Insulin aspart: promising early results borne out in clinical practice

REFERENCES

• GAMMELTOFT S, FALCK HANSEN B, DIDERIKSEN L et al: Insulin aspart: a novel rapid-acting human insulin analogue. Expert Opin. Investig. Drugs (1999) 8(9):1431–1441. •Early review of IAsp, containing primarily preclinical data.
   Google Scholar
• DCCT RESEARCH GROUP: The effectof intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Eriglj Med. (1993) 329:977–986.
   PubMed Web of Science ®Google Scholar
• UKPDS GROUP: Intensive blood glucosecontrol 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.
   PubMed Web of Science ®Google Scholar
• UKPDS GROUP: Effect of intensive blood glucose control with metformin on complications in overweight patients with Type 2 diabetes (UKPDS 34). Lancet (1998) 352:854–865.
   PubMed Web of Science ®Google Scholar
• STRATTON I, ADLER A, NEIL H et al: Association of glycaemia with macrovascular and microvascular complications of Type 2 diabetes (UKPDS 35): prospective observational study. Br. Med. 1 (2000) 32(7258):405–412.
   Google Scholar
• HANEFELD M, FISCHER S, JULIUS U 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.
   PubMed Web of Science ®Google Scholar
• HAFFNER S: The importance of hyperglycaemia in the non-fasting state to the development of cardiovascular disease. Endocr. Rev (1998) 19(5):583–592.
   PubMed Web of Science ®Google Scholar
• BALKAU B, SHIPLEY M, JARRETT R et al.: High blood glucose concentration is a risk factor for mortality in middle-aged men. 20-year follow-up in the Whitehall Study, the Paris Prospective Study and the Helsinki Policemen Study. Diabet. Care (1998) 21:360–367.
   Google Scholar
• TOMINAGA M, EGUCHI H, MANAKA H, IGARASHI K, KATO T, SEKIKAWA A: Impaired glucose tolerance is a risk factor for cardiovascular disease but not impaired fasting glucose. The Funagata Diabetes Study. Diabet. Care (1999) 22(6):920–924.
   PubMed Web of Science ®Google Scholar
• THE DECODE STUDY GROUP EUROPEAN DIABETES EPIDEMIOLOGY GROUP: Diabetes epidemiology: collaborative analysis of diagnostic criteria in Europe. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. Lancet (1999) 354(9179):617–621.
   Google Scholar
• HALLER H: Postprandial glucose and vascular disease. Diabet. Med. (1997) 14:S50–S56.
   Web of Science ®Google Scholar
• CERIELLO A: The emerging role of post-prandial hyperglycaemic spikes in the pathogenesis of diabetic complications. Diabet. Med. (1998) 15:188–193.
   PubMed Web of Science ®Google Scholar
• LEFEBVRE P, SCHEEN A: The postprandial state and risk of cardiovascular disease. Diabet. Med. (1998) 15(4):563–S68.
   Google Scholar
• BRANGE J, RIBEL U, HANSEN J et al:Monomeric insulins and their experimental and clinical implications. Nature (1988) 333:679–682.
   PubMed Web of Science ®Google Scholar
• DIMITRIADIS G, GERICH J: Importance of timing of preprandial sc. insulin administration in the management of diabetes mellitus. Diabet. Care (1983) 6(4):374–377.
   PubMed Web of Science ®Google Scholar
• LEAN M, NG LL, TENNISON B: Interval between insulin injection and eating in relation to blood glucose control in adult diabetics. Br Med.j. Clirr. Res. Ed. (1985) 290(6462):105–108.
   PubMedGoogle Scholar
• KURTZHALS P, SCHAFFER L, DREJER K, HANSEN B: Insulin receptor tyrosine kinase activation by insulin aspart and insulin analogues with a wide range of receptor binding affinities. Diabetologia (1999) 42\(Suppl. 1):A179.
   Google Scholar
• SLIEKER L, BROOKE G, DIMARCHI R et al: Modifications in the B10 and B26-30 regions of the B chain of human insulin alter affinity for the human IGF-1 receptor more than for the insulin receptor. Diabetologia (1997) 40: S54–S61.
