PUMA
Istituto di Ingegneria Biomedica     
Scherbaum W., Schweizer A., Nilsson P., Lalanne G., Jauffret S., Foley J. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia. In: Diabetes Obesity & Metabolism, vol. 10 (8) pp. 675 - 82. Wiley, 2008.
 
 
Abstract
(English)
Aim: This study was conducted to assess efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia. Methods: Multicentre, double-blind, randomized, placebo-controlled, parallel-group study of 52-week treatment with vildagliptin (50 mg q.d.) in 306 drug-naive patients with type 2 diabetes (A1C = 6.2-7.5%). A1C, fasting plasma glucose (FPG) and measures of prandial glucose control and beta-cell function determined during standard meal tests were assessed. Results: Baseline A1C and FPG averaged 6.7% and 7.1 mmol/l, respectively, in patients randomized to vildagliptin (n = 156) and 6.8% and 7.2 mmol/l in those randomized to placebo (n = 150). A1C decreased modestly in vildagliptin-treated patients (Delta = -0.2 +/- 0.1%) and increased in patients receiving placebo (Delta = 0.1 +/- 0.1%). The between-group difference (vildagliptin - placebo) in adjusted mean change (AMDelta) in A1C was -0.3 +/- 0.1% (p < 0.001). FPG increased in patients receiving placebo (Delta = 0.5 +/- 0.1 mmol/l) and to a significantly lesser extent in vildagliptin-treated patients (between-group difference in AMDelta FPG = -0.4 +/- 0.2 mmol/l, p = 0.032). Relative to placebo, 2-h postprandial glucose (PPG) decreased (-0.9 +/- 0.4 mmol/l, p = 0.012), and insulin secretory rate (ISR) relative to glucose [ISR area under the curve (AUC)(0-2) (h)/glucose AUC(0-2) (h)] increased (+5.0 +/- 1.2 pmol/min/m(2)/mM, p < 0.001). Mean body weight decreased by 0.5 +/- 0.3 kg in vildagliptin-treated patients and by 0.2 +/- 0.3 kg in patients receiving placebo. The side-effect profile of vildagliptin was similar to that of placebo, and one hypoglycaemic episode occurred in one patient receiving placebo. Conclusions: In drug-naive patients with mild hyperglycaemia, relative to placebo, 52-week treatment with vildagliptin 50 mg q.d. significantly decreases A1C, FPG and PPG and improves beta-cell function without weight gain or hypoglycaemia.
URL: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18248490
DOI: 10.1111/j.1463-1326.2008.00850.x
Subject A1C
dipeptidyl peptidase-4
GLP-1
incretin hormones


Icona documento 1) Download Document PDF


Icona documento Open access Icona documento Restricted Icona documento Private

 


Per ulteriori informazioni, contattare: Librarian http://puma.isti.cnr.it

Valid HTML 4.0 Transitional