Abstract：Objective：To observe the clinical effect of Wenyang Yiqi Huoxue Decoction combined with routine western medicine for type 2 diabetes mellitus complicated with renal insufficiency. Methods：A total of 90 cases of patients with type 2 diabetes mellitus complicated with renal insufficiency were selected and divided into the control group and the study group according to the random number table method， with 45 cases in each group. The control group was treated with routine western medicine，and the study group was additionally treated with Wenyang Yiqi Huoxue Decoction based on the treatment of the control group. The changes of serum indexes， kidney function indexes， traditional Chinese medicine (TCM) syndrome scores and blood glucose indexes were compared between the two groups，and the clinical effects in the two groups were evaluated. Results：The total effective rate was 95.56% in the study group，higher than that of 82.22% in the control group，the difference being significant (P＜0.05). After treatment，the levels of soluble vascular cell adhesion molecule (sVCAM-1) and microRNA-16 (miR-16) in the two groups were decreased when compared with those before treatment (P＜0.05)，and the levels of sVCAM- 1 and miR- 16 in the study group were lower than those in the control group (P＜0.05). After treatment，the levels of blood urea nitrogen (BUN)， serum creatinine (SCr) and urinary albumin excretion rate (UAER) in the two groups were decreased when compared with those before treatment (P＜0.05)， and the levels of BUN， SCr and UAER in the study group were lower than those in the control group (P＜0.05). After treatment， TCM syndrome scores in the two groups were decreased when compared with those before treatment (P＜ 0.05)，and the score in the study group was lower than that in the control group (P＜0.05). After treatment， the levels of fasting blood glucose (FBG)， 2- hour postprandial blood glucose (P2hBG) and glycosylated hemoglobin (HbA1c) in the two groups were decreased when compared with those before treatment (P＜ 0.05)，and the levels of FBG，P2hBG and HbA1c in the study group were lower than those in the control group (P＜0.05). Conclusion：Wenyang Yiqi Huoxue Decoction has a good clinical effect in the treatment of type 2 diabetes mellitus complicated with renal insufficiency， which can effectively reduce the levels of sVCAM-1 and miR-16 in serum and blood glucose，and improve the kidney function.