Objective: To investigate the effects of Metformin/Vildagliptin Tablets in the treatment of patients with Type 2 diabetes mellitus (T2DM) at high cardiovascular risk and protection of cardiac and renal functions. Methods: A total of 94 patients with high cardiovascular risk T2DM were selected as study subjects. According to the different therapeutic drugs, they were divided into the fixed-dose combination (FDC) group (Metformin/Vildagliptin Tablets, n=42) and the metformin group (metformin alone, n=52). Both groups were treated for 6 months. The blood glucose control status [fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPG), and glycated hemoglobin (HbA1c) levels], pancreatic β-cell function [fasting insulin (FINS) levels, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β)], cardiac function [stroke volume (SV), left ventricular end diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF)], renal function [urinary microalbumin and creatinine levels, urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR)] were compared between the two groups. Results: After treatment, the levels of FBG, 2hPG, and HbA1c, and HOMA-IR, LVEDD, and UACR in the FDC group were lower than those in the metformin group (P<0.05). After treatment, the FINS levels and eGFR in the FDC group were higher than those in the metformin group (P <0.05). Conclusion: For T2DM patients with high cardiovascular risk, the Metformin/Vildagliptin fixed-dose combination is superior to metformin monotherapy in terms of glycemic control, improvement of pancreatic islet function, and cardiac and renal protection.