| Objective: To explore the efficacy and safety of Xiaoke Pill combined with dapagliflozin in the treatment of type 2 diabetes mellituswith metabolic syndrome.
Methods: Sixty patients with type 2 diabetes mellitus complicated with metabolic syndrome in Shaowu Municiple Hospital of Fujian Province were randomly divided into Xiaoke pill group and control group. The control group was given dapagliflozin orally. The Xiaoke pill group was given Xiaoke pill on the basis of the control group. The course of treatment was 12 weeks. The main outcome measures included fasting blood glucose (FPG), two-hour postmeal blood glucose (2h PG), glycated hemoglobin (HbA1c), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), and blood pressure. Adverse reactions were observed during the study.
Results: Compared to the control group，the treatment of Xiaoke Pill significantly decreased the level of FPG on 4, 8 and 12 weeks (all P < 0.05). There was no significant difference between the two groups in 2hPG and HbAlc (all P > 0.05). Compared to the control group，the intervention of Xiaoke Pill significantly reduced the level of TC on 8 and 12 weeks (all P < 0.05). There was no significant difference between the two groups in TG, HDL-C and LDL-C (all P > 0.05). The systolic blood pressure in Xiaoke pill group was significantly lower than that in control group with treatment of 12 weeks (P < 0.05). There was no significant difference in systolic blood pressure between the two groups (all P > 0.05). No adverse reactions were reported in both groups.
Conclusion: Xiaoke Pill combined with Daglipzin treated type 2 diabetes mellitus with metabolic syndrome with good efficacy and safety. |