Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea

References

• Weyer C, Bogardus C, Mott DM, et al. The natural history of insulin secretory dysfunction and insulin resistance in the pathogenesis of type 2 diabetes mellitus. J Clin Invest 1999;104:787-94
   PubMed Web of Science ®Google Scholar
• 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 1993;329:977-86
   PubMed Web of Science ®Google Scholar
• Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643-53
   PubMed Web of Science ®Google Scholar
• UKPDS 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;352:837-53
   PubMed Web of Science ®Google Scholar
• Ohkubo Y, Kishikawa H, Araki E, 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 Res Clin Pract 1995;28:103-17
   PubMed Web of Science ®Google Scholar
• Wake N, Hisashige A, Katayama T, et al. Cost-effectiveness of intensive insulin therapy for type 2 diabetes: a 10-year follow-up of the Kumamoto study. Diabetes Res Clin Pract 2000;48:201-10
   PubMed Web of Science ®Google Scholar
• Shichiri M, Kishikawa H, Ohkubo Y, et al. Long-term results of the Kumamoto Study on optimal diabetes control in type 2 diabetic patients. Diabetes Care 2000;23 (Suppl 2):B21-B29. UK Pros
   PubMed Web of Science ®Google Scholar
• The ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560-72
   PubMed Web of Science ®Google Scholar
• Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577-89
   PubMed Web of Science ®Google Scholar
• The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59
   PubMed Web of Science ®Google Scholar
• Koro CM, Bowlin SJ, Bourgeois N, et al. Glycemic control from 1988 to 2000 among U.S. adults diagnosed with type 2 diabetes. Diabetes Care 2004;27:17-20
   Google Scholar
• Harris MI, Eastman RC, Cowie CC, et al. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care 1999;22:403-8
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Position statement. Standards of Medical Care in Diabetes—2008. Diabetes Care 2008;31 (Suppl 1):S12-54
   PubMed Web of Science ®Google Scholar
• Kvapil M, Mikolajczyk-Swtko A, Ostergaard A, et al. Biphasic insulin aspart 30 combined with metformin provides better glycemic control in poorly type 2 diabetic patients. Diabetes 2002;51 (Suppl 2):Abstract 104
   Web of Science ®Google Scholar
• Kolterman OG, Buse JB, Finesman MS, et al. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab 2003;88:3082-9
   PubMed Web of Science ®Google Scholar
• Goke R, Fehmann HC, Linn T, et al. Exendin-4 is a high potency agonist and truncated exedin (9-39) amide an antagonist at the glucagon like peptide 1 (7-36) amide receptor of insulin-secreting beta cells. J Biol Chem 1993;268:19650-5
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Position Statement. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 2008;31:S55-60
   PubMed Web of Science ®Google Scholar
• World Medical Association. Declaration of Helsinki (2002) Ethical Principles for Medical Research Involving Human Subjects. 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. Last amended with Note of Clarification on Paragraph 29 by the WMA General Assembly, Washington
   Google Scholar
• International Conference on Harmonisation. ICH Harmonised Tripartite Guideline. Good Clinical Practice. 01-May-1996
   Google Scholar
• Nauck M, Duran S, Kim D, et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia 2007;50:259-67
   PubMed Web of Science ®Google Scholar
• Kendell DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005;28:1083-91
   PubMed Web of Science ®Google Scholar
• Raskin R, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes; a comparison of biphasic and basal insulin analogs. Diabetes Care 2005;28:260-5
   PubMed Web of Science ®Google Scholar
• Oyer DS, Shepherd MD, Coulter FC, et al. Efficacy and safety of dietary counseling coupled with initiation of biphasic insulin aspart 70/30 in type 2 diabetes patients - the INITIATE plus study. Diabetes 2007;56 (Suppl 1):A552(2180-po)
   Web of Science ®Google Scholar
• Riddle MC, Rosenstock J, Gerich JE, et al. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy in type 2 diabetic patients. Diabetes Care 2003;26:3080-6
   PubMed Web of Science ®Google Scholar
• Garber AJ, 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 Metab 2006;8:58-66
   PubMed Web of Science ®Google Scholar
• 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-naïve people with type 2 diabetes. Diabetes Care 2006;29:1269-74
   PubMed Web of Science ®Google Scholar
• Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006;49:442-51
   PubMed Web of Science ®Google Scholar
• Kahn SE, Steven CB, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427-43
   PubMed Web of Science ®Google Scholar
• Lund SS, Tarnow L, Pedersen OB, et al. REFORM Study: effect of BIAsp30 (NovoLog Mix 70/30) in combination with oral hypoglycaemic agents (OHA) on glycaemic control in non-obese patients with type 2 diabetes (T2DM). Diabetes 2005;54 (Suppl 1):A126
   Web of Science ®Google Scholar
• Bastyr EJ III , Stuart CA, Brodows RG, et al. Therapy focused on lowering postprandial glucose, not fasting glucose, may be superior for lowering HbA1c. IOEZ Study Group. Diabetes Care 2000;23:1236-41
   PubMed Web of Science ®Google Scholar
• de Veciana M, Major CA, Morgan MA, et al. Postprandial versus preprandial blood glucose monitoring in women with gestational diabetes mellitus requiring insulin therapy. N Engl J Med 1995;333:1237-41
   PubMed Web of Science ®Google Scholar
• 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 HbA1c. Diabetes Care 2003;26:881-5
   PubMed Web of Science ®Google Scholar
• Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005;28:260-5
   PubMed Web of Science ®Google Scholar
• Goke R, Fehmann HC, Linn T, et al. Exendin-4 is a high potency agonist and truncated exedin (9-39) amide an antagonist at the glucagon like peptide 1 (7-36) amide receptor of insulin-secreting beta cells. J Biol Chem 1993;268:19650-5
   PubMed Web of Science ®Google Scholar
• Flint A, Raben A, Astrup A, et al. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin. Invest 1998;101:515-520
   PubMed Web of Science ®Google Scholar
• Byetta package insert. Amylin Pharmaceuticals, Inc., San Diego, CA; 2007 February
   Google Scholar
• Vilsbøll T, Zdravkovic M, Le-Thi T, et al. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care 2007;30:1608-10
   PubMed Web of Science ®Google Scholar
• Davis SN, Johns D, Maggs D, et al. Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care 2007;30:2767-72
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Fonseca V. Missing the point: substituting exenatide for nonoptimized insulin: going from bad to worse. Diabetes Care 2007;30:2972-3
   PubMed Web of Science ®Google Scholar
• B O. Boehm, P. D. Home, C. Behrend, et al. Diabetic Med. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients Diabetic Med 2002;19:393-9
   Google Scholar
• Davidson J, Christiansen JS, Brown P, et al. Biphasic insulin aspart has a lower risk of hypoglycemia than biphasic human insulin without compromising glycemic control: a meta-analysis of randomized controlled trials. Diabetes 2008;57 (Suppl. 1):A171
   Web of Science ®Google Scholar
• Drucker DJ, Buse JB, Taylor K, et al. for the DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2006;372: 1240-50. Published Online September 8, 2008. doi:10.1016/S0140-6736(08) 61206-4
   Web of Science ®Google Scholar
• Madsbad S, Schmitz O, Ranstam J, et al. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care 2004;27:1335-42
   PubMed Web of Science ®Google Scholar
• Nauck MA, Hompesch M, Filipczak R, et al. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycemic control and lowers body weight in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes 2006;114:417-23
   PubMed Web of Science ®Google Scholar