NCT04700436已完成4 期
A Multi-center, Randomized, Open-label, Active-controlled, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of EzetimiBe/Rosuvastatin Diabetic Dislipidemia With Hypertriglyceridaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 26
- 主要终点
- Triglyceride (TG) change rate (percent, %)
研究概览
简要总结
To compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).
详细描述
The purpose of this study is to compare and evaluate the effects of LDL-C and Triglyceride (TG) control on the first dose Ezetimibe/Statin (Rosuvastatin 5 mg/Ezetimibe 10 mg) combination therapy compared to the average dose Statin (Rosuvastatin 10 mg) monotherapy in patients with Type 2 diabetes with hypertriglyceridemia (TG > 200 mg/dL).
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening (Visit 1) Inclusion Criteria
- •Korean men and women aged 40 to 75
- •Patients who have been diagnosed with type 2 diabetes based on clinical judgment and satisfy diabetes diagnosis criteria
- •Who have the following laboratory values on an empty stomach
- •Patients with no prior statin therapy
- •Low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are < 400 mg/dL)
- •200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
- •Patients currently receiving low- or moderate-intensity statin therapy
- •Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (measured directly or calculated; calculated LDL-C is applicable only when triglyceride levels are < 400 mg/dL)
- •200 mg/dL ≤ Triglyceride (TG) ≤ 499 mg/dL
- •Those with less than 9% HbA1C
- •Those who voluntarily agreed to participate in this clinical trial and signed a written ICF
- •Randomization (Visit 2) Inclusion Criteria
- •Persons with compliance 80% or more during Suvast tablet 5 mg Run-in period and with good TLC by investigator's judgment
排除标准
- •Patients with hypersensitivity to the main ingredient (Ezetimibe or Rosuvastatin) and ingredients of IP
- •Pregnant and lactating women, and women and men of childbearing potential who do not agree to conduct appropriate contraception during clinical trial
- •Patients with Body Mass Index (BMI) < 15 kg/ m2 or > 35 kg/m2
- •Persons with the following medical history or surgical/interventional history
- •Atherosclerotic disease occurring within 24 weeks at screening
- •Myopathy including rhabdomyolysis
- •Patients who have had a history of drug or alcohol abuse, or who have met drug or alcohol abuse criteria within 1 year at screening
- •Major mental illness (depression, bipolar disorder, etc.)
- •Malignant tumor within 5 years at screening
- •Persons with the following comorbidities and laboratory abnormalities
- •CK ≥ 2 X ULN
- •Patients with severe hepatopathy (AST or ALT > 5 X ULN)
- •Patients with unexplained persistent ALT elevation opinion or active liver disease
- •TSH (Thyroid stimulating hormone) > 1.5 X ULN or those who do not maintain stable thyroid stimulating hormone level by investigator's judgment
- •Uncontrolled hypertension (greater than sitBP 160/100 mmHg at screening)
- •Renal disorder patients with severe renal failure (creatinine clearance (CLcr)<30 mL/min
- •Those who have the following history of drug administration within 3 months at screening
- •Non-statin lipid modulators
- •Foods or drugs that affect lipid control
- •Systemic steroids
- •Those who are expected to administer contraindication drugs during clinical trial, including screening
- •Those who have persistent history of drinking within 1 week at clinical trial participation or who are unable to perform TLC due to continuous drinking during clinical trial
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorptioin
- •Those who received other IPs or investigational medical devices within 30 days at screening
- •Patients judged to be ineligible to participate in clinical trial by investigator's decision
研究组 & 干预措施
Test group
Experimental
Subject administered with Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
干预措施: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg) (Drug)
Control group
Active Comparator
Subject administered with Suvast tablet 10 mg (Rosuvastatin 10 mg)
干预措施: Suvast tablet 10 mg (Rosuvastatin 10 mg) (Drug)
结局指标
主要结局
Triglyceride (TG) change rate (percent, %)
时间窗: Baseline and 16 weeks
To compare Triglyceride (TG) change rate (percent,%)between test and control group
LDL-C change rate (percent, %)
时间窗: Baseline and 16 weeks
To compare LDL-C change rate (percent, %) between test and control group
次要结局
- Change rates (percent, %) of LDL-C and Triglyceride (TG)(Baseline and 4 weeks)
- Changes (mg/dL) of Total cholesterol (TC), Triglyceride (TG), HDL-C, and non-HDL-C(Baseline, 4 weeks, and 16 weeks)
- Changes of lipoproteins (ApoA1, ApoB)(Baseline and 16 weeks)
- Changes of lipoproteins (ApoB/ApoA1 ratio)(Baseline and 16 weeks)
- Percent (%) of subjects with a 50% or more reduction in LDL-C level(4 weeks and 16 weeks)
- Percent (%) of subjects with LDL-C below 70 mg/dL(4 weeks and 16 weeks)
- Change of HOMA-IR(Baseline and 16 weeks)
- Change of HbA1C (percentage, %)(Baseline, 4 weeks, and 16 weeks)
- Change (mg/dL) of Fasting Plasma Glucose (FPG)(Baseline, 4 weeks, and 16 weeks)
- Change (mg/dL) of hs-CRP(Baseline and 16 weeks)
- On the graphs at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC, total Area Under the Curve (tAUC) of each plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL)(Baseline and 16 weeks)
- Changes of plasma triglyceride (mg/dL), ApoB100 (mg/dL), and ApoB48 (mg/dL) levels at 30-minute, 1-, 2-, 3-, 4-, 5-, and 6-hour before and after FMC in subjects who perform FMC(Baseline and 16 weeks)
- Pulse(Baseline and 16 weeks)
- Adverse event(Baseline and 16 weeks)
- Blood pressure(Baseline and 16 weeks)
- Electrocardiogram (12-lead ECG)(-4 weeks and 16 weeks)
研究者
Soo Heon Kwak
Principal Investigator
Seoul National University Hospital
研究点 (26)
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