Abstract
INTRODUCTION: The effect of dipeptidyl peptidase-4 (DDP-4) inhibitors versus α-glucosidase inhibitors (AGIs) on the treatment of type 2 diabetes mellitus (T2DM) in a real-world setting is unknown. The aim of this real-world study was to compare the glucose-lowering effect and tolerability of vildagliptin as add-on to metformin monotherapy (VM) and AGI as add-on to metformin monotherapy (AM) in Chinese patients with T2DM. METHODS: This was a subgroup analysis of the China Prospective Diabetes Study, a post-marketing, prospective, observational, real-world study conducted at 52 centers in China. T2DM patients with inadequate glycemic control on metformin monotherapy who received VM or AM were included. The composite primary endpoint was glycemic control (hemoglobin A1c [HbA1c] < 7%) after 12 months in the absence of tolerability events (hypoglycemia, weight gain ≥ 3%, or gastrointestinal events leading to treatment discontinuation). Propensity score matching (PSM) was used to balance the two groups. RESULTS: The success rates of the composite endpoint were higher in the VM group (n = 604/159 before/after PSM) than in the AM group (n = 159/157 before/after PSM), but the difference was not statistically significant (before PSM: 53.0 vs. 46.5%, P = 0.148; after PSM: 56.7 vs. 45.9%, P = 0.055). The glycemic control rate and HbA1c reduction were similar between groups at 3, 6, and 12 months. Compared with the AM group, the VM group had lower risks of any tolerability event (relative risk [RR] 0.53, 95% confidence interval [CI] 0.33-0.83, P = 0.006), of any adverse event (AE) (RR 0.64, 95% CI 0.41-1.00, P = 0.049), and of any serious AE (RR 0.45, 95% CI 0.25-0.81, P = 0.007). CONCLUSION: The results of this real-world study suggest that vildagliptin as add-on to metformin monotherapy had a similar glucose-lowering effect to AGI as add-on to metformin monotherapy, but with better safety.