Efficacy and tolerability of vildagliptin in drug-naïve patients with type 2 diabetes (T2DM) and mild hyperglycemia

Abstract

Vildagliptin is a potent and selective DPP-4 inhibitor that improves glycemic control in patients with T2DM by increasing both α- and β-cell responsiveness to glucose. In earlier studies enrolling patients with T2DM and baseline A1C of 7.5 to 11%, vildagliptin 100mg daily was very well-tolerated and decreased mean A1C by 1% or more. However, despite current trends toward earlier and more aggressive intervention, patients with T2DM and only mild hyperglycemia are not well-studied. This 52-week, randomized study examined efficacy and tolerability of vildagliptin 50mg qd (n=156) vs. placebo (n=150) in patients with T2DM and mild hyperglycemia (A1C of 6.2 to 7.5%). All patients received lifestyle counseling at every visit. Standard meal tests were performed at baseline and endpoint and insulin secretion relative to glucose (ISR AUC0–2h/glucose AUC0–2h) was calculated as an index of β-cell function. At baseline mean age=63.1y (47% aged ≥65y), BMI=30.2kg/m², FPG=7.1 mM and A1C=6.7%. Relative to placebo, vildagliptin significantly increased β-cell function (5.0±1.2pmol/min/m²/mM, PConclusion: in drug-naïve patients with T2DM and mild hyperglycemia, vildagliptin 50mg qd is well-tolerated and decreases A1C primarily by improving β-cell function and decreasing postprandial glucose.