Review an update on exenatide, a novel therapeutic option for patients with type 2 diabetes

Drugs of Today

Volumn 47, Issue 11, 2011, Pages 839-856

  Crasto, W ^a,b   Khunti, K ^a,b   Davies, Melanie J ^a,b  

^a LEICESTER ROYAL INFIRMARY   (United Kingdom)

^b UNIVERSITY OF LEICESTER   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EXENDIN 4; HEMOGLOBIN A1C; INSULIN ASPART; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; SITAGLIPTIN; SULFONYLUREA; WARFARIN; ANTIDIABETIC AGENT; INCRETIN; PEPTIDE; VENOM;

ACUTE HEMORRHAGIC PANCREATITIS; ACUTE PANCREATITIS; ANTIBODY PRODUCTION; BLEEDING; DIARRHEA; DRUG EFFECT; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART RATE; HEMORRHAGIC PANCREATITIS; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INJECTION SITE REACTION; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; QUALITY OF LIFE; RESPIRATORY TRACT INFECTION; REVIEW; SIDE EFFECT; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; ANIMAL; CLINICAL TRIAL (TOPIC); DRUG INTERACTION; METABOLISM;

ANIMALS; CLINICAL TRIALS AS TOPIC; DIABETES MELLITUS, TYPE 2; DRUG INTERACTIONS; HUMANS; HYPOGLYCEMIC AGENTS; INCRETINS; PEPTIDES; QUALITY OF LIFE; VENOMS;

EID: 83255191813     PISSN: 16993993     EISSN: 16994019     Source Type: Journal    
DOI: 10.1358/dot.2011.47.11.1688575     Document Type: Review

References (99)

1. Morrish, N.J., Wang, S.L., Stevens, L.K., Fuller, J.H., Keen, H. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia 2001, 44(Suppl. 2): S14-21. (Pubitemid 32844108)
2. Wild, S., Roglic, G., Green, A., Sicree, R., King, H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004, 27(5): 1047-53. (Pubitemid 38579764)
3. Nathan, D.M., Buse, J.B., Davidson, M.B., Heine, R.J., Holman, R.R., Sherwin, R., Zinman, B. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006, 29(8): 1963-72. (Pubitemid 44156663)
4. Hendry, J. FDA approves exenatide. DOC News 2005, 2(7): 1-6.
5. Weyer, C., Bogardus, C., Mott, D.M., Pratley, R.E. The natural history of insulin secretory dysfunction and insulin resistance in the pathogenesis of type 2 diabetes mellitus. J Clin Invest 1999, 104(6): 787-94. (Pubitemid 29536364)
6. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998, 352(9131): 854-65.
7. Curry, D.L., Bennett, L.L., Grodsky, G.M. Dynamics of insulin secretion by the perfused rat pancreas. Endocrinology 1968, 83(3): 572-84.
8. Perley, M.J., Kipnis, D.M. Plasma insulin responses to oral and intravenous glucose: studies in normal and diabetic sujbjects. J Clin Invest 1967, 46(12): 1954-62.
9. Gerich, J.E. Is reduced first-phase insulin release the earliest detectable abnormality in individuals destined to develop type 2 diabetes? Diabetes 2002, 51(Suppl. 1): S117-21. (Pubitemid 34761505)
10. Ludvik, B., Nolan, J.J., Roberts, A., Baloga, J., Joyce, M., Bell, J.M., Olefsky, J.M. Evidence for decreased splanchnic glucose uptake after oral glucose administration in non-insulin-dependent diabetes mellitus. J Clin Invest 1997, 100(9): 2354-61. (Pubitemid 27500160)
11. Brunzell, J.D., Robertson, R.P., Lerner, R.L., Hazzard, W.R., Ensinck, J.W., Bierman, E.L., Porte, D., Jr. Relationships between fasting plasma glucose levels and insulin secretion during intravenous glucose tolerance tests. J Clin Endocrinol Metab 1976, 42(2): 222-9.
