Biphasic insulin aspart 30: Literature review of adverse events associated with treatment

Clinical Therapeutics

Volumn 27, Issue SUPPL. 2, 2005, Pages

  Davidson, Jaime ^a   Vexiau, Patrick ^b   Cucinotta, Domenico ^c   Vaz, Julius ^d   Kawamori, Ryuzo ^e  

^a Endocrine and Diabetes Associates of Texas   (United States)

^b SAINT LOUIS HOSPITAL   (France)

^c UNIVERSITY OF MESSINA   (Italy)

^d Novo Nordisk Pharma Singapore Pte Ltd   (Singapore)

^e JUNTENDO UNIVERSITY   (Japan)

Author keywords

biphasic insulin aspart; glycemic control; premixes; safety

Indexed keywords

BIPHASIC INSULIN; GLIBENCLAMIDE PLUS METFORMIN; HEMOGLOBIN A1C; INSULIN ANTIBODY; INSULIN ASPART; INSULIN GLARGINE; INSULIN LISPRO; ISOPHANE INSULIN; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; ANTIDIABETIC AGENT; DRUG DERIVATIVE; INSULIN; INSULIN, ASP(B28)-;

ACCIDENTAL INJURY; ANTIBODY BLOOD LEVEL; ARTICLE; BLOOD GLUCOSE MONITORING; CARDIOTOXICITY; CLINICAL TRIAL; CROSS REACTION; DISEASE ASSOCIATION; DISEASE DURATION; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; EVALUATION; FLU LIKE SYNDROME; HEMOGLOBIN DETERMINATION; HUMAN; HYPOGLYCEMIA; INFLUENZA; INFORMATION RETRIEVAL; INJECTION SITE CONTUSION; INSULIN DEPENDENT DIABETES MELLITUS; MEDICAL DOCUMENTATION; MEDICAL LITERATURE; MEDLINE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; POSTPRANDIAL STATE; PUBLICATION; RADIOIMMUNOASSAY; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; WEIGHT CHANGE; WEIGHT GAIN; ADULT; AGED; BLOOD; CHEMICALLY INDUCED DISORDER; CONTROLLED CLINICAL TRIAL; DIABETES MELLITUS; DRUG EFFECT; FEMALE; IMMUNOLOGY; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL; REVIEW;

ADULT; AGED; CLINICAL TRIALS; CROSS REACTIONS; DIABETES COMPLICATIONS; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; FEMALE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS; WEIGHT GAIN;

EID: 33644963379     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2005.11.022     Document Type: Article

References (50)

