Pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes

International Journal of Clinical Pharmacology and Therapeutics

Volumn 48, Issue 9, 2010, Pages 582-595

  He, Y L ^a   Yamaguchi, M ^b   Ito, H ^b   Terao, S ^b   Sekiguchi, K ^b  

^a NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^b NOVARTIS PHARMA K K   (Japan)

Author keywords

DPP 4; GLP 1; Japanese; Pharmacokinetics; Vildagliptin

Indexed keywords

DIPEPTIDYL PEPTIDASE IV; GLUCAGON; GLUCAGON LIKE PEPTIDE 1; GLUCOSE; INSULIN; PLACEBO; VILDAGLIPTIN; ADAMANTANE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; NITRILE; PYRROLIDINE DERIVATIVE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG ELIMINATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; ECZEMA; ELECTROCARDIOGRAPHY; ENZYME ACTIVITY; ENZYME INHIBITION; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN BLOOD LEVEL; JAPANESE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NON INSULIN DEPENDENT DIABETES MELLITUS; OCCULT BLOOD TEST; POSTPRANDIAL STATE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; VITAL SIGN; ANALOGS AND DERIVATIVES; BLOOD; DIABETES MELLITUS, TYPE 2; MIDDLE AGED;

ADAMANTANE; ADULT; AGED; AREA UNDER CURVE; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOUBLE-BLIND METHOD; FEMALE; GLUCAGON; GLUCAGON-LIKE PEPTIDE 1; HUMANS; INSULIN; MALE; MIDDLE AGED; NITRILES; PYRROLIDINES;

EID: 77956928415     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/cpp48582     Document Type: Article

References (36)