12. Wajchenberg, B.L. Beta-cell failure in diabetes and preservation by clinical treatment. Endocr Rev 2007, 28(2): 187-218. (Pubitemid 46984834)
13. Creutzfeldt, W. The incretin concept today. Diabetologia 1979, 16(2): 75-85. (Pubitemid 9231263)
14. Elrick, H., Stimmler, L., Hlad, C.J., Jr., Arai, Y. Plasma Insulin Response to Oral and Intravenous Glucose Administration. J Clin Endocrinol Metab 1964, 24: 1076-82.
15. Nauck, M.A., Kleine, N., Orskov, C., Holst, J.J., Willms, B., Creutzfeldt, W. Normalization of fasting hyperglycaemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia 1993, 36(8): 741-4. (Pubitemid 23218642)
16. Buteau, J., Foisy, S., Joly, E., Prentki, M. Glucagon-like peptide 1 induces pancreatic beta-cell proliferation via transactivation of the epidermal growth factor receptor. Diabetes 2003, 52(1): 124-32. (Pubitemid 36042116)
17. Drucker, D.J. The biology of incretin hormones. Cell Metab 2006, 3(3): 153-65.
18. Drucker, D.J., Philippe, J., Mojsov, S., Chick, W.L., Habener, J.F. Glucagon-like peptide I stimulates insulin gene expression and increases cyclic AMP levels in a rat islet cell line. Proc Natl Acad Sci U S A 1987, 84(10): 3434-8. (Pubitemid 17085418)
19. Deane, A.M., Nguyen, N.Q., Stevens, J.E. et al. Endogenous glucagon-like peptide-1 slows gastric emptying in healthy subjects, attenuating postprandial glycemia. J Clin Endocrinol Metab 2010, 95(1): 215-21.
20. Holst, J.J. The physiology of glucagon-like peptide 1. Physiol Rev 2007, 87(4): 1409-39. (Pubitemid 350041474)
21. Zander, M., Madsbad, S., Madsen, J.L., Holst, J.J. Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and beta-cell function in type 2 diabetes: a parallel-group study. Lancet 2002, 359(9309): 824-30. (Pubitemid 34233752)
22. Farilla, L., Bulotta, A., Hirshberg, B. et al. Glucagon-like peptide 1 inhibits cell apoptosis and improves glucose responsiveness of freshly isolated human islets. Endocrinology 2003, 144(12): 5149-58. (Pubitemid 37476040)
23. Mentlein, R., Gallwitz, B., Schmidt, W.E. Dipeptidyl-peptidase IV hydrolyses gastric inhibitory polypeptide, glucagonlike peptide-1(7-36)amide, peptide histidine methionine and is responsible for their degradation in human serum. Eur J Biochem 1993, 214(3): 829-35. (Pubitemid 23188160)
24. Larsen, J., Hylleberg, B., Ng, K., Damsbo, P. Glucagon-like peptide-1 infusion must be maintained for 24 h/day to obtain acceptable glycemia in type 2 diabetic patients who are poorly controlled on sulphonylurea treatment. Diabetes Care 2001, 24(8): 1416-21. (Pubitemid 33716430)
25. Eng, J., Kleinman, W.A., Singh, L., Singh, G., Raufman, J.P. Isolation and characterization of exendin-4, an exendin-3 analogue, from Heloderma suspectum venom. Further evidence for an exendin receptor on dispersed acini from guinea pig pancreas. J Biol Chem 1992, 267(11): 7402-5.
26. Young, A.A., Gedulin, B.R., Bhavsar, S., Bodkin, N., Jodka, C., Hansen, B., Denaro, M. Glucose-lowering and insulin-sensitizing actions of exendin-4: studies in obese diabetic (ob/ob, db/db) mice, diabetic fatty Zucker rats, and diabetic rhesus monkeys (Macaca mulatta). Diabetes 1999, 48(5): 1026-34. (Pubitemid 29226349)
27. Parkes, D.G., Pittner, R., Jodka, C., Smith, P., Young, A. Insulinotropic actions of exendin-4 and glucagon-like peptide-1 in vivo and in vitro. Metabolism 2001, 50(5): 583-9. (Pubitemid 32433049)
28. Calara, F., Taylor, K., Han, J., Zabala, E., Carr, E.M., Wintle, M., Fineman, M. A randomized, open-label, crossover study examining the effect of injection site on bioavailability of exenatide (synthetic exendin-4). Clin Ther 2005, 27(2): 210-5. (Pubitemid 40462014)
29. Fineman, M., Flanagan, S., Taylor, K. et al. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet 2011, 50(1): 65-74.
