Abstract

Objective To assess the efficacy and safety of Supersession Prescription and metformin combination therapy in treatment of overweight and obese patients with T2DM. Methods This study was a 13-week, open-labeled, randomized parallel controlled study. Patients were randomly assigned to the treated and control groups in a 1:1 ratio. Both groups were provided metformin at the dosage of 750 mg twice daily as the primary treatment and the Supersession Prescription was given to the treated group as a supplementary treatment. Therapeutic outcomes were divided into three parts to assess different aspects of the whole effectiveness of the combination therapy and the primary outcome was body weight. Results A total of 80 subjects were recruited for this study and 74 finally completed. After 13 weeks of treatment, the levels of body weight, BMI, WC, WHR, HbA1C, FPG, 2hPG, HOMA-IR, TG, HDL, LDL and FFA were improved in the treated group (P < 0.05) and changes were significantly different in body weight, BMI, WL, HbA1C, FPG, 2hPG, LDL and FFA compared with the control group (P < 0.05). No serious adverse event including hypoglycemia was found in both of the two groups. Conclusions Supersession Prescription could produce a curative effect as a supplementary medical treatment combined with metformin and should be used while subjects could not achieve goals of weight or glucose management as well as were suffering from dyslipidemia.

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