Objective To summarize the available clinical research evidence on gliquidone for treating diabetes mellitus. Methods The clinical research on gliquidone for diabetes mellitus was systematically searched and appraised. Result Six randomized controlled trials and eleven controlled clinical trials were identified. The methodological quality of most papers about gliquidone for diabetes mellitus was poor. Currently, clinically patient-related endpoints as outcome measures and health economic analyses are lacking in this field. Conclusions Based on the available evidence, gliquidone appears specifically applicable to elderly diabetic patients with kidney diseases. More methodologically sound and patient-related endpoints and economic analyses based on clinical research are required.