Evaluation of the pharmacokinetic interaction between the dipeptidyl peptidase IV inhibitor LC15-0444 and pioglitazone in healthy volunteers

International Journal of Clinical Pharmacology and Therapeutics

Volumn 50, Issue 1, 2012, Pages 17-23

  Kim, Sung Eun ^a   Yi, SoJeong ^a   Shin, Kwang Hee ^a   Kim, Tae Eun ^a   Kim, Min Jeong ^b   Kim, Youn Hoa ^b   Yoon, Seo Hyun ^a   Cho, Joo Youn ^a   Shin, Sang Goo ^a   Jang, In Jin ^a   Yu, Kyung Sang ^a  

^a Seoul National University College of Medicine   (South Korea)

^b LG Chemical Ltd   (South Korea)

Author keywords

Dipeptidyl peptidase IV inhibitor; Drug drug interaction; LC15 0444; Pharmacokinetics; Pioglitazone

Indexed keywords

DIPEPTIDYL PEPTIDASE IV INHIBITOR; LC 15 0444; PIOGLITAZONE; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HEADACHE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; METABOLITE; MONOTHERAPY; NORMAL HUMAN; OUTCOME ASSESSMENT; PROCESS DEVELOPMENT; PROCESS OPTIMIZATION; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; STEADY STATE; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; VALIDATION PROCESS;

ADULT; AREA UNDER CURVE; CROSS-OVER STUDIES; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG INTERACTIONS; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; ORGANIC CHEMICALS; THIAZOLIDINEDIONES; YOUNG ADULT;

EID: 84855177007     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201568     Document Type: Article

References (18)

1. ACTOS® [Label] Japan: Takeda Pharmaceuticals America, Inc.; 2008 Available at: http://www.accessdata. fda.gov/drugsatfda-docs/label/2008/ 021073s034lbl.pdf (accessed Feb 6, 2011)
2. Galvus® [European Public Assessment Reports (EPARs) Product Information] United Kingdom: Novartis Europharm Limited.;2010 Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Product-Information/ human/ 000771/WC500020327.pdf (accessed Feb 6, 2011).
3. World Medical Association. Declaration of Helsinki: Ethical principles for medical research involving human subjects. As amended by the 55th World Medical Assembly [WMA Web site] Available at: http://www.wma.net/en/ 30publications/10policies/ b3/index.html (accessed Feb 6, 2011).
4. Aronoff S, Rosenblatt S, Braithwaite S, Egan JW, Mathisen AL, Schneider RL. Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study. The Pioglitazone 001 Study Group. Diabetes Care. 2000; 23: 1605-1611. doi:10.2337/ diacare.23.11.1605 PubMed
5. Eckland DA, Danhof M. Clinical pharmacokinetics of pioglitazone. Exp Clin Endocr Diab. 2000; 108: 234-242. doi:10.1055/s-2000-8525
6. Graefe-Mody EU, Jungnik A, Ring A, Woerle HJ, Dugi KA. Evaluation of the pharmacokinetic interaction between the dipeptidyl peptidase-4 inhibitor linagliptin and pioglitazone in healthy volunteers. Int J Clin Pharmacol Ther. 2010; 48: 652-661. PubMed
7. Jaakkola T, Laitila J, Neuvonen PJ, Backman JT. Pioglitazone is metabolised by CYP2C8 and CYP3A4 in vitro: potential for interactions with CYP2C8 inhibitors. Basic Clin Pharmacol Toxicol. 2006; 99: 44-51. doi:10.1111/j.1742-7843.2006.pto-437.x PubMed (Pubitemid 44034394)
8. Karim A, Laurent A, Munsaka M, Wann E, Fleck P, Mekki Q. Coadministration of pioglitazone or glyburide and alogliptin: pharmacokinetic drug interaction assessment in healthy participants. J Clin Pharmacol. 2009; 49: 1210-1219. doi:10.1177/0091270009338938 PubMed
9. Lim KS, Cho JY, Kim BH, Kim JR, Kim HS, Kim DK, Kim SH, Yim HJ, Lee SH, Shin SG, Jang IJ, Yu KS. Pharmacokinetics and pharmacodynamics of LC15-0444, a novel dipeptidyl peptidase IV inhibitor, after multiple dosing in healthy volunteers. Br J Clin Pharmacol. 2009; 68: 883-890. doi:10.1111/j.1365-2125. 2009.03376.x PubMed
10. Lim KS, Kim JR, Choi YJ, Shin KH, Kim KP, Hong JH, Cho JY, Shin HS, Yu KS, Shin SG, Kwon OH, Hwang DM, Kim JA, Jang IJ. Pharmacokinetics, pharmacodynamics, and tolerability of the dipeptidyl peptidase IV inhibitor LC15-0444 in healthy Korean men: a dose-block-randomized, double-blind, placebo-controlled, ascending single- dose, Phase I study. Clin Ther. 2008; 30: 1817-1830. doi:10.1016/j.clinthera.2008.10.013 PubMed
11. Miyazaki Y, Matsuda M, DeFronzo RA. Dose-response effect of pioglitazone on insulin sensitivity and insulin secretion in type 2 diabetes. Diabetes Care. 2002; 25: 517-523. doi:10.2337/diacare. 25.3.517 PubMed
12. Pei Z. From the bench to the bedside: dipeptidyl peptidase IV inhibitors, a new class of oral antihyperglycemic agents. Curr Opin Drug Discov Devel. 2008; 11: 512-532. PubMed (Pubitemid 351950846)
13. Rhee EJ, Lee WY, Yoon KH, Yoo SJ, Lee IK, Baik SH, Kim YK, Lee MK, Park KS, Park JY, Cha BS, Lee HW, Min KW, Bae HY, Kim MJ, Kim JA, Kim DK, Kim SW. A multicenter, randomized, placebocontrolled, double-blind phase II trial evaluating the optimal dose, efficacy and safety of LC 15- 0444 in patients with type 2 diabetes. Diabetes Obes Metab. 2010; 12: 1113-1119. doi:10.1111/j.1463- 1326.2010.01303.x PubMed
14. Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006; 28: 1556-1568. doi:10.1016/j.clinthera. 2006.10.007 PubMed (Pubitemid 44841980)
15. Serra D, He YL, Bullock J, Riviere GJ, Balez S, Schwartz S, Wang Y, Ligueros-Saylan M, Jarugula V, Dole WP. Evaluation of pharmacokinetic and pharmacodynamic interaction between the dipeptidyl peptidase IV inhibitor vildagliptin, glyburide and pioglitazone in patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2008; 46: 349-364. PubMed (Pubitemid 352005928)
16. Triplitt C, Cersosimo E, DeFronzo RA. Pioglitazone and alogliptin combination therapy in type 2 diabetes: a pathophysiologically sound treatment. Vasc Health Risk Manag. 2010; 6: 671-690. PubMed
17. Vaidya HB, Goyal RK. Glucagon like peptides-1 modulators as newer target for diabetes. Curr Drug Targets. 2008; 9: 911-920. doi:10.2174/ 138945008785909284 PubMed
18. Yki-Järvinen H. Thiazolidinediones. N Engl J Med. 2004; 351: 1106-1118. doi:10.1056/NEJMra041001 PubMed