Post-Marketing Study of Vildagliptin in Japanese Patients with Type 2 Diabetes

A 52-week post-marketing surveillance study involving 3,006 Japanese patients with type 2 diabetes mellitus (T2DM) has confirmed that vildagliptin, when used in combination with various oral antidiabetic drugs (OADs) or insulin, is both safe and effective. The study reported adverse events (AEs) in 13.6% of patients and serious adverse events (SAEs) in 2.2%, with similar frequencies across different combination therapies.
Patients showed significant improvements in glycemic control, with mean reductions of 0.76% in HbA1c and 23.3 mg/dL in fasting blood glucose over 52 weeks. These results were consistent regardless of the accompanying OAD.
Originally approved in 2013, vildagliptin had limited combination data in Japanese patients, particularly with higher doses of metformin. This real-world study provides strong evidence supporting the long-term safety and efficacy of vildagliptin combination therapy in managing T2DM.