30. Taylor, K., Kim, D., Nielsen, L.L., Aisporna, M., Baron, A.D., Fineman, M.S. Day-long subcutaneous infusion of exenatide lowers glycemia in patients with type 2 diabetes. Horm Metab Res 2005, 37(10): 627-32. (Pubitemid 41597574)
31. Kim, D., MacConell, L., Zhuang, D., Kothare, P.A., Trautmann, M., Fineman, M., Taylor, K. Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care 2007, 30(6): 1487-93. (Pubitemid 46871159)
32. Linnebjerg, H., Kothare, P.A., Park, S., Mace, K., Reddy, S., Mitchell, M., Lins, R. Effect of renal impairment on the pharmacokinetics of exenatide. Br J Clin Pharmacol 2007, 64(3): 317-27. (Pubitemid 47283860)
33. Kothare, P.A., Soon, D.K., Linnebjerg, H. et al. Effect of exenatide on the steady-state pharmacokinetics of digoxin. J Clin Pharmacol 2005, 45(9): 1032-7. (Pubitemid 41192362)
34. Linnebjerg, H., Kothare, P., Park, S., Mace, K., Mitchell, M. The effect of exenatide on lisinopril pharmacodynamics and pharmacokinetics in patients with hypertension. Int J Clin Pharmacol Ther 2009, 47(11): 651-8.
35. Kothare, P.A., Linnebjerg, H., Skrivanek, Z. et al. Exenatide effects on statin pharmacokinetics and lipid response. Int J Clin Pharmacol Ther 2007, 45(2): 114-20. (Pubitemid 46344143)
36. Soon, D., Kothare, P.A., Linnebjerg, H., Park, S., Yuen, E., Mace, K.F., Wise, S.D. Effect of exenatide on the pharmacokinetics and pharmacodynamics of warfarin in healthy Asian men. J Clin Pharmacol 2006, 46(10): 1179-87. (Pubitemid 44387418)
37. Li, Y., Hansotia, T., Yusta, B., Ris, F., Halban, P.A., Drucker, D.J. Glucagon-like peptide-1 receptor signaling modulates beta cell apoptosis. J Biol Chem 2003, 278(1): 471-8. (Pubitemid 36043598)
38. Tourrel, C., Bailbe, D., Meile, M.J., Kergoat, M., Portha, B. Glucagon-like peptide-1 and exendin-4 stimulate beta-cell neogenesis in streptozotocin-treated newborn rats resulting in persistently improved glucose homeostasis at adult age. Diabetes 2001, 50(7): 1562-70. (Pubitemid 33639596)
39. Xu, G., Stoffers, D.A., Habener, J.F., Bonner-Weir, S. Exendin-4 stimulates both beta-cell replication and neogenesis, resulting in increased beta-cell mass and improved glucose tolerance in diabetic rats. Diabetes 1999, 48(12): 2270-6. (Pubitemid 30395416)
40. Xu, G., Kaneto, H., Lopez-Avalos, M.D., Weir, G.C., Bonner-Weir, S. GLP-1/exendin-4 facilitates beta-cell neogenesis in rat and human pancreatic ducts. Diabetes Res Clin Pract 2006, 73(1): 107-10. (Pubitemid 43765553)
41. Chen, J., Couto, F.M., Minn, A.H., Shalev, A. Exenatide inhibits beta-cell apoptosis by decreasing thioredoxin-interacting protein. Biochem Biophys Res Commun 2006, 346(3): 1067-74.