   PubMed Web of Science ®Google Scholar
• TRIDB T, HEY A, SORENSEN A et al: Growth promoting activity of insulin aspart and other insulin analogues. Diabetologia (1999) 42\(Suppl. 1):A179. Abstract.
   Google Scholar
• HANSEN B, DANIELSEN G, DREJER K et al.: Sustained signalling from the insulin receptor after stimulation with insulin analogues exhibiting increased mitogenic potency. Biochem. J. (1996) 315:271–279.
   PubMed Web of Science ®Google Scholar
• HEINEMANN L, KAPITZA C, STARKE A, HEISE T: Time-action profile of the insulin analogue B28Asp. Diabet. Med. (1996) 13:683–684.
   PubMed Web of Science ®Google Scholar
• VOLUND A, BRANGE J, DREJER K et al.: In vitro and in vivo potency of insulin analogues designed for clinical use. Diabet. Med. (1991) 8(9):839–847.
   PubMed Web of Science ®Google Scholar
• DREJER K, KRUSE V, LARSEN U et al.: Receptor binding and tyrosine kinase activation by insulin analogues with extreme affinities studied in human hepatoma HepG2 cells. Diabetes (1991) 40(11):1488–1495.
   PubMed Web of Science ®Google Scholar
• KANG S, BRANGE J, BURCH A, VOLUND A, OWENS D: Absorption kinetics and action profiles of subcutaneously administered insulin analogues (A5pB9G1uB27, AspB10, AspB28) in healthy subjects. Diabet. Care (1991) 14(11):1057–1065.
   PubMed Web of Science ®Google Scholar
• KANG S, CREAGH F, PETERS J, BRANGE J, VOLUND A, OWENS D: Comparison of sc. soluble human insulin and insulin analogues (AspB9, G1uB27; AspB10; AspB28) on meal-related plasma glucose excursions in Type I diabetic subjects. Diabet. Care (1991) 14(7):571–577.
   Google Scholar
• HEINEMANN L, HEISE T, JORGENSEN L, STARKE A: Action profile of the rapid acting insulin analogue: human insulin B28Asp. Diabet. Med. (1993) 10(6):535–539.
   PubMed Web of Science ®Google Scholar
• HOME E LINDHOLM A, HYLLEBERG B, ROUND P: Improved glycaemic control with insulin aspart: a multicenter randomised double-blind crossover trial in Type 1 diabetic patients. Diabet. Care (1998) 21:1904-1909. •Sizeable study showing improved postprandial glycaemic control and fewer hypoglycaemic episodes with IAsp.
   Google Scholar
• LINDHOLM A, MCEWEN J, RIIS A: Improved postprandial glycaemic control with insulin aspart: a randomised double-blind crossover trial in Type 1 diabetes. Diabet. Care (1999) 22:801–805.
   PubMed Web of Science ®Google Scholar
• HEINEMANN L, WEYER C, RAUHAUS M, HEINRICHS S, HEISE T: Variability of the metabolic effect of soluble insulin and the rapid-acting insulin analog insulin aspart. Diabet. Care (1998) 21(11):1910–1914.
   PubMed Web of Science ®Google Scholar
• HOME E LINDHOLM A, RIIS A: Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomised controlled trial. Diabet. Med. (2000) 17:762-770. ••Large, long-term, prospective Europeanstudy, demonstrating HbAk reduction, lower postprandial glucose levels, reduced major nocturnal and late-postprandial hypoglycaemia and greater treatment satisfaction with IAsp.
   Google Scholar
• RASKIN P, GUTHRIE R, LETTER 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. Diabet. Cam (2000) 23(5):583–588. ••Large, long-term North American study,showing HbAk reduction and improved postprandial glycaemic control with IAsp compared with HI, with no increased hypoglycaemic risk.
   Google Scholar
• HOOGWERF B, RASKIN E JOVANOVIC L et al: Insulin aspart - a mealtime alternative to soluble human insulin in Type 1 diabetes. Diabetologia (1999) 42\(Suppl. 1):A237.
   Google Scholar
• ZIMMERMANN J: A 12-month chronic toxicity study of LY-275585 (human insulin analog) administered subcutaneously to fischer-344 rats. Diabetes (1994) 43:A166–A166.
