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

This 24-week double-blind, randomized, multicenter, placebo-controlled, parallel-group study was performed in 632 drug-naive patients with type 2 diabetes to assess efficacy and tolerability of vildagliptin (50 mg qd, 50 mg bid, or 100 mg qd). HbA1c decreased modestly in patients receiving placebo (Delta = - 0.3 +/- 0.1 %) and to a significantly greater extent in patients receiving vildagliptin 50 mg qd (Delta = - 0.8 +/- 0.1 %), 50 mg bid (Delta = -0.8 +/- 0.1 %), or 100 mg qd (Delta = 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, HbA1c increased with placebo (Delta = +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 50 mg qd, 50 mg bid, and 100 mg 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 100 mg dose regimen (Delta = -1.3 +/- 0.2 % and -1.4 +/- 0.2 %) compared to 50 mg qd (Delta = -0.8 +/- 0.1 %). Body weight decreased modestly in all groups (by 0.3 to 1.8 kg). 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-naive patients without weight gain and is well tolerated with minimal hypoglycemia.