42. Butler, P.C., Meier, J.J., Butler, A.E., Bhushan, A. The replication of beta cells in normal physiology, in disease and for therapy. Nat Clin Pract Endocrinol Metab 2007, 3(11): 758-68. (Pubitemid 47622601)
43. Bunck, M.C., Diamant, M., Corner, A. et al. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care 2009, 32(5): 762-8.
44. Gedulin, B.R., Nikoulina, S.E., Smith, P.A. et al. Exenatide (exendin-4) improves insulin sensitivity and {beta}-cell mass in insulin-resistant obese fa/fa Zucker rats independent of glycemia and body weight. Endocrinology 2005, 146(4): 2069-76. (Pubitemid 40396918)
45. Sloop, K.W., Willard, F.S., Brenner, M.B. et al. Novel small molecule glucagon-like peptide-1 receptor agonist stimulates insulin secretion in rodents and from human islets. Diabetes 2010, 59(12): 3099-107.
46. Poitout, V., Olson, L.K., Robertson, R.P. Insulin-secreting cell lines: classification, characteristics and potential applications. Diabetes Metab 1996, 22(1): 7-14.
47. Fehse, F., Trautmann, M., Holst, J.J. et al. Exenatide augments first- and second-phase insulin secretion in response to intravenous glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab 2005, 90(11): 5991-7. (Pubitemid 41606516)
48. Cervera, A., Wajcberg, E., Sriwijitkamol, A. et al. Mechanism of action of exenatide to reduce postprandial hyperglycemia in type 2 diabetes. Am J Physiol Endocrinol Metab 2008, 294(5): E846-52.
49. Kolterman, O.G., Buse, J.B., Fineman, M.S. 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(7): 3082-9. (Pubitemid 36877476)
50. DeFronzo, R.A., Okerson, T., Viswanathan, P., Guan, X., Holcombe, J.H., MacConell, L. Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study. Curr Med Res Opin 2008, 24(10): 2943-52.
51. Cersosimo, E., Gastaldelli, A., Cervera, A. et al. Effect of exenatide on splanchnic and peripheral glucose metabolism in type 2 diabetic subjects. J Clin Endocrinol Metab 2011, 96(6): 1763-70.
52. Linnebjerg, H., Kothare, P.A., Skrivanek, Z., de la Pena, A., Atkins, M., Ernest, C.S., Trautmann, M.E. Exenatide: effect of injection time on postprandial glucose in patients with Type 2 diabetes. Diabet Med 2006, 23(3): 240-5.
53. Meier, J.J., Gallwitz, B., Salmen, S., Goetze, O., Holst, J.J., Schmidt, W.E., Nauck, M.A. Normalization of glucose concentrations and deceleration of gastric emptying after solid meals during intravenous glucagon-like peptide 1 in patients with type 2 diabetes. J Clin Endocrinol Metab 2003, 88(6): 2719-25. (Pubitemid 36733545)
54. Toft-Nielsen, M.B., Madsbad, S., Holst, J.J. Continuous subcutaneous infusion of glucagon-like peptide 1 lowers plasma glucose and reduces appetite in type 2 diabetic patients. Diabetes Care 1999, 22(7): 1137-43. (Pubitemid 29293967)
55. Pannacciulli, N., Le, D.S., Salbe, A.D., Chen, K., Reiman, E.M., Tataranni, P.A., Krakoff, J. Postprandial glucagon-like peptide-1 (GLP-1) response is positively associated with changes in neuronal activity of brain areas implicated in satiety and food intake regulation in humans. Neuroimage 2007, 35(2): 511-7. (Pubitemid 46400565)
56. Goke, R., Larsen, P.J., Mikkelsen, J.D., Sheikh, S.P. Distribution of GLP-1 binding sites in the rat brain: evidence that exendin-4 is a ligand of brain GLP-1 binding sites. Eur J Neurosci 1995, 7(11): 2294-300.
