BYDUREON® (exenatide)

Bydureon® (exenatide suspensie met verlengde afgifte voor injectie in voorafgevulde pen) is een eenmaal per week te injecteren receptoragonist van glucagonachtig peptide-1 (GLP-1), beschikbaar als pen met één dosis, geïndiceerd ter verbetering van de glykemische controle bij volwassenen met diabetes type 2. Beschikbaar als 2 mg poeder en oplosmiddel voor suspensie met verlengde afgifte voor injectie.


  1. Henry RR, Klein EJ, Han J, Iqbal N. Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study. Diabetes Technol Ther. 2016;18(11):677-686.
  2. Diamant M, Van GL, Guerci B, et al. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2(6):464-473.
  3. Bydureon Pen, Samenvatting van de productkenmerken, meest recente versie
  4. Gearchiveerde gegevens, AstraZeneca Pharmaceuticals LP, 3211825. 2016.
  5. Drucker DJ, Buse JB, Taylor K, et al. 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.
  6. Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015;90(3):356-365.
  7. Buse JB, Drucker DJ, Taylor KL, et al. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010;33(6):1255-1261.
  8. Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41.
  9. LaRue S, Malloy J. Evaluation of the Dual-Chamber Pen Design for the Injection of Exenatide Once Weekly for the Treatment of Type 2 Diabetes. J Diabetes Sci Technol. 2015;9(4):815-821.
  10. Diamant M, Van GL, Stranks S, et al. 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.
  11. Hauber AB, Nguyen H, Posner J, Ervin C, LaRue S, Kalsekar I. Patient preferences for frequency of glucagon-like peptide-1 receptor agonist (GLP-1RA) injections in the treatment of type 2 diabetes. Poster-presentatie tijdens: 19e jaarlijkse internationale bijeenkomst van de International Society for Pharmacoeconomics and Outcomes Research; mei 31-juni 4, 2014; Montreal, Quebec, Canada. Poster-presentatie. 2016.
  12. 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.
  13. 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):1301-1310.
  14. Buse JB, Nauck M, Forst T, et al. 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.
  15. Trautman ME. Trautmann ME, Van Gaal L, Han J, Hardy E. Three-year efficacy and safety of exenatide once weekly: a pooled analysis of 3 trials. Poster gepresenteerd tijdens: 51st Jaarlijks Congres van de Europese Associatie voor Diabetesonderzoek; 14-18 september, 2015. Stockholm, Zweden. Poster. 2016.
  16. Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016;39(suppl 1):S1-S119. Diabetes Care. 2016.
  17. Lantus samenvatting van de productkenmerken. 2015. 2016.
  18. Pistrosch et al. Pistrosch F, Köhler C, Schaper F, Landgraf W, Forst T, Hanefeld M. Effects of insulin glargine versus metformin on glycemic variability, microvascular and beta-cell function in early type 2 diabetes. Acta Diabetol. 2013;50(4):587-595. 2017. 
  19. Gearchiveerde gegevens, AstraZeneca Pharmaceuticals LP, 3150204. 2016. 
  20. Aronoff SL, Berkowitz K, Shreiner B, Want L. Glucose metabolism andregulation: beyond insulin and glucagon. Diabetes Spectrum. 2004;17(3):183-190. Diabetes Spectrum. 2016.
  21. Lim GE, Brubaker PL. Glucagon-like peptide 1 secretion by the L-cell: the view from within. Diabetes. 2006;55(suppl 2):S70-S77. Diabetes. 2016.
  22. 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.
  23. Astrazeneca Pharmaceuticals LP. Core periodic Benefit-Risk Evaluation Report (20). 2016.Gearchiveerde gegevens, AstraZeneca Pharmaceuticals LP, 993604.011. 2016.
  24. Clinical Clinical Trials gov.
  25. Amerikaanse Nationale Bibliotheek voor Geneeskunde. Amerikaans Nationaal Gezondheidsinstituut. www ncbi nlm nih gov. Geraadpleegd 25 september 2015.
  26. Wysham CH, et al. Poster 1041-P. Presented at the American Diabetes Association’s 76th Scientific Sessions (ADA 2016), New Orleans, LA, June 40-14, 2016
  27. Klein EJ. Klein EJ, Henry RR, Malloy J, et al. DURATION-1 extension: efficacy and tolerability of exenatide once weekly over 6 years in patients with type 2 diabetes mellitus. Poster gepresenteerd tijdens: 50e Jaarlijks Congres van de Europese Associatie voor Diabetesonderzoek; 15-19 augustus, 2014; Wenen, Oostenrijk. Poster. 2016.
  28. Johnston SS, Nguyen H, Felber E, et al. Retrospective study of adherence to glucagon-like peptide-1 receptor agonist therapy in patients with type 2 diabetes mellitus in the United States. Adv Ther. 2014;31(11):1119-1133.
  29. Monnier L, Colette C, Owens D. Postprandial and basal glucose in type 2 diabetes: assessment and respective impacts. Diabetes Technol Ther. 2011;13 Suppl 1:S25-S32.
  30. 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 HbA(1c). Diabetes Care. 2003;26(3):881-885.
  31. Riddle M, Umpierrez G, DiGenio A, Zhou R, Rosenstock J. Contributions of basal and postprandial hyperglycemia over a wide range of A1C levels before and after treatment intensification in type 2 diabetes. Diabetes Care. 2011;34(12):2508-2514.
  32. Giugliano D, Maiorino MI, Bellastella G, Chiodini P, Ceriello A, Esposito K. Efficacy of insulin analogs in achieving the hemoglobin A1c target of <7% in type 2 diabetes: meta-analysis of randomized controlled trials. Diabetes Care. 2011;34(2):510-517.
  33. Vaag A, Lund SS. Insulin initiation in patients with type 2 diabetes mellitus: treatment guidelines, clinical evidence and patterns of use of basal vs premixed insulin analogues. Eur J Endocrinol. 2012;166(2):159-170.
  34. Bergenstal RM, 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):431-439.
  35. Diamant et al. Extra bijlage bij: Diamant M, Van Gaal L, Guerci B, et al. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014;2(6):1-12. Extra bijlage. 2016.
  36. 3024913. Gearchiveerde gegevens, AstraZeneca Pharmaceuticals LP, 3024913. 2016
  37. Gegevens uit dossier. AstraZeneca Pharmaceuticals LP, 3123823. 2016.

NS ID BE-1052-RD05/2017-WEB Local code 660