten K Pediatric Study Group of Insulin Glargine. Comparative trial between insulin glargine and NPH insulin in children and adolescents with type 1 diabetes. Diabetes Care. 2001;24:2005–2006
  19. Fulcher GR, Gilbert RE, Yue DK. Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy. Intern. Med. J. Sep. 2005;35(9):536–542
  20. Home PD, Rosskamp R, Forjanic-Klapproth J, Dressler A European Insulin Glargine Study Group. 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
  21. Vague P, Selam JL, Skeie S, De Leeuw I, Elte JW, Haahr H, 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;26:590–596
  22. De Leeuw I, Vague P, Selam J-L, Skeie S, Lang H, Draeger E, et al. Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obes. Metab. 2005;7:73–82
  23. Standl E, Lang H, Roberts A. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technol. Ther. 2004;6:579–588
  24. Pieber TR, Draeger E, Kristensen A, Grill V. Comparison of three multiple injection regimens for Type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin. Diabet. Med. 2005;22:850–857
  25. Home P, Bartley P, Russell-Jones D, Hanaire-Broutin H, Heeg JE, Abrams P, 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;27:1081–1087
  26. Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin. Ther. 2004;26:724–736
  27. Kolendorf K, Prasek M, Santeusanio F. Insulin detemir is associated with lower risk of hypoglycaemia compared to NPH insulin in people with type 1 diabetes. Diabetologia. 2004;47(Suppl. 1):A329;(Abstract)
  28. Robertson K, Schönle E, Gucev Z, Mordhorst L, Tamer S, Gall M-A, et al. Benefits of insulin detemir over NPH insulin in children and adolescents with type 1 diabetes: lower and more predictable fasting plasma glucose and lower risk nocturnal hypoglycaemia. Diabetolgia. 2004;47(Suppl. 1):A32;(Abstract)
  29. Hermansen K, Fontaine P, Kukolja K, Peterkova V, Leth G, Gall M-A. 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
  30. K. Raslova, M. Bogoev, I. Raz, G. Leth, M.A. Gall, N. Hancu, Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes, Diabetes Res. Clin. Pract. 66 (2004) 193–201See also Erratum, Diabetes Res. Clin. Pract., 72 (1) 2006 112.
  31. Haak T, Tiengo A, Draeger E, Suntum M, Waldhausl W. 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
  32. Hermansen K, Derezinski T, Kim H, Gall M-A. Treatment with insulin detemir in combination with oral agents is associated with less risk of hypoglycaemia and less weight gain than NPH insulin at comparable levels of glycaemic improvement in people with type 2 diabetes. Diabetologia. 2004;47(Suppl. 1):A273;(Abstract)
  33. Yki-Jarvinen H, Dressler A, Ziemen M HOE 901/300s Study Group. 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;23:1130–1136
  34. Rosenstock J, Schwartz SL, Clark CM, Park GD, Donley DW, Edwards MB. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care. 2001;24:631–636
  35. Fritsche A, Schweitzer MA, Häring H-U. 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
  36. Riddle M, Rosenstock J, Gerich J. 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
  37. Eliaschewitz FG, Calvo C, Valbuena H, Ruiz M, Aschner P, Villena J, et al. Latin American clinical trial project on insulin glargine versus NPH plus glimepiride in type 2 diabetes. Diabetologia. 2003;46(Suppl. 2):A273;(Abstract)
  38. Heise T, Nosek L, Ronn BB, Endahl L, Heinemann L, Kapitza C, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes. 2004;53:1614–1620
  39. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients. Diabetes Care. 2003;26:881–885
  40. Ashwell S, Amiel S, Bilous R, Dashora U, Heller SR, Hepburn DA, et al. Improved blood glucose control with insulin glargine plus insulin lispro in comparison with NPH insulin plus unmodified human insulin in people with type 1 diabetes. Diabet. Med. 2006;23:285–292
  41. Murphy NP, Keane SM, Ong KK, Ford-Adams M, Edge JA, Acerini CL, et al. Randomized cross-over trial of insulin glargine plus lispro or NPH insulin plus regular human insulin in adolescents with type 1 diabetes on intensive insulin regimens. Diabetes Care. 2003;26:799–804
  42. Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet. Med. 2002;19:393–399
  43. Boehm BO, Vaz JA, Brønstedt L, Home PD. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur. J. Intern. Med. 2004;15:496–502
  44. Roach P, Yue L, Arora V. Improved postprandial glycemic control during treatment with Humalog Mix25, a novel protamine-based insulin lispro formulation. Humalog Mix25 Study Group. Diabetes Care. 1999;22:1258–1261
  45. McNally P, Fitch M, Nelson G. Patients with type 2 diabetes mellitus have lower rates of nocturnal hypoglycaemia on biphasic insulin aspart (BIAsp 30) than on biphasic human insulin-30 (BHI30): data from the REACH study. Diabetologia. 2004;47(Suppl. 1):A327;(Abstract)
  46. Iwamoto Y. A randomised, multicentre trial of biphasic insulin aspart versus biphasic human insulin in type 2 diabetes. Diabetologia. 2003;46(Suppl. 2):A270;(Abstract)
  47. Massi Benedetti M, Humburg E, Dressler A, Ziemen M. 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
  48. Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care. 2005;28:950–955
  49. Anderson JH, Brunelle RL, Keohane P, Koivisto VA, Trautmann ME, Vignati L, et al. Multicenter Insulin Lispro Study Group Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Arch. Intern. Med. 1997;157:1249–1255
  50. Ross SA, Zinman B, Campos RV, Strack T Canadian Lispro Study Group. A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents. Clin. Invest. Med. 2001;24:292–298
  51. 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
  52. Brunelle BL, Llewelyn J, Anderson JH, Gale EA, Koivisto VA. Meta-analysis of the effect of insulin lispro on severe hypoglycemia in patients with type 1 diabetes. Diabetes Care. 1998;21:1726–1731
  53. Heller S, Kim H, Draeger E. Within-person variation in fasting blood glucose is correlated to incidence of hypoglycaemia in people with type 1 diabetes treated with insulin detemir and NPH insulin. Diabetes. 2004;53(Suppl. 2):A486;(Abstract)
  54. Ceriello A. Postprandial hyperglycemia and diabetes complications: is it time to treat?. Diabetes. 2005;54:1–7
  55. DECODE Study Group on Behalf of the European Diabetes Epidemiology Group. Glucose tolerance and mortality: comparison of WHO and American Diabetic Association diagnostic criteria. Lancet. 1999;354:617–621
  56. Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M STOP-NIDDM Trial Research Group. Acarbose treatment and the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance: the STOP-NIDDM trial. JAMA. 2003;290:486–494
  57. American Association of Clinical Endocrinologists, Implementation Conference for ACE Outpatient Diabetes Mellitus Consensus Conference Recommendations: Position Statement, 2005, Available from http://www.aace.com/meetings/consensus/odimplementation/PositionStatement.pdf, accessed 9 December 2005.
  58. American Association of Clinical Endocrinologists Road Map to Achieve Glycaemic Goals, 2005, Available from http://www.aace.com/meetings/consensus/odimplementation/roadmap.pdf, accessed 9 December 2005.
  59. Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, et al. Initiating insulin therapy in type 2 diabetes. Diabetes Care. 2005;28:260–265
  60. Diabetes Control and Complications Trial Research Group. Hypoglycaemia in the diabetes control and complications trial. Diabetes. 1997;46:271–286
  61. Tamas G, Marre M, Astorga R, Dedov I, Jacobsen J, Lindholm A Insulin Aspart Study Group. Glycaemic control in Type 1 diabetic patients using optimized insulin aspart or human insulin in a randomized multinational study. Diabetes Res. Clin. Pract. 2001;54:105–114
  62. Heinemann L. Do insulin-treated diabetic patients use an injection-meal-interval in daily life?. Diabet. Med. 1995;12:449–450
  63. 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. Diabet. Med. 2000;17:371–375
  64. Dunn CJ, Plosker GL. Insulin lispro: a pharmacoeconomic review of its use in diabetes mellitus. Pharmacoeconomics. 2002;20:989–1025
  65. 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. Diabet. Med. 2003;20:626–634

☆ The author has received honoraria for lectures and meeting attendance from Novo Nordisk, Eli Lilly, Sanofi Aventis and Pfizer.

PII: S0168-8227(06)00486-4

doi: 10.1016/j.diabres.2006.10.015

Diabetes Research and Clinical Practice
Volume 77, Issue 1 , Pages 1-15 , July 2007

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