57. Szayna, M., Doyle, M.E., Betkey, J.A., Holloway, H.W., Spencer, R.G., Greig, N.H., Egan, J.M. Exendin-4 decelerates food intake, weight gain, and fat deposition in Zucker rats. Endocrinology 2000, 141(6): 1936-41. (Pubitemid 32274340)
58. Buse, J.B., Henry, R.R., Han, J., Kim, D.D., Fineman, M.S., Baron, A.D. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004, 27(11): 2628-35. (Pubitemid 39441462)
59. DeFronzo, R.A., Ratner, R.E., Han, J., Kim, D.D., Fineman, M.S., Baron, A.D. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care 2005, 28(5): 1092-100. (Pubitemid 40616618)
60. Kendall, D.M., Riddle, M.C., Rosenstock, J., Zhuang, D., Kim, D.D., Fineman, M.S., Baron, A.D. 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(5): 1083-91. (Pubitemid 40616617)
61. Zinman, B., Hoogwerf, B.J., Duran Garcia, S. et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2007, 146(7): 477-85. (Pubitemid 351650556)
62. Blonde, L., Klein, E.J., Han, J. et al. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab 2006, 8(4): 436-47. (Pubitemid 44349236)
63. Klonoff, D.C., Buse, J.B., Nielsen, L.L. et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin 2008, 24(1): 275-86. (Pubitemid 351160260)
64. Barnett, A.H., Burger, J., Johns, D., Brodows, R., Kendall, D.M., Roberts, A., Trautmann, M.E. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clin Ther 2007, 29(11): 2333-48. (Pubitemid 350298125)
65. Davies, M.J., Donnelly, R., Barnett, A.H., Jones, S., Nicolay, C., Kilcoyne, A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab 2009, 11(12): 1153-62.
66. Heine, R.J., Van Gaal, L.F., Johns, D., Mihm, M.J., Widel, M.H., Brodows, R.G. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med 2005, 143(8): 559-69.
67. Nauck, M.A., 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(2): 259-67.
68. Bunck, M.C., Diamant, M., Eliasson, B. et al. Exenatide affects circulating cardiovascular risk biomarkers independently of changes in body composition. Diabetes Care 2010, 33(8): 1734-7.
69. Amylin Pharmaceuticals Inc. Byetta [package insert]. http://pi.lilly.com/ us/byetta-pi.pdf. Accessed August 17, 2011.
70. Buse, J.B., Bergenstal, R.M., Glass, L.C. et al. Use of twice-daily exenatide in basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med 2011, 154(2): 103-12.
71. Sheffield, C.A., Kane, M.P., Busch, R.S., Bakst, G., Abelseth, J.M., Hamilton, R.A. Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus. Endocr Pract 2008, 14(3): 285-92.
72. Yoon, N.M., Cavaghan, M.K., Brunelle, R.L., Roach, P. Exenatide added to insulin therapy: a retrospective review of clinical practice over two years in an academic endocrinology outpatient setting. Clin Ther 2009, 31(7): 1511-23.
73. Thong, K.Y., Jose, B., Sukumar, N. et al. Safety, efficacy and tolerability of exenatide in combination with insulin in the Association of British Clinical Diabetologists nationwide exenatide audit. Diabetes Obes Metab 2011, 13(8): 703-10.
74. Buse, J.B., Rosenstock, J., Sesti, G. et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009, 374(9683): 39-47.
75. Tracy, M.A., Ward, K.L., Firouzabadian, L., Wang, Y., Dong, N., Qian, R., Zhang, Y. Factors affecting the degradation rate of poly(lactide-co-glycolide) microspheres in vivo and in vitro. Biomaterials 1999, 20(11): 1057-62. (Pubitemid 29229474)
76. Drucker, D.J., Buse, J.B., Taylor, K., Kendall, D.M., Trautmann, M., Zhuang, D., Porter, L. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 2008, 372(9645): 1240-50.
77. Buse, J.B., Drucker, D.J., Taylor, K.L. et al. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care 2010, 33(6): 1255-61.
78. Taylor, K., Gurney, K., Han, J., Pencek, R., Walsh, B., Trautmann, M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord 2011, 11: 9.
79. Blevins, T., Pullman, J., Malloy, J. et al. DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. J Clin Endocrinol Metab 2011, 96(5): 1301-10.
80. Bergenstal, R.M., Wysham, C., Macconell, L. et al. Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Lancet 2010, 376(9739): 431-9.
