The Use of Premixed Insulin Analogues in the Treatment of Patients with Type 2 Diabetes Mellitus: Advantages and Limitations

Insulin

Volumn 2, Issue 2, 2007, Pages 68-79

  Rizvi, Ali A ^a   Ligthelm, Robert J ^b  

^a UNIVERSITY OF SOUTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b EHM Clinic   (Netherlands)

Author keywords

type 2 diabetes mellitus, basal bolus therapy, premixed insulin, biphasic insulin, insulin analogues.

Indexed keywords

BIPHASIC INSULIN; EXENDIN 4; GLIBENCLAMIDE; GLIMEPIRIDE; HUMALOG MIX; HUMAN INSULIN; INSULIN; INSULIN ASPART; INSULIN DERIVATIVE; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; ISOPHANE INSULIN; METFORMIN; ORAL ANTIDIABETIC AGENT; PRAMLINTIDE; SULFONYLUREA; UNCLASSIFIED DRUG;

ADD ON THERAPY; ARTICLE; CARDIOVASCULAR RISK; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DATA EXTRACTION; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG MIXTURE; DRUG SUBSTITUTION; DRUG TARGETING; DRUG USE; DRUG WITHDRAWAL; EARLY INTERVENTION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPERGLYCEMIA; INFORMATION RETRIEVAL; INSULIN HYPOGLYCEMIA; INSULIN RELEASE; INSULIN TREATMENT; MEDLINE; MONOTHERAPY; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT ATTITUDE; PATIENT CARE; SIDE EFFECT; WEIGHT GAIN;

EID: 34548307291     PISSN: 15570843     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1557-0843(07)80018-2     Document Type: Article

References (63)