1. Ahren B, Gomis R, Standl E, Mills D, Schweizer A. Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformintreated patients with Type 2 diabetes. Diabetes Care. 2004; 27: 2874-2880. (Pubitemid 39565052)
2. Ahren B, Landin-Olsson M, Jansson PA, Svensson M, Holmes D, Schweizer A. Inhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels, and reduces glucagon levels in Type 2 diabetes. J Clin Endocrinol Metab. 2004; 89: 2078-2084. (Pubitemid 38619835)
3. Ahren B, Schweizer A, Dejager S, Dunning BE, Nilsson PM, Persson M, Foley JE. Vildagliptin enhances islet responsiveness to both hyper- and hypoglycemia in patients with Type 2 diabetes. J Clin Endocrinol Metab. 2009; 94: 1236-1243.
4. Azuma K, Radikova Z, Mancino J, Toledo FG, Thomas E, Kangani C, Dalla Man C, Cobelli C, Holst JJ, Deacon CF, He Y, Ligueros-Saylan M, Serra D, Foley JE, Kelley DE. Measurements of islet function and glucose metabolism with the dipeptidyl peptidase 4 inhibitor vildagliptin in patients with Type 2 diabetes. J Clin Endocrinol Metab. 2008; 93: 459-464.
5. Bonadonna RC, Stumvoll M, Fritsche A, Muggeo M, Haring H, Bonora E, van Haeften TW. Altered homeostatic adaptation of first- and second-phase beta-cell secretion in the offspring of patients with Type 2 diabetes: studies with aminimalmodel to assess beta-cell function. Diabetes. 2003; 52: 470-480. (Pubitemid 36173205)
6. D'Alessio DA, Denney AM, Hermiller LM, Prigeon RL, Martin JM, Tharp WG, Saylan ML, He Y, Dunning BE, Foley JE, Pratley RE. Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with Type 2 diabetes. J Clin Endocrinol Metab. 2009; 94: 81-88.
7. Fukushima M, Usami M, Ikeda M, Nakai Y, Taniguchi A, Matsuura T, Suzuki H, Kurose T, Yamada Y, Seino Y. Insulin secretion and insulin sensitivity at different stages of glucose tolerance: a cross-sectional study of Japanese Type 2 diabetes. Metabolism. 2004; 53: 831-835.
8. Garber AJ, Sharma MD. Update: vildagliptin for the treatment of Type 2 diabetes. Expert Opin Investig Drugs. 2008; 17: 105-113. (Pubitemid 351578215)
9. He YL, Barilla D, Ligueros-Saylan M, Rivere G-J, Campestrini J, Pratapa P. The pharmacokinetics and DPP-4 inhibition of LAF237 in healthy volunteers. J Clin Pharmacol. 2004; 44: 1212.
10. He YL, Ligueros-Saylan M, Sunkara G, Sabo R, Zhao C, Wang Y, Campestrini J, Pommier F, Dole K, Marion A, Dole WP, Howard D. Vildagliptin, a novel dipeptidyl peptidase IV inhibitor, has no pharmacokinetic interactions with the antihypertensive agents amlodipine, valsartan, and ramipril in healthy subjects. JClin Pharmacol. 2008; 48: 85-95.
11. He YL, Sadler BM, Sabo R, Balez S, Wang Y, Campestrini J, Laurent A, Ligueros-Saylan M, Howard D. The absolute oral bioavailability and population-based pharmacokinetic modelling of a novel dipeptidylpeptidase-IV inhibitor, vildagliptin, in healthy volunteers. Clin Pharmacokinet. 2007; 46: 787-802.
12. He YL, Serra D, Wang Y, Campestrini J, Riviere GJ, Deacon CF, Holst JJ, Schwartz S, Nielsen JC, Ligueros-Saylan M. Pharmacokinetics and pharmacodynamics of vildagliptin in patients with Type 2 diabetes mellitus. Clin Pharmacokinet. 2007; 46: 577-588. (Pubitemid 47025358)
13. He YL, Wang Y, Bullock JM, Deacon CF, Holst JJ, Dunning BE, Ligueros-Saylan M, Foley JE. Pharmacodynamics of vildagliptin in patients with Type 2 diabetes during OGTT. J Clin Pharmacol. 2007; 47: 633-641. (Pubitemid 46632151)
14. Herman GA, Stevens C, Van Dyck K, Bergman A, Yi B, De Smet M, Snyder K, Hilliard D, Tanen M, Tanaka W, Wang AQ, Zeng W, Musson D, Winchell G, Davies MJ, Ramael S, Gottesdiener KM, Wagner JA. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther. 2005; 78: 675-688.
15. Hirose T, Kawamori R. Diabetes in Japan. Curr Diab Rep. 2005; 5: 226-229.
16. Holst JJ, Deacon CF. Inhibition of the activity of dipeptidyl-peptidase IV as a treatment for Type 2 diabetes. Diabetes. 1998; 47: 1663-1670. (Pubitemid 28476238)
17. Hu P, Yin Q, Deckert F, Jiang J, Liu D, Kjems L, Dole WP, He YL. Pharmacokinetics and pharmacodynamics of vildagliptin in healthy Chinese volunteers. J Clin Pharmacol. 2009; 49: 39-49.