81. Wysham, C., Bergenstal, R., Malloy, J., Yan, P., Walsh, B., Malone, J., Taylor, K. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabet Med 2011, 28(6): 705-14.
82. DURATION-4 study results: BYDUREON efficacy and tolerability profile extended to monotherapy treatment [news release]. Amylin Pharmaceuticals, Inc., June 15, 2010. Accessed November 8, 2011.
83. Diamant, M., Van Gaal, L., Stranks, S., Northrup, J., Cao, D., Taylor, K., Trautmann, M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet 2010, 375(9733): 2234-43.
84. DURATION-6 top-line study results announced [news release]. Amylin Pharmaceuticals, Inc., Eli Lilly and Company, Alkermes, Inc., March 3, 2011. Accessed November 8, 2011.
85. Dore, D.D., Bloomgren, G.L., Wenten, M. et al. A cohort study of acute pancreatitis in relation to exenatide use. Diabetes Obes Metab 2011, 13(6): 559-66.
86. Drucker, D.J., Sherman, S.I., Bergenstal, R.M., Buse, J.B. The safety of incretin-based therapies - review of the scientific evidence. J Clin Endocrinol Metab 2011, 96(7): 2027-31.
87. Monami, M., Marchionni, N., Mannucci, E. Glucagon-like peptide-1 receptor agonists in type 2 diabetes: a meta-analysis of randomized clinical trials. Eur J Endocrinol 2009, 160(6): 909-17.
88. Byetta(R) approved for use with insulin glargine in the U.S. [news release]. Amylin Pharmaceuticals, Inc.; Eli Lilly and Company, October 19, 2011. http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol- newsArticle&ID=1619235&highlight=. Accessed November 11, 2011.
89. Nathan, D.M., Buse, J.B., Davidson, M.B., Ferrannini, E., Holman, R.R., Sherwin, R., Zinman, B. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009, 32(1): 193-203.
90. National Institute for Health and Clinical Excellence (NICE). Clinical guidelines CG87: Type 2 Diabetes - newer agents (partial update of CG66). May 2009. http://guidance.nice.org.uk/cg87. Accessed November 8, 2011.
91. Best, J.H., Boye, K.S., Rubin, R.R., Cao, D., Kim, T.H., Peyrot, M. Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily. Diabet Med 2009, 26(7): 722-8.
92. Secnik Boye, K., Matza, L.S., Oglesby, A., Malley, K., Kim, S., Hayes, R.P., Brodows, R. Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes. Health Qual Life Outcomes 2006, 4: 80.
93. Best, J.H., Rubin, R.R., Peyrot, M., Li, Y., Yan, P., Malloy, J., Garrison, L.P. Weight-related quality of life, health utility, psychological well-being, and satisfaction with exenatide once weekly compared with sitagliptin or pioglitazone after 26 weeks of treatment. Diabetes Care 2011, 34(2): 314-9.
94. Linnebjerg, H., Seger, M., Kothare, P., Hunt, T.C., Mitchell, M.I. The effect of exenatide on QTc interval in healthy subjects. 69th Annu Meet Sci Sess Am Diabetes Assoc (ADA) (June 5-9, New Orleans) 2009, Abst 597-P.
95. Bydureon(TM) reply submitted to FDA [news release]. Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc., July 28, 2011. http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol- newsArticle&ID=1590148&highlight=. Accessed November 11, 2011.
96. Bydureon(TM) FDA action date set for January 28, 2012 [news release]. Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc., August 10, 2011. http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol- newsArticle&ID=1595289&highlight=. Accessed November 11, 2011.
97. Exenatide tQT study showed no prolongation of QT interval [news release]. Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc., July 7, 2011. http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol- newsArticle&ID=1590148amp;highlight=. Accessed November 11, 2011.
98. Webb, I.G., Williams, R., Marber, M.S. Lizard spit and reperfusion injury. J Am Coll Cardiol 2009, 53(6): 511-3.
99. Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with type 2 diabetes mellitus (NCT01144338). ClinicalTrials.gov Web site, Accessed November 11, 2011.