   Web of Science ®Google Scholar
• DREJER K: The bioactivity of insulin analogues from in vitro receptor binding to in vivo glucose uptake. Diabetes Metab. Rev (1992) 8:259–285.
   PubMed Web of Science ®Google Scholar
• KURTZHALS E SCHAFFER L, SORENSEN A et al: Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes (2000) 49:999-1005. •Provides data on receptor binding of IAsp and mitogenic and clinical potencies.
   Google Scholar
• MUDALIAR S, LINDBERG E JOYCE M et al: IAsp (B28 Asp-Insulin): a fast-acting analog of human insulin. Diabet. Care (1999) 22(9):1501–1506. •Recent pharmacokinetic/pharmaco-dynamic study.
   Google Scholar
• HOME E BARRIOCANAL L, LINDHOLM A: Comparative pharmacokinetics and pharmacodynamics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers. Eur: Pharmacol. (1999) 55:199-203. •Recent pharmacokinetic/pharmaco-dynamic study.
   Google Scholar
• BRAAK E, WOODWARD J, RUTGERT B et al: Injection site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin. Diabet. Care (1996) 12:1484–1493.
   Google Scholar
• JORGENSEN L, NIELSEN F: Timing of pre-meal insulins in diabetic patients on a multiple daily injection regiman: a questionnaire study. Diabetologia (1990) 33\(Suppl. 1):A116.
   Google Scholar
• PLUM A, AGERSO H, ANDERSEN L: Pharmacokinetics of the rapid-acting insulin analog, insulin aspart, in rats, dogs and pigs and pharmacodynamics of insulin aspart in pigs. Drug. Metab. Dispos. (2000) 28(2):155–160.
   PubMed Web of Science ®Google Scholar
• DE MEIJER E LUTTERMAN J, VAN LIER H, VAN'T LAAR A: The variability of the absorption of subcutaneously injected insulin: effect of injection technique and relation with brittleness. Diabet. Med. (1990) 7:499–505.
   PubMed Web of Science ®Google Scholar
• GALLOWAY J, SPRADLIN C, NELSONR, WENTWORTH S, DAVIDSON J, SWARNER J: Factors influencing the absorption, serum insulin concentration and blood glucose responses after injections of regular insulin and various insulin mixtures. Diabet. Care (1981) 4:366–376.
   PubMed Web of Science ®Google Scholar
• ZIEL F, DAVIDSON M, HARRIS M, ROSENBERG C: The variability in the action of unmodified insulin is more dependent on changes in tissue insulin sensitivity than on insulin absorption. Diabet. Med. (1988) 5:662–666.
   PubMed Web of Science ®Google Scholar
• HALBERG I, JACOBSEN L, DAHL U: A study on self-mixing insulin aspart with NPH insulin in the syringe before injection. Diabetes (1999) 48\(Suppl. 1):A104–A104.
   Google Scholar
• MORTENSEN H, LINDHOLM A, OLSEN B, HYELLEBERG B: Rapid appearance and onset of action of insulin aspart in paediatric subjects with Type 1 diabetes. Eur j Paediatr (2000) 159(7):483–488.
   PubMed Web of Science ®Google Scholar
• KAKU K, MATSUDA M, URAE A, IRIE S: Pharmacokinetics and pharmaco-dynamics of insulin aspart, a rapid-acting analog of human insulin, in healthy Japanese volunteers. Diabet. Res. OM. Pict. (2000) 49:119–126.
   PubMed Web of Science ®Google Scholar
• MEGYESI C, SAMOLS E, MARKS V: Glucose tolerance and diabetes in chronic liver disease. Lancet (1967) 2(7525):1051–1056.
   PubMed Web of Science ®Google Scholar
• CAVALLO-PERIN P, CASSADER M, BOZZO C et al: Mechanism of insulin resistance in human liver cirrhosis. Evidence of a combined receptor and postreceptor defect. J Clin. Invest. (1985) 75(5):1659–1665.
   Google Scholar
• LYNESS W, TYLER J, LAWRENCE A: Pharmacokinetics of the rapid-acting insulin analog, insulin aspart, is independent of hepatic function. Diabetes (2001) 50(2):A442.