18. Katsuya T. Report of the Committee of Japan Diabetes Society on the classification and diagnostic criteria of diabetes mellitus. J Japan Diab Soc. 1999; 42: 385-401.
19. Kawamori R. Diabetes trends in Japan. Diabetes Metab Res Rev. 2002; 18 (Suppl): 9-13.
20. Kieffer TJ, Habener JF. The glucagon-like peptides. Endocr Rev. 1999; 20: 876-913.
21. Kim D, Wang L, Beconi M, Eiermann GJ, Fisher MH, He H, Hickey GJ, Kowalchick JE, Leiting B, Lyons K, Marsilio F, McCann ME, Patel RA, Petrov A, Scapin G, Patel SB, Roy RS, Wu JK, Wyvratt MJ, Zhang BB, Zhu L, Thornberry NA, Weber AE. (2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro [1,2,4]triazolo[4,3-a] pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine: a potent, orally active dipeptidyl peptidase IV inhibitor for the treatment of Type 2 diabetes. J Med Chem. 2005; 48: 141-151.
22. Lauster CD, McKaveney TP, Muench SV. Vildagliptin: a novel oral therapy for Type 2 diabetes mellitus. Am J Health Syst Pharm. 2007; 64: 1265-1273. (Pubitemid 47216194)
23. Mari A, Sallas WM, He YL, Watson C, Ligueros-Saylan M, Dunning BE, Deacon CF, Holst JJ, Foley JE. Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with Type 2 diabetes. J Clin Endocrinol Metab. 2005; 90: 4888-4894.
24. Mari A, Schmitz O, Gastaldelli A, Oestergaard T, Nyholm B, Ferrannini E. Meal and oral glucose tests for assessment of beta -cell function: modeling analysis in normal subjects. Am J Physiol Endocrinol Metab. 2002; 283: 1159-1166.
25. Nakanishi S, Okubo M, Yoneda M, Jitsuiki K, Yamane K, Kohno N. Acomparison between Japanese- Americans living in Hawaii and Los Angeles and native Japanese: the impact of lifestyle west-ernization on diabetes mellitus. Biomed Pharmacother. 2004; 58: 571-577. (Pubitemid 40260379)
26. Ohneda A, Watanabe K, Horigome K, Sakai T, Kai Y, Oikawa S. Abnormal response of pancreatic glucagon to glycemic changes in diabetes mellitus. J Clin Endocrinol Metab. 1978; 46: 504-510. (Pubitemid 8305068)
27. Pi-Sunyer FX, Schweizer A, Mills D, Dejager S. Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with Type 2 diabetes. Diabetes Res Clin Pract. 2007; 76: 132-138. (Pubitemid 46240373)
28. Pratley RE, Jauffret-Kamel S, Galbreath E, Holmes D. Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with Type 2 diabetes. Horm Metab Res. 2006; 38: 423-428. (Pubitemid 44047965)
29. Pratley RE, Salsali A. Inhibition of DPP-4: a new therapeutic approach for the treatment of Type 2 diabetes. Curr Med Res Opin. 2007; 23: 919-931.
30. Pratley RE, Salsali A, Matfin G. Inhibition of dipeptidyl peptidase-4 with vildagliptin: a potential new treatment for Type 2 diabetes. Br J Diabetes Vasc Dis. 2006; 6: 150-156.
31. Ristic S, Byiers S, Foley J, Holmes D. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with Type 2 diabetes: vildagliptin (LAF237) dose response. Diabetes Obes Metab. 2005; 7: 692-698.
32. Rosenstock J, Foley JE, Rendell M, Landin-Olsson M, Holst JJ, Deacon CF, Rochotte E, Baron MA. Effects of the dipeptidyl peptidase-IV inhibitor vildagliptin on incretin hormones, islet function, and postprandial glycemia in subjects with impaired glucose tolerance. Diabetes Care. 2008; 31: 30-35.
33. Seidell JC. Obesity, insulin resistance and diabetes - a worldwide epidemic. Br J Nutr. 2000; 83 (Suppl): 5-8.
34. Serra D, He YL, Bullock J, Riviere GJ, Balez S, Schwartz S, Wang Y, Ligueros-Saylan M, Jarugular V, Dole WP. Evaluation of pharmacokinetic and pharmacodynamic interaction between the dipeptidyl peptidase IV inhibitor vildagliptin in combination with glyburide or pioglitazone in patients with Type 2 diabetes. Int J Clin Pharmacol Ther. 2008; 46: 349-364.
35. Sunkara G, Sabo R, Wang Y, He YL, Campestrini J, Howard D, Dole WP. Dose proportionality and the effect of food on vildagliptin, a novel dipeptidyl peptidase IV inhibitor, in healthy volunteers. J Clin Pharmacol. 2007; 47: 1152-1158.
36. Xie HG, Kim RB, Wood AJ, Stein CM. Molecular basis of ethnic differences in drug disposition and response. Annu Rev Pharmacol Toxicol. 2001; 41: 815-850.