1. Small M., MacRury S., Boal A., et al. Comparison of conventional twice daily subcutaneous insulin administration and a multiple injection regimen (using the NovoPen) in insulin-dependent diabetes mellitus. Diabetes Res 8 (1988) 85-89
2. Yki-Jarvinen H., Kauppila M., Kujansuu E., et al. Comparison of insulin regimens in patients with non-insulin-dependent diabetes mellitus. N Engl J Med 327 (1992) 1426-1433
3. European Diabetes Policy Group. A desktop guide to type 2 diabetes mellitus. Diabet Med 16 (1999) 716-730
4. Lee W.L., and Zinman B. From insulin to insulin analogues: Progress in the treatment of type 1 diabetes. Diabetes Rev 6 (1998) 73-88
5. Davis T., and Edelman S.V. Insulin therapy in type 2 diabetes. Med Clin North Am 88 (2004) 865-895
6. Turner H.E., and Matthews D.R. The use of fixed-mixture insulins in clinical practice. Eur J Clin Pharmacol 56 (2000) 19-25
7. Ahmed A.B.E., Badgandi M., and Home P.D. Interval between insulin injection and meal in relation to glycated hemoglobin. Pract Diabet Int 18 (2001) 51-56
8. Heinemann L. Do insulin-treated diabetic patients use an injection-meal-interval in daily life?. Diabet Med. 12 (1995) 449-450
9. [published correction appears in Diabet Med. 2002;19:797]. Boehm B., Home P.D., Behrend C., et al. 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 19 (2002) 393-399
10. Jacobsen L.V., Sogaard B., and Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmcicol 56 (2000) 399-403
11. Weyer C., Heise T., and Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic pro perties of a rapid-acting insulin analogue in stable mixture. Diabetes Care 20 (1997) 1612-1614
12. Brange J., and Volund A. Insulin analogues with improved pharmacokinetic profiles. Adv Drug Deliv Rev 35 (1999) 307-335
13. Heinemann L., Kapitza C., Starke A.A., and Heise T. Time-action profile of the insulin analogue B28Asp. Diabet Med 13 (1996) 683-684
14. Volund A., Brange J., Drejer K., et al. In vitro and in vivo potency of insulin analogues designed for clinical use. Diabet Med 8 (1991) 839-847
15. Kang S., Owens D.R., Vora J.P., and Brange J. Comparison of insulin analogue B9AspB27Glu and soluble human insulin in insulin-treated diabetes. Lancet 335 (1990) 303-306
16. Lindholm A., McEwen J., and Riis A.P. Improved postprandial glycemic control with insulin aspart. A ran domized double-blind cross-over trial in type 1 diabetes. Diabetes Care 22 (1999) 801-805
17. Home P.D., Lindholm A., Hylleberg B., Round P., and UK Insulin Aspart Study Group. Improved glycemic control with insulin aspart: A multicenter randomized double-blind crossover trial in type 1 diabetic patients. Diabetes Care 21 (1998) 1904-1909
18. Rosenfalck A.M., Thorsby P., Kjems L., et al. Improved postprandial glycaemic control with insulin aspart in type 2 diabetic patients treated with insulin. Acta Diabetol 37 (2000) 41-46
19. Hermansen K., Colombo M., Storgaard H., et al. Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients withtype 2 diabetes. Diabetes Care 25 (2002) 883-888
20. McSorley P.T., Bell P.M., Jacobsen L.V., et al. Twice-daily biphasic insulin aspart 30 versus biphasic human in sulin 30: A double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther 24 (2002) 530-539
21. 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. N Engl J Med 329 (1993) 977-986
22. [published correction appears in Lancet. 1999; 354:602]. UK Prospective Diabetes Study (UKPDS) Group. Intensive bloodglucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352 (1998) 837-853
23. [published correction appears in Lancet. 1998;352:1557]. UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 352 (1998) 854-865
24. Stratton I.M., Adler A.I., Neil H.A., et al. Association ofglycaemiawith macrovascular and microvascular compli cations of type 2 diabetes (UKPDS 35): Prospective observational study. Br Med J. 321 (2000) 405-412
25. The Diabetes Control and Complications Trial Research Group. The absence of a glycemic threshold for the development of long-term complications: The perspective of the Diabetes Control and Complications Trial. Diabetes 45 (1996) 1289-1298
26. Hanefeld M., Fischer S., Julius U., et al., Diabetes Intervention Study. Risk factors for myocardial infarction and death in newly detected NIDDM: The Diabetes Intervention Study, 11-year follow-up. Diabetologia 39 (1996) 1577-1583
27. Haffner S.M. The importance of hyperglycemia in the nonfasting state to the development of cardiovascular disease. Endocr Rev 19 (1998) 583-592