   Google Scholar
• LYNESS W, TYLER J, LAWRENCE A: Renal impairment does not affect insulin aspart pharmacokinetics in Type 1 diabetes. Diabetes (2001) 50(2):A441.
   Google Scholar
• LYNESS W, TYLER J, LAWRENCE A: BMI does not affect insulin aspart pharmacokinetics in Type 1 diabetes. Diabetes (2001) 50(2):A124.
   Google Scholar
• RASKIN P, MCGILL J, KILO C, BOSS A: Insulin aspart is comparable to human insulin in Type 2 diabetes. Diabetes (1999) 48\(Suppl. 1):A355. Abstract 1554.
   Google Scholar
• BOTT U, EBRAHIM S, HIRSCHBERGER S, LEUKEL P, SIEBER J: Effect of the insulin analogue insulin aspart on quality-of-life and treatment satisfaction in Type 1 diabetic patients. Diabetes (1999) 48 (Suppl. 1): A112. Abstract 0481 (Submitted to Diabet. Med. May 2001).
   Google Scholar
• AMERICAN DIABETES ASSOCIATION: Clinical practice recommendations 1999. Diabet. Care (1999) 22\(Suppl. 1):S1–114.
   Google Scholar
• BRUNNER G, HIRSCHBERGER S, SENDLHOFER G et al.: Post-prandial administration of the insulin analogue insulin aspart in patients with Type 1 diabetes. Diabet Med. (2000) 17:371-375. ••Postprandial administration of IAsp is aviable option.
   Google Scholar
• ROSENFALCK A, THORSBY P, KJEMS L et al.: Improved postprandial glycaemic control with insulin aspart in Type 2 diabetic patients treated with insulin. Acta Diabetol. (2000) 37:41–46.
   PubMed Web of Science ®Google Scholar
• TAMAS G, MARRE M, ASTORGA R et al.: Glycaemic control in Type 1 diabetic patients using optimised insulin aspart or human insulin in a randomised multinational study. Accepted to Diabet. Res. Clin. Piaci (2001) 54:105–114.
   PubMed Web of Science ®Google Scholar
• DEVRIES J, LINDHOLM A, HEINE R, HOME E for the TRI-CONTINENTAL INSULIN ASPART STUDY GROUP: A randomized trial of insulin aspart with intensified basal NPH insulin supplementation in Type 1 diabetes. Diabetologia (2001) 44\(Suppl. 1):A209. Abstract.
   Google Scholar
• BODE B, STEED R, DAVIDSON P: Reduction in severe hypoglycaemia with long-term continuous sc. infusion in Type 1 diabetes. Diabet. Care (1996) 19(4):324–327.
   Google Scholar
• EICHNER H, SELAM J, HOLLEMAN C etal.: Reduction of severe hypoglycaemic events in Type 1 (insulin dependent) diabetic patients using continuous sc. insulin infusion. Diabet. Res. (1988) 8:189–193.
   Google Scholar
• SCHIFFERDECKER E, SCHMIDT K, BOEHM B, SCHATZ H: Long term compliance of intensified insulin therapy. Diabet. Res. Clin. Pict. (1994) 23:17–23.
   PubMed Web of Science ®Google Scholar
• DCCT RESEARCH GROUP: Implementation of treatment protocols in the Diabetes Control and Complications Trial. Diabet. Care (1995) 18:361–376.
   PubMed Web of Science ®Google Scholar
• BOLAND E, GRAY M, OESTERLE A, FREDRICKSON L, TAMBORLANE W: Continuous sc. insulin infusion: a new way to lower risk of severe hypoglycemia, improve metabolic control and enhance coping in adolescents with Type 1 diabetes. Diabet. Care (1999) 22:1779–1784.
   Google Scholar
• BODE B, STEED R, DAVIDSON P: Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in Type 1 diabetes. Diabet. Care (1996) 19:324–327.
   PubMed Web of Science ®Google Scholar
• BODE B, STRANGE P: Efficacy, safety and pump compatibility of insulin aspart used in continuous sc. insulin infusion therapy in patients with Type 1 diabetes. Diabet. Care (2001) 24(1):69–72. •IAsp is suitable for use in an external pump.
