Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus.

INTRODUCTION

The objective of this study was to evaluate the efficacy and safety of vildagliptin, a potent dipeptidyl peptidase-4 inhibitor, as an add-on to metformin in Japanese patients with type 2 diabetes mellitus (T2DM).

METHODS

This multicenter, 12-week, randomized, double-blind, placebo-controlled, parallel-arm study compared vildagliptin 50 mg bid with placebo in T2DM patients who were inadequately controlled [glycosylated hemoglobin (HbA1c) 7.0-10.0%] on a stable daily dose of metformin monotherapy (250 mg bid or 500 mg bid).

RESULTS

A total of 139 patients were randomized to receive either vildagliptin (n = 69) or placebo (n = 70). Patient demographics were comparable between the groups at baseline. After 12 weeks of treatment, adjusted mean change in HbA1c was -1.1% in the vildagliptin group (baseline 8.0%) and -0.1% in the placebo group (baseline 8.0%), with a between-treatment difference of -1.0% (P < 0.001). Vildagliptin showed a similar reduction in HbA1c of -1.1% for both the subpopulations of patients receiving metformin 250 mg bid or 500 mg bid (P < 0.001 vs. baseline). Significantly more patients in the vildagliptin group achieved an HbA1c target of ≤6.5% (30.9%) and <7.0% (64.1%) compared with the placebo group (P < 0.001). The between-treatment difference in adjusted mean change in fasting plasma glucose was -1.6 mmol/L (P < 0.001) in favor of vildagliptin. Patients in the vildagliptin and placebo groups reported comparable incidences of adverse events (44.1% vs. 41.4%). No deaths or hypoglycemic events were reported in the study.

CONCLUSIONS

Vildagliptin 50 mg bid added to metformin improved glycemic control without any tolerability issues and hypoglycemia in Japanese patients with T2DM inadequately controlled on metformin monotherapy.