Evaluating Long-Term Safety and Effectiveness of Ezefeno Tablets Combined with Moderate-Intensity Statins in Adults with Type 2 Diabetes and Dyslipidemia Not Controlled by Statins Alone

What this Trial Is About

Researchers are evaluating the long-term efficacy and safety of a combined therapy using Ezefeno tablets in patients who have dyslipidemia and type 2 diabetes mellitus T2DM. The study focuses on patients who do not achieve adequate control of non-HDL cholesterol levels despite moderate-intensity statin treatment. This randomized, open-label, multicenter trial aims to assess major adverse cardiovascular events and diabetic microvascular events over 48 months. Participants will be randomly assigned to one of two groups a treatment group receiving a combination of ezetimibefenofibrate Ezefeno with moderate-intensity statins, or a control group undergoing dose escalation of moderate-intensity statins alone. The trial will last for 48 months, during which the effects of these treatment strategies on cholesterol levels and cardiovascular outcomes will be monitored. During the study, participants will undergo regular assessments to measure major cardiovascular and microvascular events. Researchers will also track changes in lipid profiles, including non-HDL cholesterol, LDL, HDL-C, triglycerides, and cholesterol ratios. Safety and adherence will be monitored throughout the trial duration. The study spans from baseline through 48 months, with ongoing monitoring to evaluate both efficacy and safety outcomes.

To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM