Insulin Lispro (Humalog®), A Novel Fast-Acting Insulin Analogue For The Treatment Of Diabetes Mellitus: Overview Of Pharmacological And Clinical Data

References

• 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 insulindependent diabetes mellitus. N Eng J Med 1993; 329: 977–986.
   Google Scholar
• Berger M, Cüppers HJ, Hegner H, et al. Absorption kinetics and biologic effects of subcutaneously injected insulin preparations. Diabetes Care 1982; 5: 577–591.
   Google Scholar
• American Diabetes Association. Clinical Practice Recommendations. Position statement: insulin administration. Diabetes Care 1997; 20 (Suppl 1): S46–S49
   Google Scholar
• Dimitriadis G, Gerich J. Importance of timing of preprandial subcutaneous insulin administration in the management of diabetes mellitus. Diabetes Care 1983; 6: 374–377.
   Google Scholar
• Lean MEJ, Tennison BR. Interval between insulin injection and eating in relation to blood glucose control in adult diabetics. Br Med J1985; 290: 105–108
   Google Scholar
• Jørgensen LN, Nielsen FS. Timing of premeal insulins in diabetic patients on a multiple daily injection regimen. A questionnaire study. Diabetologia 1990; 33: All6
   Google Scholar
• Holleman F, Hoekstra JBL. Insulin lispro. N Engl J Med 1997; 337: 176–183.
   Google Scholar
• Ciszak E, Beals JM, Frank BH, et al. Role of C-terminal B-chain residues in insulin assembly: The structure of hexameric ([Lys (B28), Pro(B29)])-human insulin. Structure 1995; 3: 615–622.
   Google Scholar
• Howey DC, Bowsher RR, Brunelle RL, Woodworth JR. ([Lys (BM28), Pro(BM29)])-human insulin. A rapidly absorbed analog of human insulin. Diabetes 1994; 43: 396–402.
   Google Scholar
• Dimarchi RD, Mayer JP, Fan L, et al. Synthesis of a fast-acting insulin based on structural homology with insulin-like growth factor I. Peptides: chemistry and biology. Proceedings of the Twelfth American Peptide Symposium. Smith JA, Rivier JE, eds. 1992; Leiden: ESCOM p 26–28.
   Google Scholar
• Dimarchi RD, Chance RE, Long HB, et al. Preparation of an insulin with improved pharmacokinetics relative to human insulin through consideration of structural homology with insulin-like growth factor 1. Horm Res 1994; 41 (Suppl 2): 93–96.
   Google Scholar
• Galloway JA, Chance RE. Approaches to insulin analogs. Diabetes 1994; Annual/8: Marshall SM, Home PD, eds. Amsterdam: Elsevier Science B.V. 277–297.
   Google Scholar
• Torlone E, Fanelli C, Rambotti AM, et al. Pharmacokinetics, pharmacodynamics and glucose counterregulation following subcutaneous injection of the monomeric insulin analogue Lys(BM28), Pro(BM29) in IDDM. Diabetologia 1994; 37: 713–720.
   Google Scholar
• Howey DC, Bowsher RR, Brunelle RL, et al. [Lys(BM28), Pro(BM29)]-human insulin: effect of injection time on postprandial glycemia. Clin Pharm Ther 1995; 58: 459–469.
   Google Scholar
• Woodworth J, Howey D, Bowsher R. [Lys(BM28), Pro(BM29)]- human insulin (K): Dose-ranging vs. Humulin R (H). Diabetes 1993; 42 (suppl. 1): 54A
   Google Scholar
• Antsiferov M, Woodworth JR, Mayorow A, et al. Lower within patient variability in postprandial glucose excusion with lispro insulin analog compared with regular insulin. Diabetes 1995; 44 (suppl. 1): 214A.
   Google Scholar
• Ter Braak EW, Woodworth JR, Bianchi R, et al. Injection site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin. Diabetes Care 1996; 19:1437–1440.
   Google Scholar
• Buelke-Sam J, Byrd RA, Hoyt JA, Zimmerman JL. A reproductive and developmental toxicity study in CD rats of LY275585, [Lys(BM28), Pro(BM29)]-human insulin. J Am Coll Toxicol 1994; 13: 247–260.
   Google Scholar
• Zimmermann. Subchronic and chronic toxicity, and mutagenicity studies conducted with LysPro [Lys(BM28), Pro(BM29)] human insulin analog, LY275585. 15th International Diabetes Federation Congress 1994; 123.
   Google Scholar
• Zimmermann JL, Truex LL. A 12-month chronic toxicity study of LY275585 (human insulin analog) administered subcutaneously to Fischer 344 rats. Diabetes 1994; 43(suppl.1): 166A.
   Google Scholar
• Helton DR, Zimmermann JL, Heim A, et al. General pharmacology of insulin lispro in animals. Drug Res 1996; 46: 91–97.
   Google Scholar
• Diamond T et al. Possible adverse fetal effect of insulin lispro. N Engl J Med 1997; 337: 1009–1010.
   Google Scholar
• Fineberg SE, Fineberg NS, Anderson JH, Burkitt M. Does the use of short-acting (LysPro) human insulin in insulin naive patients augment the insulin immune response or differ between type I and type II patients? Diabetes 1995; 44 (Suppl 1): 231 A.
   Google Scholar
• Fineberg NS, Fineberg SE, Anderson JH, et al. Immunologic effects of insulin lispro [ Lys (BM28), Pro (BM29) human insulin] in IDDM and NIDDM patients previously treated with insulin. Diabetes 1996; 45: 1750–54.
   Google Scholar
• Lahtela JT, Knip M, Paul R, et al. Severe antibody-mediated human insulin resistance: successful treatment with the insulin analog lispro: a case report. Diabetes Care 1997; 20(Suppl 1): 71–73.
   Google Scholar
• Kumar D. Lispro analog for treatment of generalized allergy to human insulin. Diabetes Care 1997; 20: 1357–1359
   Google Scholar
• Hermoso F, Vazquez M, Ghaves et al. Generalized allergy to human insulin treated with insulin lispro. Diabetologia 1997; 40 (Suppl 1): A349.
   Google Scholar
• Tsui Eyl et al. Counterregulatory hormone responses after longterm continuous subcutaneous insulin infusion with lispro insulin. Diabetes Care 1998; 21: 93–96.
   Google Scholar
• Jacobs MAJM, Salobir B, Popp-Snijders C, et al. Counterregulatory hormone responses and symptoms during hypoglycaemia induced by porcine, human regular insulin, and lys(BM28), pro(BM29) human insulin analogue (insulin lispro) in healthy male volunteers. Diabet Med 1997; 14: 248–257.
   Google Scholar
• Heineman L, Heise T, Wahl LCH, et al. Prandial glycaemia after a carbohydrate-rich meal in type 1 diabetic patients: using the rapid acting insulin analogue [lys(BM28), pro(BM29)] human insulin. Diabet Med 1996; 13: 625–629.
   Google Scholar
• Schernthaner G., Wolfgang W., Sandholzer K., et al. Postprandial insulin lispro: A new option in type 1 diabetic patients. Diabetes 1997; 46 (Suppl. 1): 98A.
   Google Scholar
• Anderson JH, Brunelle RL, Koivisto VA, et al Improved mealtime treatment of diabetes mellitus using insulin analogue. Clin Ther 1997; 19: 62–72.
   Google Scholar
• Anderson JH, Brunelle RL, Koivisto VA, et al. Reduction of postprandial hyperglycaemia and frequency of hypoglycaemia in IDDM patients on insulin analog treatment. Diabetes 1997; 46: 265–270.
   Google Scholar
• Anderson JH, Brunelle RL, Keohane p, et al. Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycaemia in NIDDM patients. Arch Intern Med 1997; 157: 1249–1255.
   Google Scholar
• Strachan MJ, Frier BM. Optimal time of administration of insulin lispro. Diabetes Care 1998; 21: 26–31.
   Google Scholar
• Stiller R, Gudat U, Pfuetzner A, et al. Letter to editor: postprandial treatment with insulin lispro. Diabetes and Metabolism 1997; 23: 232–33.
   Google Scholar
• Burge MR, Waters DL, Holcombe JH, Schade DS. Prolonged efficacy of short acting insulin lispro in combination with human ultralente in insulin-dependent diabetes mellitus. J Clin Endocrinol Metab 1997; 82: 920–924.
   Google Scholar
• Clore J, Woodworth JR, Cerimele BJ, et al. Mixing insulin lispro (lp) with ultralente (u) insulin does not result in decreased or delayed lp absorption. Diabetes 1997; 46 (Suppl 1): 150A.
