Aim: This study was conducted to assess efficacy and tolerability of vildagliptin in drug-naïve 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-naïve 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 (Δ = −0.2 ± 0.1%) and increased in patients receiving placebo (Δ = 0.1 ± 0.1%). The between-group difference (vildagliptin − placebo) in adjusted mean change (AMΔ) in A1C was −0.3 ± 0.1% (p < 0.001). FPG increased in patients receiving placebo (Δ = 0.5 ± 0.1 mmol/l) and to a significantly lesser extent in vildagliptin-treated patients (between-group difference in AMΔ 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 AUC0–2 h] increased (+5.0 ± 1.2 pmol/min/m2/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-naïve 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.