Exenatide extended-release: A once weekly treatment for patients with type 2 diabetes

Diabetes, Metabolic Syndrome and Obesity

Volumn 7, Issue , 2014, Pages 229-239

  Mann, Katherine V ^a   Raskin, Philip ^b  

^a PharmD Consulting   (United States)

^b UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

GLP 1 receptor agonists; Long acting release; Type 2 diabetes mellitus

Indexed keywords

EXENDIN 4; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; HEMOGLOBIN A1C; INSULIN DETEMIR; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; PLACEBO; SITAGLIPTIN; SULFONYLUREA DERIVATIVE;

ACUTE PANCREATITIS; COMBINATION CHEMOTHERAPY; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; COST UTILITY ANALYSIS; DIARRHEA; DIET RESTRICTION; DIET THERAPY; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG COST; DRUG DOSAGE FORM COMPARISON; DRUG DOSE ESCALATION; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXERCISE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INJECTION SITE PRURITUS; INJECTION SITE REACTION; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; OPTIMAL DRUG DOSE; PHARMACODYNAMICS; POSTPRANDIAL STATE; QUALITY ADJUSTED LIFE YEAR; REVIEW; RHINOPHARYNGITIS; SINGLE DRUG DOSE; TREATMENT OUTCOME; VOMITING;

EID: 84903269924     PISSN: None     EISSN: 11787007     Source Type: Journal    
DOI: 10.2147/DMSO.S35331     Document Type: Review

References (71)

1. Garber AJ, Abrahamson MJ, Barzilay JI, etal. American Association of Clinical Endocrinologists' comprehensive diabetes management algorithm 2013 consensus statement-executive summary. Endocr Pract. 2013;19(3):536-557.
2. Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773-795.
3. DeFronzo RA, Eldor R, Abdul-Ghani M. Pathophysiologic approach to therapy in patients with newly diagnosed type 2 diabetes. Diabetes Care. 2013;36 Suppl 2:S127-S138.
4. Wright EE Jr, Stonehouse AH, Cuddihy RM. In support of an early polypharmacy approach to the treatment of type 2 diabetes. Diabetes Obes Metab. 2010;12(11):929-940.
5. Inzucchi SE, Bergenstal RM, Buse JB, etal; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364-1379.
6. Inzucchi SE, Bergenstal RM, Buse JB, etal. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2012;55(6):1577-1596.
7. Handelsman Y, Mechanick JI, Blonde L, etal; AACE Task Force for Developing Diabetes Comprehensive Care Plan. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011;17 Suppl 2:1-53.
8. Drucker DJ. Incretin-based therapies: a clinical need filled by unique metabolic effects. Diabetes Educ. 2006;32 Suppl 2:65S-71S.
9. Drucker DJ. Enhancing the action of incretin hormones: a new whey forward? Endocrinology. 2006;147(7):3171-3172.
10. Aroda VR, Henry RR, Han J, etal. Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review. Clin Ther. 2012;34(6):1247-1258. e22.
11. Iltz JL, Baker DE, Setter SM, Keith Campbell R. Exenatide: an incretin mimetic for the treatment of type 2 diabetes mellitus. Clin Ther. 2006;28(5):652-665.
12. Stonehouse A, Walsh B, Cuddihy R. Exenatide once-weekly clinical development: safety and efficacy across a range of background therapies. Diabetes Technol Ther. 2011;13(10):1063-1069.
13. Li XC, Zhuo JL. Current insights and new perspectives on the roles of hyperglucagonemia in non-insulin-dependent type 2 diabetes. Curr Hypertens Rep. 2013;15(5):522-530.
14. Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in US diabetes care, 1999-2010. N Engl J Med. 2013;368(17):1613-1624.
15. DeFronzo RA. Current issues in the treatment of type 2 diabetes. Overview of newer agents: where treatment is going. Am J Med. 2010;123(Suppl 3):S38-S48.
16. Zinman B. Initial combination therapy for type 2 diabetes mellitus: is it ready for prime time? Am J Med. 2011;124(Suppl 1):S19-S34.
17. Garber AJ, Abrahamson MJ, Barzilay JI, etal; American Association of Clinical Endocrinologists. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013;19(2):327-336.
18. Nielsen LL, Young AA, Parkes DG. Pharmacology of exenatide (synthetic exendin-4): a potential therapeutic for improved glycemic control of type 2 diabetes. Regul Pept. 2004;117(2):77-88.
19. Brubaker PL, Drucker DJ. Structure-function of the glucagon receptor family of G protein-coupled receptors: the glucagon, GIP, GLP-1, and GLP-2 receptors. Receptors Channels. 2002;8(3-4):179-188.
20. Drucker DJ. Incretin action in the pancreas: potential promise, possible perils, and pathological pitfalls. Diabetes. 2013;62(10):3316-3323.
21. Nielsen LL, Baron AD. Pharmacology of exenatide (synthetic exendin-4) for the treatment of type 2 diabetes. Curr Opin Investig Drugs. 2003;4(4):401-405.
22. DeYoung MB, MacConell L, Sarin V, Trautmann M, Herbert P. Encapsulation of exenatide in poly-(D, L-lactide-co-glycolide) microspheres produced an investigational long-acting once-weekly formulation for type 2 diabetes. Diabetes Technol Ther. 2011;13(11):1145-1154.
23. Fineman M, Flanagan S, Taylor K, etal. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011;50(1):65-74.
24. Drucker DJ, Buse JB, Taylor K, etal. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372(9645):1240-1250.
25. Raskin P, Mohan A. Comparison of once-weekly with twice-daily exenatide in the treatment of type 2 diabetes (DURATION-1 trial). Expert Opin Pharmacother. 2010;11(13):2269-2271.
26. Bergenstal RM, Wysham C, Macconell L, etal; DURATION-2 Study Group. 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):431-439.
27. Diamant M, Van Gaal L, Stranks S, etal. 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):2234-2243.
28. Russell-Jones D, Cuddihy RM, Hanefeld M, etal; DURATION-4 Study Group. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. Diabetes Care. 2012;35(2):252-258.
29. Blevins T, Pullman J, Malloy J, etal. 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):1301-1310.
30. Buse JB, Nauck M, Forst T, etal. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013;381(9861):117-124.
31. Buse JB, Rosenstock J, Sesti G, etal; LEAD-6 Study Group. 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.
32. Buse JB, Drucker DJ, Taylor KL, etal; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33(6): 1255-1261.
33. 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.
34. Davies M, Heller S, Sreenan S, etal. Once-weekly exenatide versus once-or twice-daily insulin detemir: randomized, open-label, clinical trial of efficacy and safety in patients with type 2 diabetes treated with metformin alone or in combination with sulfonylureas. Diabetes Care. 2013;36(5):1368-1376.
35. Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012;34(9):1892-1908. e1891.
36. Cui YM, Guo XH, Zhang DM, etal. Pharmacokinetics, safety, and tolerability of single-and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus. J Diabetes. 2013;5(2): 127-135.
37. Bergenstal RM, Li Y, Porter TK, Weaver C, Han J. Exenatide once weekly improved glycaemic control, cardiometabolic risk factors and a composite index of an HbA1c-7%, without weight gain or hypoglycaemia, over 52 weeks. Diabetes Obes Metab. 2013;15(3):264-271.