   Google Scholar
• Bastyr EJ, Holcombe JH, Anderson JA, Clore JN. Mixing insulin lispro and ultralente insulin (Letter). Diabetes Care 1997; 20: 1047–1048.
   Google Scholar
• Stonny J, Burakowska A, Woodworht J, et al. The action profile of lispro is not blunted by mixing in the syringe with NPH. Diabetes 1997; 46 (Suppl 1): 166A.
   Google Scholar
• Heise T, Weyer C, Serwas A, et al. Time-action profiles of premixed formulations of insulin lispro and NPL-insulin. Diabetes 1997; 46 (Suppl 1): 152A.
   Google Scholar
• Holleman F, Schmitt H, Rottiers R, et al. Reduced frequency of severe hypoglycaemia and coma in well-controlled IDDM patients treated with insulin lispro. Diabetes Care 1997; 20: 1827–1832.
   Google Scholar
• Vignati L, Anderson JH JR.., Iversen PW. Efficacy of Insulin Lispro in Combination with NPH Human Insulin, given twice per day in IDDM and NIDDM patients. Clin Ther 1997; 19: 62–72.
   Google Scholar
• Jacobs M, Keulen E, Kane K, et al. Metabolic efficacy of preprandial administration of Lys(BM28),Pro(BM29) Human insulin analog in IDDM patients. Diabetes Care 1997; 20:1279–1286.
   Google Scholar
• Ebeling P, Jansson PA, Schmitt U, et al. Strategies toward improved control with insulin lispro therapy in IDDM: importance of basal insulin. Diabetes Care 1997; 20: 1287–1292.
   Google Scholar
• Sindaco P, Ciofetta M, Lalli C, et al. Importance of basal insulin in intensive treatment of IDDM with lispro insulin. Diabetes 1997; 46 (Suppl. 1): 331 A.
   Google Scholar
• Torlone E, Pampanelli S, Lalli C et al. Effects of the short-acting insulin analog [Lys(BM28),Pro(BM29)] on postprandial blood glucose control in IDDM. Diabetes Care 1996; 19: 945–952.
   Google Scholar
• Zinman B, Chiasson JL, Tildesley H, et al. Insulin lispro in CSII: results of a double-blind crossover study. Diabetes 1997; 46; 440–443.
   Google Scholar
• Hanaire H, Bringer J, Lassmann-Vague V, et al. Improvement of HbA1c without increasing hypoglycaemia risk in diabetic patients treated with insulin lispro in external pumps. Diabetologia 1997; 40 (Suppl 1):A10.
   Google Scholar
• Pfützner A, Renner R, The German Humalog CSII Study Group. CSII therapy with insulin pumps using insulin lispro. Diabetes 1997; 46 (Suppl 1): 34A.
   Google Scholar
• Pramming S, Thorsteinsson B, Bendtson I, Binder C. Symptomatic hypoglycemia in 411 type 1 diabetic patients. DiabetMed 1991; 8: 217–222.
   Google Scholar
• Reichard P, Berglund B, Britz A, Cars I, Nilsson BY, Rosenqvist U. Intensified conventional insulin treatment retards the microvascular complications of insulin-dependent diabetes mellitus (IDDM): the Stockholm Diabetes Intervention Study (SDIS) after 5 years. J Intern Med 1991; 230: 101–108.
   Google Scholar
• Macleod KM, Hepburn DA, Frier BM. Frequency and morbidity of severe hypoglycemia in insulin-treated diabetic patients. Diabet Med 1993; 10: 238–245.
   Google Scholar
• The DCCT Research Group. Epidemiology of severe hypoglycemia in the Diabetes Control and Complications Trial. Am J Med 1991; 90: 450–459.
   Google Scholar
• Wredling RAM, Töres Theorell PG, Roll HM, Lins PES, Adamson UKC. Psychosocial state of patients with IDDM prone to recurrent episodes of severe hypoglycemia. Diabetes Care 1992; 15: 518–521.
   Google Scholar
• Hermans MP, Genot Y, Buysschaert M. The cost of severe hypoglycaemic episodes in a cohort of insulin-dependent diabetic subjects admitted to St. Luc Hospital over the 1994-96 period. Arch Publ Health 1997; 55: 16.
   Google Scholar
• Holcombe J, Zalani S, Arora V, et al. Insulin lispro (LP) results in less nocturnal hypoglycaemia compared with regular human insulin in adolescents with type I diabetes. Diabetes 1997; 46 (Suppl 1): 103A.
