Objective To observe the effect of Kaiyu Qingre Formula（Formula for clearing stagnated heat） on improving the glucolipide metabolism of type Ⅱ diabetes mellitus（T2DM） patients with liver and stomach stagnated heat syndrome in TCM.Methods Totally 116 T2DM patients were treated with Kaiyu Qingre Formula.Glycosylated hemoglobin（HbA1c）

total cholesterol（TC）

triglyceride（TG）

low density lipoprotein cholesterol（LDL-C）

and high density lipoprotein cholesterol（HDL-C） before treatment and 3 months

6 months

18 months

and 2 years after treatment were observed respectively.Results After treatment

the level of HbA1c of all patients in different periods of time was significantly decreased（P<0.05 or P<0.01）.Except 6 months after treatment

the level of TC in other periods of time was significantly decreased than before treatment（P<0.05）.The level of LDL-C in the 6 months after treatment was significantly decreased than before treatment（P<0.05）

then it was increased again

but significantly decreased in the period of 2 years after treatment（P<0.01）.The levels of TC and HDL-C in all periods of time after treatment were without statistical difference in comparing with before treatment（P>0.05）.Conclusion Kaiyu Qingre Formula is effectively improving the glucolipide metabolism of T2DM patients with liver and stomach stagnated heat syndrome.It functions to regulate both glucometabolism and lipometabolism simultaneously.