1. Mann J. Stemming the tide of diabetes mellitus. Lancet. 356 (2000) 1454-1455
2. Zimmet P., Alberti K.G., and Shaw J. Global and societal implications of the diabetes epidemic. Nature. 414 (2001) 782-787
3. Grant R.W., Cagliero E., Murphy-Sheehy P., et al. Comparison of hyperglycemia, hypertension, and hypercholesterolemia management in patients with type 2 diabetes. Am J Med. 112 (2002) 603-609
4. Saaddine J.B., Engelgau M.M., Beckles G.L., et al. A diabetes report card for the United States: Quality of care in the 1990s. Ann Intern Med. 136 (2002) 565-574
5. 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) [published correction appears in Lancet. 1999;354:602]. Lancet. 352 (1998) 837-853
6. Nathan D.M. Clinical practice. Initial management of glycemia in type 2 diabetes mellitus. N EngI J Med. 347 (2002) 1342-1349
7. Riddle M.C. Timely initiation of basal insulin. Am J Med. 116 Suppl 3A (2004) 3S-9S
8. Phillips L.S., Branch W.T., Cook C.B., et al. Clinical inertia. Ann Intern Med. 135 (2001) 825-834
9. Ellrodt A.G., Conner L., Riedinger M., and Weingarten S. Measuring and improving physician compliance with clinical practice guidelines. A controlled interventional trial. Ann Intern Med. 122 (1995) 277-282
10. Eakin E.G., and Glasgow R.E. Physician's role in diabetes selfmanagement: Helping patients to help themselves. Endocrinologist. 6 (1996) 186-195
11. Nyman M.A., Murphy M.E., Schryver P.G., et al. Improving performance in diabetes care: A multicomponent intervention. Eff Clin Proct. 3 (2000) 205-212
12. Leahy J.L. What is the role for insulin therapy in type 2 diabetes?. Curr Opin Endocr Diabetes. 10 (2003) 99-103
13. Chan J.L., and Abrahamson M.J. Pharmacological management of type 2 diabetes mellitus: Rationale for the rational use of insulin. Mayo Clin Proc. 78 (2003) 459-467
14. Monnier L., Lapinski H., and 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(1 c). Diabetes Care. 26 (2003) 881-885
15. McDonald K. Insulin therapy today. Focusing on the basal-bolus balance. Adv Nurse Proct. 11 (2003) 40-45
16. Herman W.H., Dasbach E.J., Sanger T.J., et al. Assessing the impact of intensive insulin therapy on the health care system. Diabetes Rey. 2 (1994) 384-388
17. Hermansen K., Davies M., Derezinski T., et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 29 (2006) 1269-1274
18. Riddle M.C., Rosenstock J., Gerich J., and Insulin Glargine 4002 Study Investigators. The treat-to-target trial: Randomized addition of glargine or human NPH insulin to oral therapy of type2 diabetic patients. Diabetes Care. 26 (2003) 3080-3086
19. Brownlee M., and Hirsch I.B. Glycemic variability: A hemoglobin Al cindependent risk factor for diabetic complications. JAMA. 295 (2006) 1707-1708
20. Ceriello A. Postprandial hyperglycemia and diabetes complications: Is it time to treat?. Diabetes 54 (2005) 1-7
21. Del Prato S. Tackling hyperglycemia: A more comprehensive approach. Endocr Proct. 12 Suppl 1 (2006) 63-66
22. Monnier L., and Colette C. Addition of rapid-acting insulin to basal insulin therapy in type 2 diabetes: Indications and modalities. Diabetes Metob. 32 (2006) 7-13
23. Koivisto V.A., Tuominen J.A., and Ebeling P. Lispro mix25 insulin as premeal therapy in type 2 diabetic patients. Diabetes Care. 22 (1999) 459-462
24. Weyer C., Heise T., and Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapidacting insulin analog in stable mixture. Diabetes Care. 20 (1997) 1612-1614
25. Jacobsen L.V., Sogaard B., and Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamineretarded insulin aspart. Eur J Clin Phormocol. 56 (2000) 399-403
26. McSorley P.T., Bell P.M., Jacobsen L.V., et al. Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: A doubleblind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 24 (2002) 530-539
27. Kapitza C., Rave K., Ostrowski K., et al. Reduced postprandial glycaemic excursion with biphasic insulin aspart 30 injected immediately before a meal. Diabet Med. 21 (2004) 500-501
28. 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 Proct. 66 (2004) 23-29
29. Sridhar G.R. Two regimens of twice-daily premix insulin analogue: An observational study. Diabetes Res Clin Proct. 71 (2006) 105-107
30. 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
31. Boehm B.O., 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 [publishedcorrection appears in Diabet Med. 2002;19:797]. Diabet Med. 19 (2002) 393-399
32. Boehm B.O., Vaz J.A., Brondstedt 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
33. McNally P., Fitch M., and Nelson G. Patients with type 2 diabetes mellitus have lower rates of nocturnal hypoglycemia on biphasic insulin aspart (BIAsp 30) than on biphasic human insulin-30 (BH130): Data from the REACH study. Diabetologia. 47 Suppl 1 (2004) A327
34. Luzio S., Dunseath G., Peter R., et al. Comparison of the pharmacokinetics and pharmacodynamics of biphasic insulin aspart and insulin glargine in people with type 2 diabetes. Diabetologia. 49 (2006) 1163-1168