   Google Scholar
• Ahmed ABE, Home PD. The effect of the insulin analog insulin lispro on nighttime blood glucose control in type 1 diabetic patients. Diabetes Care 1998; 21: 32–37.
   Google Scholar
• De Leeuw I, Rutters A, Schmitt, et al. [(Iys(BM28), pro(BM29)] human insulin (LysPro): Patients treated with LysPro vs. Human regular insulin: Quality of live assessment (QOL). 15th International Diabetes Federation Congress 1994; 253.
   Google Scholar
• Kotsanos JG, Vignati L, Huster W 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.
   Google Scholar
• Tuominen JA, Karonen SL, Melamies L, et al. Exercise-induced hypoglycaemia in IDDM patients treated with a short-acting insulin analogue. Diabetologia 1995; 38: 106–111.
   Google Scholar
• Demirdjian S, Savin S, Zirinis P, et al. Stability of insulin lispro in external and implantable insulin pump conditions. Diabetes 1997; 46 (suppl. 1): 152A.
   Google Scholar
• Renard E, Vague V, Pinget M, et al. SC infusion of insulin lispro vs. human regular insulin by portable pumps: significant improvement of HbA^ and blood glucose stability under insulin lispro. Diabetes 1997; 46 (Suppl 1): 157A.
   Google Scholar
• Hoss I, Salgado M, Sternberg F, et al. Insulin lispro improves glycemic control in IDDM patients under continuous subcutaneous insulin infusion (CSII). Diabetologia 1997; 40 (Suppl 1): A335.
   Google Scholar
• Schauss S, Konig A, Landgraf R. Human insulin analogue [Lys(BM28),Pro(BM29)]: The ideal pump insulin? Diabetic Medicine 1998; 15: 247–249.
   Google Scholar
• Rutledge KS, Chase HP, Klingensmith GJ et al. Effectiveness of postprandial Humalog in toddlers with diabetes. Pediatrics 1997; 100: 968–972.
   Google Scholar
• Garg SK, Carmain ja, Braddy KC et al. Pre-meal insulin analogue insulin lispro vs Humulin R insulin treatment in young subjects with Type 1 diabetes. Diabetic Med 1996; 13: 47–52.
   Google Scholar
• Holcombe J, Zalani S, Arora V, et al. Patient preference for insulin lispro versus Humulin R in adolescents with type I diabetes. Diabetologia 1997; 40 (Suppl 1): A343.
   Google Scholar
• Jovanovic L, Ilic SS, Gutierrez M, Bastyr III EJ. Insulin lispro improves postprandial glucose without increased immunogenicity or hypoglycaemia in gestational diabetic women. Diabetes 1998; (Suppl) 49A.
   Google Scholar
• Rosen SG, Engel SS. Use of insulin lispro in pregnant women with diabetes mellitus. Diabetes 1998; (Suppl) 437A.
   Google Scholar
• Bex M, Buysschaert M, De Leeuw I. De Schepper J, Fery F, Hermans MP, Keymeulen B, Lauvaux JP, Letiexhe M, Mathieu C, Nobels F, Rottiers R, Scheen A, Schmitt H, Van Crombrugge P, Van Gaal L. Insulin lispro (Humalog®) in the treatment of diabetes mellitus: overview of Belgian clinical data from global studies. Acta Clin Belg 1999; 54: 241–245.
   Google Scholar
• Nobels FR, Hermans MP, De Leeuw I. Insulin lispro (Humalog®): a novel fast-acting insulin analogue: guidelines for its practical use. Acta Clin Belg 1999; 54: 246–254
   Google Scholar
• Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M. Intensive insulin therapy prevents the progression of diabetic microvas-cular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 28: 103-117, 1995.
   Google Scholar
• Avignon A, Radauceanu A, Monnier L. Nonfasting plasma glucose is a better marker of diabetic control than fasting plasma glucose in type 2 diabetes. Diabetes Care 20:1822–1826, 1997.
   Google Scholar
• Ceriello A. The emerging role of post-prandial spikes in the pathogenesis of diabetic complications. Diabetic Med 15: 188–193, 1998.
   Google Scholar
• Haffner SM. The importance of hyperglycaemia in the non-fasting state to the development of cardiovascular disease. Endocrine Rev: 19: 583–592, 1998.
   Google Scholar