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Volumn 49, Issue 10, 2011, Pages 594-605

A thorough QT study to evaluate the effects of single-dose exenatide 10 μg on cardiac repolarization in healthy subjects

Author keywords

Exenatide; ICH E14; Moxifloxacin; QTc; Thorough QT

Indexed keywords

EXENDIN 4; GLUCOSE; INSULIN; MOXIFLOXACIN; PLACEBO;

EID: 80053606722     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201462     Document Type: Article
Times cited : (29)

References (25)
  • 1
    • 48749089599 scopus 로고    scopus 로고
    • Emerging incretin based therapies for type 2 diabetes: Incretin mimetics and DPP-4 inhibitors
    • doi: 10.2174/157339908784220705 PubMed
    • Stonehouse A, Okerson T, Kendall D, Maggs D. Emerging incretin based therapies for type 2 diabetes: incretin mimetics and DPP-4 inhibitors. Curr Diabetes Rev. 2008; 4: 101-109. doi: 10.2174/157339908784220705 PubMed
    • (2008) Curr Diabetes Rev , vol.4 , pp. 101-109
    • Stonehouse, A.1    Okerson, T.2    Kendall, D.3    Maggs, D.4
  • 2
    • 67649331128 scopus 로고    scopus 로고
    • Accessed 04 February 2011
    • Byetta prescribing information. http://pi.lilly.com/us/byetta-pi.pdf. Accessed 04 February 2011.
    • Byetta Prescribing Information
  • 5
    • 48149102347 scopus 로고    scopus 로고
    • The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: E14
    • Accessed 04 February 2011
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: E14. 2005. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ ucm129357.pdf. Accessed 04 February 2011.
    • (2005) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • 6
    • 17644401388 scopus 로고    scopus 로고
    • Pharmacokinetics of an oral drug (acetaminophen) administered at various times in relation to subcutaneous injection of exenatide (exendin-4) in healthy subjects
    • DOI 10.1177/0091270004274432
    • Blase E, Taylor K, Gao HY, Wintle M, Fineman M. Pharmacokinetics of an oral drug (acetaminophen) administered at various times in relation to subcutaneous injection of exenatide (exendin-4) in healthy subjects. J Clin Pharmacol. 2005; 45: 570-577. doi: 10.1177/0091270004274432 PubMed (Pubitemid 40562948)
    • (2005) Journal of Clinical Pharmacology , vol.45 , Issue.5 , pp. 570-577
    • Blase, E.1    Taylor, K.2    Gao, H.-Y.3    Wintle, M.4    Fineman, M.5
  • 8
    • 33748637338 scopus 로고    scopus 로고
    • Effect of exenatide on the pharmacokinetics and pharmacodynamics of warfarin in healthy Asian men
    • DOI 10.1177/0091270006291622
    • Soon D, Kothare PA, Linnebjerg H, Park S, Yuen E, Mace KF, Wise SD. Effect of exenatide on the pharmacokinetics and pharmacodynamics of warfarin in healthy Asian men. J Clin Pharmacol. 2006; 46: 1179-1187. doi: 10.1177/0091270006291622 PubMed (Pubitemid 44387418)
    • (2006) Journal of Clinical Pharmacology , vol.46 , Issue.10 , pp. 1179-1187
    • Soon, D.1    Kothare, P.A.2    Linnebjerg, H.3    Park, S.4    Yuen, E.5    Mace, K.F.6    Wise, S.D.7
  • 9
    • 18144401971 scopus 로고    scopus 로고
    • Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2
    • DOI 10.2337/diacare.28.5.1092
    • DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. 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: 1092-1100. doi: 10.2337/diacare.28.5.1092 PubMed (Pubitemid 40616618)
    • (2005) Diabetes Care , vol.28 , Issue.5 , pp. 1092-1100
    • DeFronzo, R.A.1    Ratner, R.E.2    Han, J.3    Kim, D.D.4    Fineman, M.S.5    Baron, A.D.6
  • 10
    • 4644300651 scopus 로고    scopus 로고
    • Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing dose-limiting side effects in subjects with type 2 diabetes
    • DOI 10.1002/dmrr.499
    • Fineman MS, Shen LZ, Taylor K, Kim DD, Baron AD. Effectiveness of progressive dose-escalation of exenatide (exendin-4) in reducing dose-limiting side effects in subjects with type 2 diabetes. Diabetes Metab Res Rev. 2004; 20: 411-417. doi: 10.1002/dmrr.499 PubMed (Pubitemid 39302967)
    • (2004) Diabetes/Metabolism Research and Reviews , vol.20 , Issue.5 , pp. 411-417
    • Fineman, M.S.1    Shen, L.Z.2    Taylor, K.3    Kim, D.D.4    Baron, A.D.5
  • 11
    • 17144371646 scopus 로고    scopus 로고
    • Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea
    • DOI 10.2337/diacare.28.5.1083
    • Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. 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: 1083-1091. doi:10.2337/diacare.28.5.1083 PubMed (Pubitemid 40616617)
    • (2005) Diabetes Care , vol.28 , Issue.5 , pp. 1083-1091
    • Kendall, D.M.1    Riddle, M.C.2    Rosenstock, J.3    Zhuang, D.4    Kim, D.D.5    Fineman, M.S.6    Baron, A.D.7
