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Xenobiotica
the fate of foreign compounds in biological systems
Volume 51, 2021 - Issue 10
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Clinical Pharmacokinetics and Metabolism

In vitro study of the drug–drug interaction potential of cetagliptin and clinical study of pharmacokinetic interaction of cetagliptin and metformin in healthy volunteers

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Pages 1122-1131 | Received 08 Jul 2021, Accepted 28 Jul 2021, Published online: 11 Aug 2021

References

  • Baggio LL, Drucker DJ. 2007. Biology of incretins: GLP-1 and GIP. Gastroenterology. 132(6):2131–2157.
  • Bailey CJ. 1993. Metformin-an update. Gen Pharmacol. 24(6):1299–1309.
  • Cheung BM, Ong KL, Cherny SS, Sham PC, Tso AW, Lam KS. 2009. Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006. Am J Med. 122(5):443–453.
  • China Center for Drug Evaluation. 2012. Guideline for drug interaction research. http://www.cde.org.cn/zdyz.do?method=largePage&id=17f80cb05ff320e3.
  • Cook MN, Girman CJ, Stein PP, Alexander CM. 2007. Initial monotherapy with either metformin or sulphonylureas often fails to achieve or maintain current glycaemic goals in patients with type 2 diabetes in UK primary care. Diabet Med. 24(4):350–358.
  • Deacon CF, Ahren B, Holst JJ. 2004. Inhibitors of dipeptidyl peptidase IV: a novel approach for the prevention and treatment of Type 2 diabetes? Expert Opin Investig Drugs. 13(9):1091–1102.
  • Drucker DJ, Nauck MA. 2006. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 368(9548):1696–1705.
  • European Medicines Agency (EMA). 2012. Guideline on the investigation of drug interactions. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf.
  • Frank KB, Doshi M, Racha JK, Zhao S, Satoh H. 2002. Evaluation of HIV protease inhibitors for in vitro induction of drug metabolizing enzymes and stress genes in primary human hepatocytes. Drug Metab. Rev. 34(supplement 1):120.
  • Giacomini KM, Huang S-M, Tweedie DJ, Benet LZ, Brouwer KLR, Chu X, Dahlin A, Evers R, Fischer V, Hillgren KM, et al. 2010. Membrane transporters in drug development. Nat Rev Drug Discov. 9 (3):215–236.
  • Greuet J, Pichard L, Ourlin JC, Bonfils C, Domergue J, Le Treut P, Maurel P. 1997. Effect of cell density and epidermal growth factor on the inducible expression of CYP3A and CYP1A genes in human hepatocytes in primary culture. Hepatology. 25(5):1166–1175.
  • Hundal RS, Inzucchi SE. 2003. Metformin: new understandings, new uses. Drugs. 63(18):1879–1894.
  • Hutzler JM, Cook J, Fleishaker JC. 2011. Drug–drug interactions: designing development programs and appropriate product labeling. In: Bonate PL, Howard DR, editors. Pharmacokinetics in drug development. New York: Springer; p. 21–56.
  • Inzucchi SE, McGuire DK. 2008. New drugs for the treatment of diabetes: part II: Incretin-based therapy and beyond. Circulation. 117(4):574–584.
  • Kahn SE, Zraika S, Utzschneider KM, Hull RL. 2009. The beta cell lesion in type 2 diabetes: there has to be a primary functional abnormality. Diabetologia. 52(6):1003–1012.
  • Kocare TA, Schuetz Storm SC, Fisher FA, PS. Guzelian 1995. Comparative analysis of cytochrome P4503A induction in primary Culture of rat, rabbit and human hepatocytes. Drug Metab Disp. 32:415–421.
  • Lai Y, Sampson KE, Stevens JC. 2010. Evaluation of drug transporter interactions in drug discovery and development. Comb Chem High Throughput Screen. 13(2):112–134.
  • Lenhard JM, Croom DK, Minnick DT. 2004. Reduced serum dipeptidyl peptidase-IV after metformin and pioglitazone treatments. Biochem Biophys Res Commun. 324(1):92–97.
  • Li AP, Maurel P, Gomez-Lechon MJ, Cheng LC, Jurima- Romet M. 1997. Preclinical evaluation of drug–drug interaction potential: present status of the application of primary human hepatocytes in the evaluation of cytochrome P450 induction. Chem Biol Interact. 107(1–2):5–16.
  • Mannucci E, Tesi F, Bardini G. 2004. Effects of metformin on glucagon-like peptide-1 levels in obese patients with and without Type 2 diabetes. Diabetes Nutr Metab. 17:336–342.
  • MedDRA Maintenance and Support Services Organization. 2018. Medical dictionary for drug regulatory activities. version 21.1. Available at: https://admin.new.meddra.org/sites/default/files/guidance/file/intguide_21_1_english.pdf.
  • Mentlein R, Gallwitz B, Schmidt WE. 1993. Dipeptidyl-peptidase IV hydrolyses gastric inhibitory polypeptide, glucagon-like peptide-1(7-36)amide, peptide histidine methionine and is responsible for their degradation in human serum. Eur J Biochem. 214(3):829–835.
  • Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B, European Association for Study of Diabetes 2009. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 32(1):193–203.
  • Rodbard HW, Jellinger PS, Davidson JA, Einhorn D, Garber AJ, Grunberger G, Handelsman Y, Horton ES, Lebovitz H, Levy P, et al. 2009. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract. 15(6):540–559.
  • Russel FGM. 2010. Enzyme- and transporter-based drug–drug interactions: progress and future challenges. In: Pang KS, Rodrigues AD, Peter RM, editors. Transporters: importance in drug absorption, distribution, and removal. New York: Springer; p. 27–49.
  • Scheen AJ. 2014. Drug–drug interactions with sodium-glucose cotransporters type 2 (SGLT2) inhibitors, new oral glucose-lowering agents for the management of type 2 diabetes mellitus. Clin Pharmacokinet. 53(4):295–304.
  • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 2012. Guidance for industry, drug interaction studies-study. design, data analysis, implications for dosing, and labelling recommendations. Available at: https://www.xenotech.com/wp-content/uploads/2020/07/2012-FDA-DDI-Guidance.pdf.
  • US Food and Drug Administration. 2020. Guidance for industry. In vitro drug interaction studies -cytochrome P450 enzyme- and transporter mediated drug interactions; [accessed 2020 Oct 23]. https://www.fda.gov/media/134582/download.
  • Weber AE. 2004. Dipeptidyl peptidase IV inhibitors for the treatment of diabetes. J Med Chem. 47(17):4135–4141.
  • Yan Z, Caldwell GW. 2001. Metabolism profiling, and cytochrome P450 inhibition & induction in drug discovery. Curr Top Med Chem. 1(5):403–425.

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