   Google Scholar
• BODE B, WEINSTEIN R, BELL D et al.: Insulin aspart efficacy and safety compared to buffered regular insulin (velosulin) and insulin lispro for continuous sc. insulin infusion. Diabetes (2001) 50(2):A106.
   Google Scholar
• RASKIN E BODE B, MARKS J etal.: Insulin aspart is as effective in continuous sc. insulin infusion as in multiple daily injections for patients with Type 2 diabetes. Diabetes (2001) 50(2):A128.
   Google Scholar
• LINDHOLM A, ANDERSEN HF, HYLLEBERG B, GALL M: A review of the safety profile of insulin aspart. Diabetologia (2000) 43\(Suppl. 1):A199.
   Google Scholar
• HELLER S, COLAGIURI S, VAALER S et al.: Reduced hypoglycemia with insulin aspart: A double-blind, randomised, crossover trial in Type 1 diabetic patients. Diabetes (2001) 50(2):A137. Abstract.
   Google Scholar
• FANELLI C, PARAMORE D, HERSHEY T etal.: Impact of nocturnal hypoglycemia on hypoglycemic cognitive dysfunction in Type 1 diabetes. Diabetes (1998) 47(12):1920–1927.
   Google Scholar
• HEPBURN D, PATRICK A, EADINGTON D, EWING D, FRIER B: Unawareness of hypoglycaemia in insulin-treated diabetic patients: prevalence and relationship to autonomic neuropathy. Diabet. Med. (1990) 7(8):711–717.
   PubMed Web of Science ®Google Scholar
• FRIER B, EWING E LINDHOLM A, HYLLEBERG B, KANC K: Symptomatic and counter-regulatory hormonal responses to acute hypoglycaemia induced by insulin aspart and soluble human insulin in Type 1 diabetes. Diabet. Metab. Res. Rev (2000) 16:262-268. •Use of IAsp is not associated with reduction in hypoglycaemic awareness.
   Google Scholar
• MCCRIMMON R, FRIER B: Symptomatic and physiological responses to hypoglycaemia induced by human soluble insulin and the analogue lispro human insulin. Diabet. Med. (1997) 14:929–936.
   PubMed Web of Science ®Google Scholar
• TORLONE E, FANELLI C, RAMBOTTI A et al.: Pharmacokinetics, pharmacodynamics and glucose counter-regulation following sc. injection of the monomeric insulin analogue Lys (B28) Pro(B29) in IDDM. Diabetologia (1994) 37:713–720.
   Google Scholar
• MARQUES J,GEORGE E, PEACEY S et al.: Altered ventricular repolarization during hypoglycaemia in patients with diabetes. Diabet. Med. (1997) 14(8):648–654.
   Google Scholar
• COLLIER A, MATTHEWS D, YOUNG R, CLARKE B: Transient atrial fibrillation precipitated by hypoglycemia: two case reports. Pestgrad. Med. j. (1987) 63:895–897.
   PubMed Web of Science ®Google Scholar
• TATTERSALL R, GILL G: Unexplained death of Type 1 diabetic patients. Diabet. Med. (1991) 8:49–58.
   PubMed Web of Science ®Google Scholar
• HANICH R, LEVINE J, SPEAR J, MOORE E: Autonomic modulation of ventricular arrhythmia in caesium chloride-induced long QT syndrome. Circulation (1988) 77:1149–1161.
   PubMed Web of Science ®Google Scholar
• JACKMAN W, FRIDAY K, ANDERSON J, ALIOT E, CLARK M, LAZZARRA R: The long QT syndromes: a critical review, new clinical observations and a unifying hypothesis. Frog. Cardiovasc. Dis. (1988) 31:115–172.
   PubMed Web of Science ®Google Scholar
• HARRIS N, ROBINSON R, IRELAND R, HELLER S: Phase I comparison with HI of effect on ventricular repolarisation during hypoglycaemia. Diabetes (1999) 48\(Suppl. 1):A114. Abstract 0490.
   Google Scholar
• LINDHOLM A, JACOBSEN LV: Clinical pharmacokinetics and pharmacodynamics of insulin aspart. Clin. Pharmacokinet. (2001) 40(9):641–659.
   PubMed Web of Science ®Google Scholar