  • 12
    • 1542786569 scopus 로고    scopus 로고
    • The duration of systole in an electrocardiogram in normal humans and in patients with heart disease
    • DOI 10.1046/j.1542-474X.2003.08413.x
    • Fridericia LS. The duration of systole in an electrocardiogram in normal humans and in patients with heart disease. 1920. Ann Noninvasive Electrocardiol. 2003; 8: 343-351. doi: 10.1046/j.1542-474X.2003.08413.x PubMed (Pubitemid 38569971)
    • (2003) Annals of Noninvasive Electrocardiology , vol.8 , Issue.4 , pp. 343-351
    • Fridericia, L.S.1
  • 13
    • 0030874319 scopus 로고    scopus 로고
    • Altered ventricular repolarization during hypoglycaemia in patients with diabetes
    • DOI 10.1002/(SICI)1096-9136(199708)14:8<648::AID-DIA418>3.0.CO;2-1
    • Marques JL, George E, Peacey SR, Harris ND, Macdonald IA, Cochrane T, Heller SR. Altered ventricular repolarization during hypoglycaemia in patients with diabetes. Diabet Med. 1997; 14: 648-654. doi: 10.1002/(SICI)1096- 9136(199708)14:8〈648::AID-DIA418〉3.0.CO:2-1 PubMed (Pubitemid 27346853)
    • (1997) Diabetic Medicine , vol.14 , Issue.8 , pp. 648-654
    • Marques, J.L.B.1    George, E.2    Peacey, S.R.3    Harris, N.D.4    Macdonald, I.A.5    Cochrane, T.6    Heller, S.R.7
  • 14
    • 0031793981 scopus 로고    scopus 로고
    • Hypoglycaemia leads to an increased QT interval in normal men
    • DOI 10.1046/j.1365-2281.1998.00138.x
    • Eckert B, Agardh CD. Hypoglycaemia leads to an increased QT interval in normal men. Clin Physiol. 1998; 18: 570-575. doi: 10.1046/j.1365-2281.1998. 00138.x PubMed (Pubitemid 28488455)
    • (1998) Clinical Physiology , vol.18 , Issue.6 , pp. 570-575
    • Eckert, B.1    Agardh, C.-D.2
  • 15
    • 0034113020 scopus 로고    scopus 로고
    • The effect of acute hyperglycaemia on QTc duration in healthy man
    • DOI 10.1007/s001250051345
    • Marfella R, Nappo F, De Angelis L, Siniscalchi M, Rossi F, Giugliano D. The effect of acute hyperglycaemia on QTc duration in healthy man. Daibetologia. 2000; 43: 571-575. doi: 10.1007/s001250051345 PubMed (Pubitemid 30322074)
    • (2000) Diabetologia , vol.43 , Issue.5 , pp. 571-575
    • Marfella, R.1    Nappo, F.2    De Angelis, L.3    Siniscalchi, M.4    Rossi, F.5    Giugliano, D.6
  • 16
    • 0032875210 scopus 로고    scopus 로고
    • Increased QT dispersion during hypoglycaemia in patients with type 2 diabetes mellitus
    • DOI 10.1046/j.1365-2796.1999.00528.x
    • Landstedt-Hallin L, Englund A, Adamson U, Lins PE. Increased QT dispersion during hypoglycaemia in patients with type 2 diabetes mellitus. J Intern Med. 1999; 246: 299-307. doi: 10.1046/j.1365-2796.1999.00528.x PubMed (Pubitemid 29426449)
    • (1999) Journal of Internal Medicine , vol.246 , Issue.3 , pp. 299-307
    • Landstedt-Hallin, L.1    Englund, A.2    Adamson, U.3    Lins, P.-E.4
  • 18
    • 0001127258 scopus 로고
    • An analysis of time-relations of electrocardiograms
    • Bazett HC. An analysis of time-relations of electrocardiograms. Heart. 1920; 7: 353-370.
    • (1920) Heart , vol.7 , pp. 353-370
    • Bazett, H.C.1
  • 19
    • 45849106884 scopus 로고    scopus 로고
    • Sample size calculations in thorough QT studies
    • DOI 10.1080/10543400801993002, PII 793009797
    • Zhang L, Dmitrienko A, Luta G. Sample size calculations in thorough QT studies. J Biopharm Stat. 2008; 18: 468-482. doi: 10.1080/10543400801993002 PubMed (Pubitemid 351891686)
    • (2008) Journal of Biopharmaceutical Statistics , vol.18 , Issue.3 , pp. 468-482
    • Zhang, L.1    Dmitrienko, A.2    Luta, G.3
  • 21
    • 0037850667 scopus 로고    scopus 로고
    • Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metformin and/or sulfonylurea treatment in patients with type 2 diabetes
    • DOI 10.2337/diacare.26.8.2370
    • Fineman MS, Bicsak TA, Shen LZ, Taylor K, Gaines E, Varns A, Kim D, Baron AD. Effect on glycemic control of exenatide (synthetic exendin-4) additive to existing metfonnin and/or sulfonylurea treatment in patients with type 2 diabetes. Diabetes Care. 2003; 26: 2370-2377. doi: 10.2337/diacare.26.8.2370 PubMed (Pubitemid 36993328)
    • (2003) Diabetes Care , vol.26 , Issue.8 , pp. 2370-2377
    • Fineman, M.S.1    Bicsak, T.A.2    Shen, L.Z.3    Taylor, K.4    Gaines, E.5    Varns, A.6    Kim, D.7    Baron, A.D.8
  • 24
    • 84857102676 scopus 로고    scopus 로고
    • Accessed 04 February 2011
    • Avelox prescribing information. http://www.avelox.com/html/pdf/avelox- prescribing.pdf. Accessed 04 February 2011.
    • Avelox Prescribing Information
  • 25


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.