Journal of Diabetes and Its Complications
Volume 20, Issue 3 , Pages 145-152 , May 2006

Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: A randomized controlled trial in patients with type 2 diabetes beginning insulin therapy

  • Christof Kazda

      Affiliations

    • Lilly Deutschland GmbH, Bad Homburg, Germany
    • Corresponding Author InformationCorresponding author. Tel.: +49 0 6172 273 961; fax: +49 0 6172 273 2182.
    • ,
  • Hiltrud Hülstrunk

      Affiliations

    • Lilly Deutschland GmbH, Bad Homburg, Germany
    • ,
  • Karin Helsberg

      Affiliations

    • Lilly Deutschland GmbH, Bad Homburg, Germany
    • ,
  • Frank Langer

      Affiliations

    • Lilly Deutschland GmbH, Bad Homburg, Germany
    • ,
  • Thomas Forst

      Affiliations

    • Institute for Clinical Research and Development, Mainz, Germany
    • ,
  • Markolf Hanefeld

      Affiliations

    • Center for Clinical Studies, GWT Technical University, Dresden, Germany

Received 18 April 2005 ,Revised 1 September 2005 ,Accepted 19 September 2005.

References 

  1. American Diabetes Association . Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2001;24(Suppl. 1):S33–S43
  2. American Diabetes Association . Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2004;27(Suppl. 1):S15–S35
  3. 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;157:1249–1255
  4. Bastyr EJ, Stuart CA, Brodows RG, Schwartz S, Graf CJ, Zagar A, et al. Therapy focused on lowering postprandial glucose, not fasting glucose, may be superior for lowering HbA1c. Diabetes Care. 2000;23:1236–1241
  5. Bonora E, Muggeo M. Postprandial blood glucose as a risk factor for cardiovascular disease in type II diabetes: The epidemiological evidence. Diabetologia. 2002;44:2107–2114
  6. Bruttomesso D, Pianta A, Mari A, Valerio A, Marescotti MC, Avogaro A, et al. Restoration of early rise in plasma insulin levels improves the glucose tolerance of type 2 diabetic patients. Diabetes. 1999;48:99–105
  7. Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003;52:102–110
  8. Campbell RK, White JR. Insulin therapy in type 2 diabetes. Journal of the American Pharmaceutical Association (Washington, D. C.: 1996). 2002;42:602–611
  9. DeVeciana M, Major CA, Morgan MA, Asrat T, Toohey JS, Lien JM, et al. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. New England Journal of Medicine. 1995;333:1237–1241
  10. Feinglos MN, Thacker CH, English J, Bethel MA, Lane JD. Modification of postprandial hyperglycemia with insulin lispro improves glucose control in patients with type 2 diabetes. Diabetes Care. 1997;20:1539–1542
  11. Forst T, Kunt T, Kazda Ch, Lobisch M, Pfützner A. Die rolle der protein kinase C in der entwicklung mikrovaskulärer komplikationen des diabetes mellitus. Diabetes und Stoffwechsel. 2002;11:62–70
  12. Gastaldelli A, Ferrannini E, Miyazaki Y, Matsuda M, DeFronzo RA. Beta-cell dysfunction and glucose intolerance: Results from the San Antonio Metabolism (SAM) study. Diabetologia. 2004;47:31–39
  13. Gerich JE. Clinical significance, pathogenesis, and management of postprandial hyperglycemia. Archives of Internal Medicine. 2003;163:1306–1316
  14. Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, et al. Risk factors for myocardial infarction and death in newly detected NIDDM: The Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996;39:1577–1583
  15. Hanefeld M, Temelkova-Kurktschiev T, Schaper F, Henkel E, Siegert G, Koehler C. Impaired fasting glucose is not a risk factor for atherosclerosis. Diabetic Medicine. 1999;16:212–218
  16. Hanefeld M, Koehler C, Schaper F, Fuecker K, Henkel E, Temelkova-Kurktschiev T. Postprandial plasma glucose is an independent risk factor for increased carotid intima-media thickness in non-diabetic individuals. Atherosclerosis. 1999;144:229–335
  17. Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care. 2000;23:644–649
  18. Heise T, Heinemann L. Rapid and long-acting analogues as an approach to improve insulin therapy: An evidence-based medicine assessment. Current Pharmaceutical Design. 2001;7:303–1325
