Comparative Effectiveness and Safety of Acarbose and Vildagliptin in Type 2 Diabetes Management: A Real-World Observational Study in an Indian Population

Objective: To evaluate and compare the real-world effectiveness and safety profiles of acarbose and vildagliptin in patients with type 2 diabetes (T2D), with an additional focus on their impacts on the gut microbiota. Materials and methods: This was a real-world, observational, record-based study involving 98 patients with T2D, who were already on a stable regimen of metformin. Patients were divided into 2 groups: one receiving acarbose and the other vildagliptin, without any changes to their ongoing treatment with metformin and glimepiride. The primary outcomes measured were changes in HbA1c, fasting plasma glucose (FPG), and postprandial plasma glucose (PPPG) levels from baseline after 3 months of therapy. Secondary outcomes included the incidence of adverse drug reactions (ADRs) and specific gastrointestinal side effects. Results: The study included 48 patients on acarbose and 50 on vildagliptin, with comparable baseline characteristics. For effectiveness, the acarbose arm showed a decrease in HbA1c level by 1.0% while the vildagliptin arm showed a decrease of 0.9%. The acarbose arm showed a significant decrease of 47.6 mg/dL and 95.9 mg/dL, respectively, for FPG and PPPG at the end of 3 months, while the vildagliptin arm showed a decrease of 40.31 mg/dL for FPG and 79.5 mg/dL for PPPG (p < 0.001). The incidence of ADRs was comparable, although patterns of gastrointestinal side effects varied. Acarbose was associated with a higher incidence of flatulence and gastroparesis, whereas vildagliptin was linked to increased hyperacidity. Conclusions: Acarbose and vildagliptin both significantly improved glycemic control when added to metformin therapy. Despite the differences in safety profiles, both drugs were generally well tolerated.