28. Tominaga M., Eguchi H., Manaka H., et al., Funagata Diabetes Study. Impaired glucose tolerance is a risk factor for cardiovascular disease, but not impaired fasting glucose. Diabetes Care 22 (1999) 920-924
29. The Diabetes Epidemiology: Collaborative analysis Of Diagnostic criteria in Europe (DECODE) Study Group and the European Diabetes Epidemiology Group. Glucose tolerance and mortality: Comparison of WHO and American Diabetes Association diagnostic criteria. Lancet 354 (1999) 617-621
30. Esposito K., Giugliano D., Nappo F., Marfella R., and Campanian Postprandial Hyperglycemia Study Group. Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus. Circulation 110 (2004) 214-219
31. Ceriello A. The emerging role of post-prandial hyperglycaemic spikes in the pathogenesis of diabetic com plications. Diabet Med 15 (1998) 188-193
32. Del Prato S. Post-prandial hyperglycaemia-the necessity for better control. Int J Clin Pract Suppl. 112 (2000) 3-8
33. Hansen B.F., Danielsen G.M., Drejer K., et al. Sustained signalling from the insulin receptor after stimulation with insulin analogues exhibiting increased mitogenic potency. Biochem J. 315 (1996) 271-279
34. Kurtzhals P., Schaffer L., Sorensen A., et al. Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogues designed for clinical use. Diabetes 49 (2000) 999-1005
35. Heller S., Kurtzhals P., Verge D., and Lindholm A. Insulin aspart: Promising early results borne out in clinical practice. Expert Opin Pharmacother 3 (2002) 183-195
36. Hermansen K., Vaaler S., Madsbad S., et al. Postprandial glycemic control with biphasic insulin aspart in patients with type 1 diabetes. Metabolism 51 (2002) 896-900
37. Niskanen L., Jensen L.E., Rastam J., et al. Randomized, multinational, openlabel, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devicesin adult patients with type 2 diabetes mellitus. Clin Ther 26 (2004) 531-540
38. Kilo C., Mezitis N., Jain R., et al. Starting patients with type 2 diabetes on insulin therapy using once daily injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination with metformin. J Diabetes Complications 17 (2003) 307-313
39. Christiansen J.S., Vaz J.A., Metelko Z., et al. Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk ofhypoglycaemia, in patients with type 2 diabetes. Diabetes Obes Metab 5 (2003) 446-454
40. Abstract. Kvapil M., Mikolajczyk-Swatko A., Ostergaard A.H., and Shestakova M. Biphasic insulin aspart 30 combined with metformin provides better glycaemic control in poorly controlled type 2 diabetic patients. Diabetologia 45 Suppl 2 (2002) A18
41. Abstract. McNally P., Fitch M., and Nelson G. Patients with type 2 diabetes mellitus have lower rates of nocturnal hypoglycaemia on biphasic insulin aspart (BIAsp 30) than on biphasic humaninsulin-30 (BHI 30). Diabetologia 47 Suppl 1 (2004) A327
42. Raz I., Mouritzen U., Vaz J., et al. Addition of biphasic insulin aspart 30 to rosiglitazone in type 2 diabetes mellitus that is poorly controlled with glibenclamide monotherapy. Clin Ther. 25 (2003) 3109-3123
43. Abstract. Raz I., Stranks S., Filipczak R., et al. In inadequately controlled patients with type 2 diabetes, biphasic insulin aspart 30 combined with pioglitazone provides better glycaemic controlthan biphasic insulin aspart 30 monotherapy or pioglitazone/sulphonylurea combination. Diabetologia 46 Suppl 2 (2003) A8
44. Abstract. Raz I., Weinstein J., Hershkovitz T.A., et al. Add-on of insulin or a second oral agent? Evaluation of premixed insulin aspart in combination with repaglinide, glibenclamide, metformin androsiglitazone. Diabetologia 45 Suppl 2 (2002) A263
45. Abstract. Iwamoto Y., and Akanuma Y. Comparison of biphasic insulin aspart 30 and biphasic human insulin after 48 weeks of treatment in type 2 diabetes: Phase III clinical trial. Diabetologia 46 Suppl 2 (2002) A270
46. Abstract. Jain R., Wahl T., Wahlen J., et al. Patients with type 2 diabetes can achieve Al C targets with once-daily biphasic insulin aspart 70/30 (NovoLog Mix® 70/30) before supper. Diabetes 53 Suppl 2 (2004) A130
47. Warren M.L., Conway M.J., Klaff L.J., et al. Postprandial versus preprandial dosing of biphasic insulin aspart in elderly type 2 diabetes patients. Diabetes Res Clin Pract 66 (2004) 23-29
48. Boehm B.O., Vaz J.A., Brondsted L., and Home P.D. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur J Intern Med 15 (2004) 496-502
49. Raskin P., Allen E., Hollander P., et al. Initiating insulin therapy in type 2 diabetes: A comparison of biphasic and basal insulin analogues. Diabetes Care 28 (2005) 260-265
50. Lindholm A., Jensen L.B., Home P.D., et al. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care 25 (2002) 876-882