Dose proportionality and the effect of food on vildaglipttn, a novel dipeptidyl peptidase IV inhibitor, in healthy volunteers

Journal of Clinical Pharmacology

Volumn 47, Issue 9, 2007, Pages 1152-1158

  Sunkara, Gangadhar ^c   Sabo, Ron ^c   Wang, Yibin ^c   He, Yan Ling ^a   Campestrini, Joelle ^c   Rosenberg, Mitchell ^b   Howard, Dan ^c   Dole, William P ^a  

^a NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^b Parkway Research Center Inc ^*  (United States)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Dose proportionality; Type 2 diabetes; Vharmacokinetics; Vildagliptin

Indexed keywords

DIPEPTIDYL PEPTIDASE IV; VILDAGLIPTIN;

ABSENCE OF SIDE EFFECTS; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIET RESTRICTION; DOSE TIME EFFECT RELATION; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG HALF LIFE; FEMALE; FOOD DRUG INTERACTION; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADAMANTANE; ADMINISTRATION, ORAL; ADULT; AREA UNDER CURVE; CONFIDENCE INTERVALS; CROSS-OVER STUDIES; DIETARY FATS; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOOD-DRUG INTERACTIONS; HALF-LIFE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MODELS, STATISTICAL; NITRILES; PYRROLIDINES;

EID: 37749048333     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007304313     Document Type: Article

References (14)

1. Holst JJ, Deacon CF. Inhibition of the activity of dipeptidylpeptidase IV as a treatment for type 2 diabetes. Diabetes. 1998; 47:1663-1670. (Pubitemid 28476238)
2. Mentlein R. Dipeptidyl-peptidase IV (CD26)-role in the inactivation of regulatory peptides. Regul Pept. 1999;85:9-24.
3. Kieffer TJ, Habener JF. The glucagon-like peptides. Endocrine Rev. 1999;20:876-913.
4. Drucker DJ. The biology of incretin hormones. Cell Metab. 2006;3:153-165.
5. Mari A, Sallas WM, He YL, et al. 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. (Pubitemid 41159387)
6. 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)
7. Matikainen N, Manttari S, Schweizer A, et al. Vildagliptin therapy reduces postprandial intestinal triglyceride-rich lipoprotein particles in patients with type 2 diabetes. Diabetologia. 2006;49: 2049-2057. (Pubitemid 44168471)
8. He YL, Sabo R, BaJez S, et al Absolute bioavailability of vildagliptin in healthy subjects. Clin Pharmacol Ther. 2006;79:P38.
9. He YL, Balch A, Campestrini J, et al. Pharmacokinetics and pharmacodynamics of the DPP-4 inhibitor, LAF237, in patients with type 2 diabetes. Clin Pharmacol Ther. 2005;77:P56.
10. Henness S, Keam SJ. Vildagliptin. Drugs. 2006;66:1989-2001.
11. Smith BP, Vandenhende FR, DeSante KA, et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res. 2000;17:1278-1283.
12. He YL, Barilla D, Ligueros-Saylan M, Riviere GJ, Campestrini J, Pratapa P. The pharmacokinetics and DPP-4 inhibition of LAF237 in healthy volunteers. J Clin Pharmacol. 2004;44:1212.
13. He YL, Sabo R, Picard F, et al. Lack of pharmacokinetic interaction between vildagliptin and metformin in patients with type 2 diabetes. Clin Pharmacol Ther. 2006;79:P62.
14. 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. (Pubitemid 41601073)