Titre du document / Document title

Vildagliptin in drug-naïve patients with type 2 diabetes : A 24-week, double-blind, randomized, placebo-controlled, multiple-dose study

Auteur(s) / Author(s)

DEJAGER S. ; RAZAC S. ; FOLEY J. E. ; SCHWEIZER A. ;

Résumé / Abstract

This 24-week double-blind, randomized, multicenter, placebo-controlled, parallel-group study was performed in 632 drug-naïve patients with type 2 diabetes to assess efficacy and tolerability of vildagliptin (50mg qd, 50mg bid, or 100mg qd). HbA1c decreased modestly in patients receiving placebo (Δ=-0.3 ±0.1%) and to a significantly greater extent in patients receiving vildagliptin 50mg qd (A= -0.8±0.1 %), 50 mg bid (Δ=-0.8±0.1%), or 100mg qd (Δ=-0.9±0.1 %, p<0.01 for all groups vs. placebo) from an average baseline of 8.4%. In patients diagnosed ≥3 months before enrollment, HbA1 c increased with placebo (Δ=+0.2±0.2%) and between-treatment differences (vildagliptin-placebo) were -0.8±0.2% (p<0.001), -0.7±0.2% (p=0.003), and -0.9±0.2% (p<0.001) with vildagliptin 50mg qd, 50mg bid, and 100mg qd, respectively. There was no apparent dose-response in the overall population; however, in patients with high baseline HbA1c, there were greater reductions with either 100mg dose regimen (A= -1.3±0.2% and -1.4±0.2%) compared to 50mg qd (Δ=-0.8±0.1 %). Body weight decreased modestly in all groups (by 0.3 to 1.8kg). The incidence of adverse events was similar across all groups and <1.2% of patients in any treatment group reported mild hypoglycemia. In conclusion, vildagliptin monotherapy decreases HbA1c in drug-naïve patients without weight gain and is well tolerated with minimal hypoglycemia.

Revue / Journal Title

Hormone and metabolic research   ISSN 0018-5043   CODEN HMMRA2 

Source / Source

2007, vol. 39, n^o3, pp. 218-223 [6 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

Thieme, Stuttgart, ALLEMAGNE  (1969) (Revue)

Mots-clés d'auteur / Author Keywords

• dipeptidyl peptidase-4 ; HbAlc ; GLP-1 . incretin hormones ;

Localisation / Location

INIST-CNRS, Cote INIST : 14356, 35400014715156.0090