Study Design
TG, T2DM, dyslipidemia
BLOOD, DYSLIPIDEMIA
This is an open-label, multicenter, prospective, randomized controlled study to evaluate the effects of xuezhikang (1.2 g/day) and pravastatin (20 mg/day) on TG levels and other blood lipid parameters for 6 weeks in patients with T2DM and dyslipidemia (study protocol version 4.0, dated 13 Jan 2021). Pravastatin is used as a comparator in this study as previous studies have shown that the magnitude of LDL-C reduction of pravastatin and xuezhikang at current dosages were similar [Patients with T2DM and dyslipidemia will be enrolled and randomly assigned (1:1) to xuezhikang or pravastatin therapy in 3 centers in China. Sealed envelopes with a red card or a white card, representing the experimental group (xuezhikang) and the control group (pravastatin), respectively, will be used to allocate the treatment arm. Blood lipids at fasting and 1, 2, and 4 h after a nutritious breakfast will be monitored at baseline and 6 weeks after treatment. Only drugs affecting lipid metabolism will be prohibited during the trial. Treatment will be discontinued because of withdrawal by patient for any reasons or decision by the investigator for safety reasons.