메뉴 건너뛰기




Volumn 5, Issue 2, 2013, Pages 127-135

Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus

Author keywords

Chinese; Diabetes; Exenatide; Glucagon like peptide 1; Pharmacokinetics

Indexed keywords

EXENDIN 4; GLUCOSE; HEMOGLOBIN A1C; METFORMIN;

EID: 84877020930     PISSN: 17530393     EISSN: 17530407     Source Type: Journal    
DOI: 10.1111/1753-0407.12020     Document Type: Article
Times cited : (20)

References (24)
  • 1
    • 77950263954 scopus 로고    scopus 로고
    • Prevalence of diabetes among men and women in China
    • Yang W, Lu J, Weng J etal. Prevalence of diabetes among men and women in China. N Engl J Med. 2010; 362: 1090-1101.
    • (2010) N Engl J Med , vol.362 , pp. 1090-1101
    • Yang, W.1    Lu, J.2    Weng, J.3
  • 2
    • 0032511583 scopus 로고    scopus 로고
    • Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)
    • UK Prospective Diabetes Study (UKPDS) Group
    • UK Prospective Diabetes Study (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: 837-853.
    • (1998) Lancet , vol.352 , pp. 837-853
  • 3
    • 0034641568 scopus 로고    scopus 로고
    • Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study
    • Stratton IM, Adler AI, Neil HA etal. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study. BMJ. 2000; 321: 405-412.
    • (2000) BMJ , vol.321 , pp. 405-412
    • Stratton, I.M.1    Adler, A.I.2    Neil, H.A.3
  • 4
    • 0347360186 scopus 로고    scopus 로고
    • Pharmacology of exenatide (synthetic exendin-4): A potential therapeutic for improved glycemic control of type 2 diabetes
    • 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: 77-88.
    • (2004) Regul Pept , vol.117 , pp. 77-88
    • Nielsen, L.L.1    Young, A.A.2    Parkes, D.G.3
  • 5
    • 0034814047 scopus 로고    scopus 로고
    • Exendin-4 reduces fasting and postprandial glucose and decreases energy intake in healthy volunteers
    • Edwards CM, Stanley SA, Davis R etal. Exendin-4 reduces fasting and postprandial glucose and decreases energy intake in healthy volunteers. Am J Physiol Endocrinol Metab. 2001; 281: E155-161.
    • (2001) Am J Physiol Endocrinol Metab , vol.281
    • Edwards, C.M.1    Stanley, S.A.2    Davis, R.3
  • 6
    • 0036965113 scopus 로고    scopus 로고
    • The insulinotropic effect of acute exendin-4 administered to humans: Comparison of nondiabetic state to type 2 diabetes
    • Egan JM, Clocquet AR, Elahi D. The insulinotropic effect of acute exendin-4 administered to humans: Comparison of nondiabetic state to type 2 diabetes. J Clin Endocrinol Metab. 2002; 87: 1282-1290.
    • (2002) J Clin Endocrinol Metab , vol.87 , pp. 1282-1290
    • Egan, J.M.1    Clocquet, A.R.2    Elahi, D.3
  • 7
    • 0038497464 scopus 로고    scopus 로고
    • Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes
    • Kolterman OG, Buse JB, Fineman MS etal. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab. 2003; 88: 3082-3089.
    • (2003) J Clin Endocrinol Metab , vol.88 , pp. 3082-3089
    • Kolterman, O.G.1    Buse, J.B.2    Fineman, M.S.3
  • 8
    • 84877083664 scopus 로고    scopus 로고
    • European Medicines Agency. Bydureon: European public assessment report: Summary for the public. Available from: (accessed 22 Janaury 2013)
    • European Medicines Agency. Bydureon: European public assessment report: Summary for the public. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002020/human_med_001457.jsp&mid=WC0b01ac058001d124 (accessed 22 Janaury 2013).
  • 9
    • 84877018786 scopus 로고    scopus 로고
    • US Food and Drug Administration. Bydureon: Drug details: Label information. Available from: (accessed 22 January 2013)
    • US Food and Drug Administration. Bydureon: Drug details: Label information. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails (accessed 22 January 2013).
  • 10
    • 52149111848 scopus 로고    scopus 로고
    • Exenatide pharmacokinetics in healthy Chinese subjects
    • Zhao X, Cui YM, Zhou Y etal. Exenatide pharmacokinetics in healthy Chinese subjects. Int J Clin Pharmacol Ther. 2008; 46: 459-465.
    • (2008) Int J Clin Pharmacol Ther , vol.46 , pp. 459-465
    • Zhao, X.1    Cui, Y.M.2    Zhou, Y.3
  • 11
    • 34249891874 scopus 로고    scopus 로고
    • 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
    • Kim D, MacConell L, Zhuang D etal. 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: 1487-1493.
    • (2007) Diabetes Care , vol.30 , pp. 1487-1493
    • Kim, D.1    MacConell, L.2    Zhuang, D.3
  • 12
    • 53249142132 scopus 로고    scopus 로고
    • Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: A randomised, open-label, non-inferiority study
