Abstract: Objective To explore the effect of Gliclazide Sustained-release Tablets on the glucose and PAI-1 of patients with new-onset type 2 diabetes mellitus (NOT2DM).Methods Ninety patients with NOT2DM were randomly divided into two groups.Based on the treatment of proper exercise and dietary control,the control group orally took Metformin Tablets,while the treatment group took Gliclazide Sustained-release Tablets combined with Metformin Tablets.Both courses of treatment were 12 weeks.The changes of glucose and blood lipid-related indexes as well as adverse reactions were observed in both groups.Results After treatment,the levels of fasting plasma glucose (FPG),2 h postprandial glucose (2hPG)and glycosylated hemoglobin (HbA1c)in two groups went down obviously by comparison to treatment before,in which the decreased degrees in treatment group were more significant,with statistical significance.There was no statistical significance be-tween two groups regarding the levels of blood lipids before and after treatment,but PAI-1 level in treat-ment group after treatment was markedly lower than in control group.Conclusion For the patients with NOT2DM,Gliclazide Sustained-release Tablets combined with Metformin Tablets can significantly enhance the effect of decreasing glucose and lower PAI-1 level,with the efficacy superior to Metformin Tablets alone.