Objective:To explore the effect of irbesartan in the treatment of the patients with hypertension complicated with diabetes mellitus and its influence on urine trace albumin. Methods:Totally 62 cases of patients with hypertension complicated with diabetes mel-litus were divided into the observation group and the control group randomly with 31 patients in each. The patients in the control group were given the conventional blood sugar and blood pressure control, and the patients in the observation group were treated with irbesartan additionally. The treatment course was 3 months. The changes of blood pressure and urine trace albumin of the patients in the two groups before and after the treatment were compared, and the effect of blood pressure control and the adverse effects were evaluated as well. Re-sults:The total effective rate of the observation group was 96. 8%, which was much higher than that of the control group (83. 9%, P<0. 05) , and the difference had statistical significance (P<0. 05). After the treatment, the systolic blood pressure and diastolic blood pressure of the patients in the two groups were reduced significantly (P<0. 05), and the urinary albumin excretion rate (UAER) and the level of urine trace albumin (mAlb) of the patients in the two groups were obviously lowered (P<0. 05), and the decrease in the obser-vation group was more notable than that in the control group (P<0. 05). No significant difference in the incidence of adverse reactions was shown between the two groups(P>0. 05). Conclusion:The clinical effect of irbesartan in the treatment of patients with hypertension complicated with diabetes mellitus is promising with low incidence of adverse effects,which can effectively protect renal function as well.