    • 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: 1240-1250.
    • (2008) Lancet , vol.372 , pp. 1240-1250
    • Drucker, D.J.1    Buse, J.B.2    Taylor, K.3
  • 13
    • 77953859640 scopus 로고    scopus 로고
    • Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): An open-label randomised trial
    • 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: 2234-2243.
    • (2010) Lancet , vol.375 , pp. 2234-2243
    • Diamant, M.1    Van Gaal, L.2    Stranks, S.3
  • 14
    • 82955231168 scopus 로고    scopus 로고
    • Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naïve patients with type 2 diabetes
    • Abstract
    • Cuddihy RM, Russell-Jones D, Hanefeld M etal. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naïve patients with type 2 diabetes. Diabetes. 2011; 60 (Suppl. 1): A77 (Abstract).
    • (2011) Diabetes , vol.60 , Issue.SUPPL. 1
    • Cuddihy, R.M.1    Russell-Jones, D.2    Hanefeld, M.3
  • 15
    • 79955661908 scopus 로고    scopus 로고
    • DURATION 5: Exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes
    • 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: 1301-1310.
    • (2011) J Clin Endocrinol Metab , vol.96 , pp. 1301-1310
    • Blevins, T.1    Pullman, J.2    Malloy, J.3
  • 16
    • 77955573674 scopus 로고    scopus 로고
    • 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 randomized trial
    • Bergenstal RM, Wysham C, MacConell L etal. 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 randomized trial. Lancet. 2010; 376: 431-439.
    • (2010) Lancet , vol.376 , pp. 431-439
    • Bergenstal, R.M.1    Wysham, C.2    MacConell, L.3
  • 17
    • 84872084453 scopus 로고    scopus 로고
    • Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): A randomised, open-label study
    • 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. 2012; 381: 117-124.
    • (2012) Lancet , vol.381 , pp. 117-124
    • Buse, J.B.1    Nauck, M.2    Forst, T.3
  • 19
    • 84860250733 scopus 로고    scopus 로고
    • Clinical relevance of anti-exenatide antibodies: Safety, efficacy, and cross-reactivity with long-term treatment
    • 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: 546-554.
    • (2012) Diabetes Obes Metab , vol.14 , pp. 546-554
    • Fineman, M.S.1    Mace, K.F.2    Diamant, M.3
  • 20
    • 73549096393 scopus 로고    scopus 로고
    • Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes
    • Iwamoto K, Nasu R, Yamamura A etal. Safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once weekly in Japanese patients with type 2 diabetes. Endocr J. 2009; 56: 951-962.
    • (2009) Endocr J , vol.56 , pp. 951-962
    • Iwamoto, K.1    Nasu, R.2    Yamamura, A.3
  • 21
    • 78649911161 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing
    • Fineman M, Flanagan S, Taylor K etal. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011; 50: 65-74.
    • (2011) Clin Pharmacokinet , vol.50 , pp. 65-74
    • Fineman, M.1    Flanagan, S.2    Taylor, K.3
  • 22
    • 84877047186 scopus 로고    scopus 로고
    • US Food and Drug Administration. Byetta® (Exenatide) injection full prescribing information. Available from: (accessed 20 February 2012)
    • US Food and Drug Administration. Byetta® (Exenatide) injection full prescribing information. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=BYETTA&CFID=7882409&CFTOKEN=bfd96f44989db3cc-55032381-F625-B480-0D39DC2F4283AF5B (accessed 20 February 2012).
  • 23
    • 84877053630 scopus 로고    scopus 로고
    • International Conference on Harmonisation. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Ethnic Factors in the Acceptability of Foreign Clinical Data e5(r1). Available from: (accessed 16 September 2011)
    • International Conference on Harmonisation. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline. Ethnic Factors in the Acceptability of Foreign Clinical Data e5(r1). 1998 Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E5_R1/Step4/E5_R1__Guideline.pdf (accessed 16 September 2011).
    • (1998)
  • 24
    • 57449094967 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics, tolerability, and safety of exenatide in Japanese patients with type 2 diabetes mellitus
    • Kothare PA, Linnebjerg H, Isaka Y etal. Pharmacokinetics, pharmacodynamics, tolerability, and safety of exenatide in Japanese patients with type 2 diabetes mellitus. J Clin Pharmacol. 2008; 48: 1389-1399.
    • (2008) J Clin Pharmacol , vol.48 , pp. 1389-1399
    • Kothare, P.A.1    Linnebjerg, H.2    Isaka, Y.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.