35. Raskin P., Allen E., Hollander P., et al., INITIATE Study Group. Initiating insulin therapy in type 2 diabetes: A comparison of biphasic and basal insulin analogs. Diabetes Care. 28 (2005) 260-265
36. Kann P.H., Wascher T., Zackova V., et al. Starting insulin therapy in type 2 diabetes: Twice-daily biphasic insulin aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes 114 (2006) 527-532
37. Malone J.K., Kerr L.F., Campaigne B.N., et al., Lispro MixtureGlargine Study Group. Combined therapy with insulin lispro mix 75/25 plus metformin or insulin glargine plus metformin: A 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy [published correction appears in Clin Ther. 2005;27:1112]. Clin Ther. 26 (2004) 2034-2044
38. Suwanwalaikorn S. Optimising glycaemic control with BIAsp30 (once or twice daily) in combination with oral antidiabetic agents in type 2 diabetes. Diabetologia 48 Suppl 1 (2005) A308
39. Lund S.S., Tarnow L., Pedersen O.B., et al. Effect of BlAsp30 (NovoLog Mix 70/30) in combination with oral hypoglycaemic agents (OHA) on glycaemic control in non-obese patients with type-2 diabetes (T2DM). Diabetes 56 Suppl 1 (2005) A126
40. 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
41. Garber A.J., Wahlen J., Wahl T., et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study). Diabetes Obes Metob. 8 (2006) 58-66
42. Ligthelm R.J. Number of daily insulin injections required does not affect patient well being. Diabetes 54 Suppl 1 (2005) A501
43. Janka H.U., Plewe G., Riddle M.C., et al. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 28 (2005) 254-259
44. Kabadi U.M., and Kabadi M. Comparative efficacy of glimepiride and/or metformin with insulin in type 2 diabetes. Diabetes Res Clin Proct 72 (2006) 265-270
45. Raskin P., Braceras R., Schwartz S., et al. Over 75% of patients with type 2 diabetes reached target Al c by adding biphasic insulin aspart 70/30 to optimized metformin and pioglitazonetreatment. Diabetes 55 Suppl 1 (2006) A131
46. Liebl A., Prager R., Kaiser M., et al., PREFER study group. Biphasic insulin aspart 30 (BIAsp30), insulin detemir (IDet) and insulin aspart (IAsp) allow patients with type 2 diabetes to reach AIC target: ThePREFER Study. Diabetes 55 Suppl 1 (2006) A123
47. Tirgoviste C.I., Strachinariu R., Farcasiu E., et al. Humalog Mix 25 in patients with type 2 diabetes which do not achieve acceptable glycemic control with oral agents: Results from a phase III, randomized, parallel study. Rom J Intern Med 41 (2003) 153-162
48. 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 Metob 5 (2003) 446-454
49. Abrahamian H., Ludvik B., Schernthaner G., et al. Improvement of glucose tolerance in type 2 diabetic patients: Traditional vs. modern insulin regimens (results from the Austrian Biaspart Study). Horm Metob Res 37 (2005) 684-689
50. Ristic S., and Bates P.C. Effects of rapid-acting insulin analogs on overall glycemic control in type 1 and type 2 diabetes mellitus. Diabetes Technol Ther 5 (2003) 57-66
51. Bott U., Ebrahim S., Hirschberger S., and Skovlund S.E. Effect of the rapid-acting insulin analogue aspart on quality of life and treatment satisfaction in patients with type 1 diabetes. Diabet Med 20 (2003) 626-634
52. [package insert]. NovoLog Mix 70/30 (2005), Novo Nordisk Inc, Princeton, NJ
53. [package insert]. Humalog Mix 75/25 (2004), Eli Lilly & Company, Indianapolis, IN
54. [package insert]. Humalog Mix 50/50 (2005), Eli Lilly & Company, Indianapolis, IN
55. Korytkowski M., Bell D., Jacobsen C., Suwannasari R./, and FlexPen Study Team. A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled,disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clin Ther 25 (2003) 2836-2848
56. Mooradian A.D., Bernbaum M., and Albert S.G. Narrative review: A rational approach to starting insulin therapy. Ann Intern Med 145 (2006) 125-134
57. DeFronzo R.A. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med 131 (1999) 281-303
58. Edelman S.V., and Morello C.M. Strategies for insulin therapy in type 2 diabetes. South Med J 98 (2005) 363-371
59. Chehade J.M., and Mooradian A.D. A rational approach to drug therapy of type 2 diabetes mellitus. Drugs 60 (2000) 95-113
60. Davidson J., Vexiau P., Cucinotta D., et al. Biphasic insulin aspart 30: Literature review of adverse events associated with treatment. Clin Ther 27 Suppl B (2005) S75-S88
61. Su C.C., Chen H.S., and Lin H.D. Glycemic control with different premixed insulin in Taiwanese people with type two diabetes mellitus. J Chin Med Assoc 66 (2003) 155-159
62. Ligthelm R.J., Mouritzen U., Lynggaard H., et al. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections. Exp Clin Endocrinol Diabetes 114 (2006) 511-519
63. Carroll M.F., and Schade D.S. The dawn phenomenon revisited: Implications for diabetes therapy. Endocr Proct 11 (2005) 55-64