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References

  • 1
    Kendall DM, Kim D, Maggs D. Incretin mimetics and dipeptidyl peptidase-IV inhibitors: a review of emerging therapies for type 2 diabetes. Diabetes Technol Ther 2006; 8: 385396.
  • 2
    Drucker DJ, Buse JB, Taylor K, Kendall DM, 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: 12401250.
  • 3
    Blevins T, Pullman J, Malloy J, Yan P, Taylor K, Schulteis C, Trautmann M, Porter L. 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: 13011310.
  • 4
    Diamant M, Van Gaal L, Stranks S, Northup 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: 22342243.
  • 5
    Bergenstal RM, Wysham C, Macconell L, Malloy J, Walsh B, Yan P, Wilhelm K, Malone J, Porter LE. 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: 431439.
  • 6
    Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. 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: 275286.
  • 7
    Darpö B. The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance. Br J Pharmacol 2010; 159: 4957.
  • 8
    Food and Drug Administration. Guidance for Industry: E14 Clinical Evaluation of QT/Qtc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. [FDA Guidance]. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, 2005.
  • 9
    Linnebjerg H, Seger M, Kothare PA, Hunt T, Wolka AM, Mitchell MI. A thorough QT study to evaluate the effects of single dose exenatide 10 μg on cardiac repolarization in healthy subjects. Int J Clin Pharmacol Ther 2011; 49: 594604.
  • 10
    Sager P, Darpö B, Han J, Kothare P, Linneberg H, Mitchell M, Porter L. Exenatide once weekly did not affect corrected QT interval in patients with type 2 diabetes. Diabetes 2011; 60: A294.
  • 11
    Amylin Pharmaceuticals Inc. BYETTA® Exenatide Injection. [Prescribing Information]. San Diego, CA: Amylin Pharmaceuticals, Inc., 2010.
  • 12
    Linnebjerg H, Kothare PA, Seger M, Wolka AM, Mitchell MI. Exenatide – pharmacokinetics, pharmacodynamics, safety and tolerability in patients ≥75 years of age with type 2 diabetes. Int J Clin Pharmacol Ther 2011; 49: 99108.
  • 13
    Linnebjerg H, Kothare PA, 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: 317327.
  • 14
    Adler AI, Stevens RJ, Manley SE, Bilous RW, Cull CA, Holman RR. Development and progression of nephropathy in type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS 64). Kidney Int 2003; 63: 225232.
  • 15
    Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR, LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009; 32: 8490.
  • 16
    Okerson T, Chilton RJ. The cardiovascular effects of GLP-1 receptor agonists. Cardiovasc Ther 2010; 30: e146155.
  • 17
    Tornøe CW, Garnett CE, Wang Y, Florian J, Li M, Gobburu JV. Creation of a knowledge management system for QT analyses. J Clin Pharmacol 2011; 51: 10351042.
  • 18
    Williams EJ. Experimental designs balanced for the estimation of residual effects of treatments. Aust J Sci Res 1949; 2: 149168.
  • 19
    World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925926.
  • 20
    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 metformin and/or sulfonylurea treatment in patients with type 2 diabetes. Diabetes Care 2003; 26: 23702377.
  • 21
    Fridericia LS. The duration of systole in an electrocardiogram in normal humans and in patients with heart disease. Ann Noninvasive Electrocardiol 2003; 8: 343351.
  • 22
    Tobias RD, Rom D, Wolfinger RD, Hochberg Y. Multiple comparisons among treatment means in the general linear model. In: Multiple comparisons and multiple tests using the SAS system, edWestfall PH, 1999.
  • 23
    Liu H, Zheng Y, Shen J. Goodness-of-fit measures of R2 for repeated measures mixed effect models. J Appl Stat 2008; 35: 10811092.
  • 24
    Florian JA, Tornoe CW, Brundage R, Parekh A, Garnett CE. Population pharmacokinetic and concentration-QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies. J Clin Pharmacol 2011; 51: 11521162.
  • 25
    Chatterjee DJ, Khutoryansky N, Zdravkovic M, Sprenger CR, Litwin JS. Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes. J Clin Pharmacol 2009; 49: 13531362.
  • 26
    Gill A, Hoogwerf BJ, Burger J, Bruce S, Macconell L, Yan P, Braun D, Giaconia J, Malone J. Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc Diabetol 2010; 9: 6.
  • 27
    Malik M, Garnett CE, Zhang J. Thorough QT studies: questions and quandaries. Drug Saf 2010; 33: 114.
  • 28
    Garnett CE, Zhu H, Malik M, Fossa AA, Zhang J, Badilini F, Li J, Darpö B, Sager P, Rodriguez I. Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects. Am Heart J 2012; 163: 912930.
  • 29
    Taubel J, Wong AH, Naseem A, Ferber G, Camm AJ. Shortening of the QT interval after food can be used to demonstrate assay sensitivity in thorough QT studies. J Clin Pharmacol 2011. doi: 10.1177/0091270011419851. [Epub ahead of print].
  • 30
    Amylin Pharmaceuticals Inc. BYDUREON® (Exenatide Extended-Release for Injectable Suspension). [Prescribing Information]. San Diego, CA: Amylin Pharmaceuticals Inc., 2012.