Comparative Efficacy and Safety of Dual Versus Triple Lipid-Lowering Therapies (Rosuvastatin/Ezetimibe, Bempedoic Acid/Ezetimibe, and Rosuvastatin/Ezetimibe/Bempedoic Acid ) in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL
研究概览
简要总结
This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. The study aims to determine whether adding bempedoic acid to standard dual therapy provides superior lipid control without compromising safety. The 126 participants, aged 35 - 60 years will be randomly assigned to one of three treatment groups for 12 weeks, and their lipid profiles, glycemic control, and adverse effects will be monitored.The total duration of study will be 6 months, with a 3 months individual treatment period.
详细描述
This is a single-center, randomized, open-label clinical trial conducted over a 12-week period to evaluate the comparative efficacy and safety of dual versus triple lipid-lowering therapy in patients with type 2 diabetes mellitus (T2DM) and elevated LDL cholesterol (LDL-C).
The trial includes three treatment arms, Arm A will receive Rosuvastatin + Ezetimibe, Arm B will receive Bempedoic Acid + Ezetimibe and Arm C will receive Rosuvastatin + Ezetimibe + Bempedoic Acid.
Eligible participants are adults aged 35 - 60 years with a confirmed diagnosis of type 2 diabetes mellitus and elevated LDL cholesterol despite standard care. Exclude patients with severe hepatic or renal impairment, history of gout or hyperuricemia, muscle disorders or previous statin intolerance or Participation in another clinical trial within 30 days All participants will be randomly assigned to one of the three arms. Baseline assessments include lipid profile (TC, TG, HDL, LDL, VLDL), glycemic parameters (FBS, RBS, HbA1c), creatine kinase, uric acid, and documentation of medical history and concomitant medications. Follow-up assessments will occur at week 12 to evaluate changes in primary and secondary outcomes.
The primary outcome is change in LDL cholesterol from baseline to 12 weeks and secondary Outcomes include total cholesterol (TC), high-density lipoprotein (HDL), triglycerides (TG), very-low-density lipoprotein (VLDL), creatine kinase (CK), Uric acid, glycemic control like HbA1c, fasting blood sugar (FBS), random blood sugar (RBS), safety and tolerability including muscle spasm, myalgia, or gout attacks Safety Monitoring through all adverse events will be recorded during the study. If participants reporting muscle symptoms or hyperuricemia will be evaluated promptly. Laboratory tests will be repeated at study completion or earlier if clinically indicated.
This study is designed to assess whether the addition of bempedoic acid to standard dual therapy provides superior lipid-lowering efficacy without increasing adverse events in T2DM patients with elevated LDL-C. The findings will inform clinical practice on optimal lipid-lowering strategies for high-risk diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age 35-60 years
- •HbA1c ≥ 7.0 (≥ 48 mmol/mol)
- •On stable anti-diabetic therapy for at least 3 months
- •LDL-C > 100 mg/dL on at least two occasions
- •Diagnosed with hypercholesterolemia
- •Establish high cardiovascular risk (e.g, previous MI, stroke or atherosclerosis) or
- •≥2 cardiovascular risk factors (hypertension, smoking, obesity, family history)
- •BMI >23 - <32(WHO Asian Criteria)
- •No prior statin side effects
排除标准
- •HbA1c >10 % (86 mmol/mol)
- •BMI > 32
- •Type 1 Diabetes, gestational diabetes
- •Pregnancy or lactation
- •Acute liver disease or ALT/AST levels > 3× the upper limit of normal
- •Renal failure (GFR < 30 mL/min)
- •Uncontrolled hypothyroidism or nephrotic syndrome
- •Recent cancer diagnosis (last 6 months)
- •Current use of other lipid-lowering agents (e.g., fibrates or PCSK9 inhibitors)
- •Known allergy to any component
- •Statin intolerance with severe adverse effects (e.g., rhabdomyolysis)
研究组 & 干预措施
Rosuvastatin + Ezetimibe + Bempedoic Acid
This triple therapy combines statin therapy with cholesterol absorption inhibition and ATP citrate lyase inhibition to optimize LDL reduction.
干预措施: Rosuvastatin + Ezetimibe + Bempedoic Acid (Drug)
Rosuvastatin + Ezetimibe
Rosuvastatin is a statin that lowers LDL cholesterol by inhibiting HMG-CoA reductase. Ezetimibe inhibits cholesterol absorption in the intestine.
干预措施: Rosuvastatin + Ezetimibe (Drug)
Bempedoic Acid + Ezetimibe
Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol. Ezetimibe inhibits diatery cholesterol absorption in the intestine
干预措施: Bempedoic Acid + Ezetimibe (Drug)
结局指标
主要结局
Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL
时间窗: 12 weeks
The study will measure the percent change in LDL-C from baseline to 12 weeks and the proportion of participants achieving LDL-C \<70 mg/dL as per international guidelines.
Primary outcome: Percent reduction in LDL-C and proportion of patients achieving LDL-C <70 mg/dL
时间窗: 3 months
The study will measure the percentage change in LDL-C from baseline to 12 weeks and the proportion of participants achieving LDL-C \<70 mg/dL as per international guidelines to assess the efficacy of dual and triple lipid-lowering therapies in patients with Type 2 Diabetes Mellitus.
次要结局
- Secondary outcome : Change in Total Cholesterol Level From Baseline to 12 Weeks (mg/dL)(12 weeks)
- Secondary Outcome : Change in Triglyceride Level From Baseline to 12 Weeks (mg/dL)(12 weeks)
- Secondary Outcome : Change in HDL-C Level From Baseline to 12 Weeks (mg/dL)(12 weeks)
- Secondary Outcome : Change in VLDL Level From Baseline to 12 Weeks (mg/dL)(12 weeks)
- Secondary Outcome (Safety - Muscle Marker): Change in Creatine Kinase (CK) Level From Baseline to 12 Weeks (U/L)(12 weeks)
- Secondary Outcome (Safety - Metabolic Marker): Change in Uric Acid Level From Baseline to 12 Weeks (mg/dL)(12 weeks)
- Secondary Outcome (Adverse Events): Number of Participants Experiencing Treatment-Related Adverse Effects(12 weeks)
- Secondary outcome: Changes in Lipid Profile(3 months)
- Secondary Outcome: Safety Monitoring by muscle and metabolic Parameters(3 months)
- Secondary Outcome : Treatment-Related Adverse Effects(3 months)
研究者
Dr.Fatima khatoon
MPhil Candidate
Bahria University