  19. 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;22:1607–1611
  20. HOE 901/2004 Study Investigators Group. Safety and efficacy of insulin glargine (HOE 901) versus NPH insulin in combination with oral treatment in type 2 diabetic patients. Diabetic Medicine. 2003;20:545–551
  21. Kalfhaus J, Berger M. Insulin treatment with preprandial injections of regular insulin in middle-aged type 2 diabetic patients. A two years observational study. Diabetes and Metabolism. 2000;26:197–201
  22. Kotsanos JG, Vignati L, Huster W, Andrejasich C, Boggs MB, Jacobson AM, et al. Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy. Diabetes Care. 1997;20:948–958
  23. LeRoith D. Beta-cell dysfunction and insulin resistance in type 2 diabetes: Role of metabolic and genetic abnormalities. American Journal of Medicine. 2002;113(Suppl. 6A):3–11
  24. Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, et al. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004;27:2597–2602
  25. Mäkimattila S, Nikkilä K, Yki-Järvinen H. Causes of weight gain during insulin therapy with and without metformin in patients with type II diabetes mellitus. Diabetologia. 1999;42:406–412
  26. Milicevic Z, Raz I, Strojek K, Skrha J, Tan MH, Wyatt JW, et al. The HEART2D Study: Hyperglycemia and its effect after acute myocardial infarction (MI) on cardiovascular (CV) outcomes in patients with type 2 diabetes. Abstract 2650 Diabetes and Metabolism. 2003;29(4S):339
  27. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: Variations with increasing levels of HbA(1c). Diabetes Care. 2003;26:881–885
  28. Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: A randomized prospective 6-year study. Diabetes Research and Clinical Practice. 1995;28:103–117
  29. Reviriego J, Millan M. Health-related quality of life and insulin lispro. A naturalistic approach. Diabetes Care. 1998;21:1203–1204
  30. Riddle MC, Rosenstock J, Gerich J, Insulin Glargine 4002 Study Investigators . The treat-to-target trial: Randomised addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26:3080–3086
  31. Roach P, Trautmann M, Arora V, Sun B, Anderson JH and the Mix 50 Study Group. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro Mix 25 and insulin lispro Mix 50. Clinical Therapeutics. 1999;21:523–534
  32. Rosenstock J, Park G, Zimmerman J U.S. Insulin Glargine (HOE 901) Type 1 Diabetes Investigator Group. Basal insulin glargine (HOE 901) versus NPH insulin in patients with type 1 diabetes on multiple daily insulin regimens. Diabetes Care. 2000;23:1137–1142
  33. 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
  34. 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. Clinical and Investigative Medicine. 2001;24:292–298
  35. Sheetz MJ, King GL. Molecular understanding of hyperglycemia's adverse effects for diabetic complications. Journal of the American Medical Association. 2002;288:2579–2588
  36. Skyler J. Approach to hyperglycemia in the patient with diabetes mellitus; therapeutic objectives in type I diabetes. In:  Humes HD,  DuPont HL, et al. editor. Kelley's textbook of intern medicine. Philadelphia: Lippincott Williams & Wilkins; 2000;p. 2635–2648
  37. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study. British Medical Journal. 2000;321:405–412
  38. Temelkova-Kurktschiev TS, Koehler C, Henkel E, Leonhardt W, Fuecker K, Hanefeld M. Postchallenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. Diabetes Care. 2000;23:1830–1834
  39. United Kingdom Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–853
  40. Yki-Järvinen 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

☆ This study was supported by grants from Lilly Deutschland GmbH, Bad Homburg, Germany.

PII: S1056-8727(05)00124-8

doi: 10.1016/j.jdiacomp.2005.09.004

Journal of Diabetes and Its Complications
Volume 20, Issue 3 , Pages 145-152 , May 2006

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