38. Wysham C, Bergenstal R, Malloy J, etal. DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Diabetic Med. 2011;28(6):705-714.
39. Pencek R, Blickensderfer A, Li Y, Brunell SC, Chen S. Exenatide once weekly for the treatment of type 2 diabetes: effectiveness and tolerability in patient subpopulations. Int J Clin Pract. 2012;66(11):1021-1032.
40. Alves C, Batel Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitus and cancer. Diab Res Clin Pract. 2012 Nov;98(2):271-284.
41. Chiquette E, Toth PP, Ramirez G, Cobble M, Chilton R. Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers. Vasc Health Risk Manag. 2012;8:621-629.
42. Robinson LE, Holt TA, Rees K, Randeva HS, O'Hare JP. Effects of exenatide and liraglutide on heart rate, blood pressure and body weight: systematic review and meta-analysis. BMJ Open. 2013;3(1). pii: e001986.
43. Turton MD, O'Shea D, Gunn I, etal. A role for glucagon-like peptide-1 in the central regulation of feeding. Nature. 1996;379(6560):69-72.
44. Flint A, Kapitza C, Zdravkovic M. The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment. Diabetes Obes Metab. 2013;15(10):958-962.
45. Tatarkiewicz K, Belanger P, Gu G, Parkes D, Roy D. No evidence of drug-induced pancreatitis in rats treated with exenatide for 13 weeks. Diabetes Obes Metab. 2013;15(5):417-426.
46. Extended-release exenatide (Bydureon) for type 2 diabetes. Med Lett Drugs Ther. 2012;54(1386):21-23.
47. Butler AE, Campbell-Thompson M, Gurlo T, Dawson DW, Atkinson M, Butler PC. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013;62(7):2595-2604.
48. Bonner-Weir S, In't Veld PA, Weir GC. Reanalysis of study of pancreatic effects of incretin therapy: methodological deficiencies. Diabetes Obes Metab. Epub January 8, 2014.
49. Garg R, Chen W, Pendergrass M. Acute pancreatitis in type 2 diabetes treated with exenatide or sitagliptin: a retrospective observational pharmacy claims analysis. Diabetes Care. Nov 2010;33(11):2349-2354.
50. Romley JA, Goldman DP, Solomon M, McFadden D, Peters AL. Exenatide therapy and the risk of pancreatitis and pancreatic cancer in a privately insured population. Diabetes Technol Ther. 2012;14(10): 904-911.
51. FDA. [Homepage on the Internet]. Incretin and Pancreatitis. http://www.fda.com/. Accessed 10 June 2014.
52. EMA. [Homepage on the Internet]. Pancreatitis: Incretins. http://www.ema.europa.eu/ema/. Accessed 10 June 2014.
53. Egan AG, Blind E, Dunder K, etal. Pancreatic safety of incretin-based drugs-FDA and EMA assessment. N Engl J Med. 2014;370(9): 794-797.
54. Bulchandani D, Nachnani JS, Herndon B, etal. Effect of exendin (exenatide)-GLP 1 receptor agonist on the thyroid and parathyroid gland in a rat model. Eur J Pharmacol. 2012;691(1-3):292-296.
55. Bjerre Knudsen L, Madsen LW, Andersen S, etal. Glucagon-like Peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology. 2010;151(4):1473-1486.
56. Fineman MS, Mace KF, Diamant M, etal. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012;14(6):546-554.
57. Faludi P, Brodows R, Burger J, Ivanyi T, Braun DK. The effect of exenatide re-exposure on safety and efficacy. Peptides. 2009;30(9):1771-1774.
58. Ridge T, Moretto T, Macconell L, etal. Comparison of safety and tolerability with continuous (exenatide once weekly) or intermittent (exenatide twice daily) GLP-1 receptor agonism in patients with type 2 diabetes. Diabetes Obes Metab. 2012;14(12):1097-1103.
59. Norwood P, Liutkus JF, Haber H, Pintilei E, Boardman MK, Trautmann ME. Safety of exenatide once weekly in patients with type 2 diabetes mellitus treated with a thiazolidinedione alone or in combination with metformin for 2 years. Clin Ther. 2012;34(10):2082-2090.
60. Polonsky WH, Fisher L, Hessler D, Bruhn D, Best JH. Patient perspectives on once-weekly medications for diabetes. Diabetes Obes Metab. 2011;13(2):144-149.
61. Aroda VR, DeYoung MB. Clinical implications of exenatide as a twice-daily or once-weekly therapy for type 2 diabetes. Postgrad Med. 2011;123(5):228-238.
62. Best JH, Boye KS, Rubin RR, Cao D, Kim TH, Peyrot M. Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily. Diabet Med. 2009;26(7):722-728.
63. Secnik Boye K, Matza LS, Oglesby A, etal. 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.
64. Beaudet A, Palmer JL, Timlin L, etal. Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in the UK. J Med Econ. 2011;14(3):357-366.
65. Guillermin AL, Lloyd A, Best JH, DeYoung MB, Samyshkin Y, Gaebler JA. Long-term cost-consequence analysis of exenatide once weekly vs sitagliptin or pioglitazone for the treatment of type 2 diabetes patients in the United States. J Med Econ. 2012;15(4):654-663.
66. Samyshkin Y, Guillermin AL, Best JH, Brunell SC, Lloyd A. Long-term cost-utility analysis of exenatide once weekly versus insulin glargine for the treatment of type 2 diabetes patients in the US. J Med Econ. 2012;15 Suppl 2:6-13.
67. Buse JB, Bergenstal RM, Glass LC, etal. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011;154(2):103-112.
68. Arnolds S, Dellweg S, Clair J, etal. Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study. Diabetes Care. 2010;33(7):1509-1515.
69. Li CJ, Li J, Zhang QM, etal. Efficacy and safety comparison between liraglutide as add-on therapy to insulin and insulin dose-increase in Chinese subjects with poorly controlled type 2 diabetes and abdominal obesity. Cardiovasc Diabetol. 2012;11:142.
70. Riddle MC, Forst T, Aronson R, etal. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013;36(9):2497-2503.
71. Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013;36(9):2559-2565.