Randomized, Open-label, Multi-centered Study to Evaluate the Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia(Phase 4)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- The change of HbA1c before and after taking LIVALO®
研究概览
简要总结
Primary Objective
: To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG).
H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4
µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
详细描述
Investigational Product Test group: Pitavastatin calcium (LIVALO) 4mg tab Control group: Pitavastatin calcium (LIVALO) 2mg tab
Study Site: Multi-centers in Korea
Period: For 24months after IRB approval at each site (Including 12months of subject enrollment period)
Efficacy End points
A. Primary end point The change of HbA1c before and after taking LIVALO
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients who are more than 20 years old or 70 years old or less.
- •Patient who voluntarily sign on written informed consent form
- •Patient who LDL-C ≥ 100mg/dl or was diagnosed with hyperlipidemia
- •Patient who was suspected with Imparied Fasting Glucose (IFG) and satisfy FPG level ≥ 100mg/dL and < 126mg/dL when FPG measured twice.
排除标准
- •Patient who has familial hypercholesterolemia
- •Patient who has been diagnosed with Type1, Type2 DM or secondary DM(diabetes mellitus) at the screening visit (Diagnostic criteria of DM: HbA1c≥ 6.5%)
- •Patient who has received antidiabetic within 6weeks to the screening visit
- •Patient who has been taking insulin continuously or to be needed in the future
- •Patient who has a history of gastrectomy
- •Patient who is suspected or diagnosed with malignant tumor within last 10 years
- •Patient who has serious pancreatic disease or endocrine disorders
- •Patient who currently takes Cyclosporine
- •Patient who has a medical history of hypersensitivity to Pitavastatin calcium
- •Patient who has suspected renal failure (serum creatinine ≥2.0 mg/dL)
- •Patient who has suspected liver dysfunction (more than 2.5 times the upper limit of normal AST or ALT)
- •Patient who has more than 3 times the upper limit of normal CPK
- •Patient who is breastfeeding, pregnant or planning pregnancy
- •Patient who deemed inappropriate as subject in the opinion of the Principal Investigator or Investigator
研究组 & 干预措施
Pitavastatin calcium 4mg
Pitavastatin calcium (LIVALO®) 4mg, once a day
干预措施: Pitavastatin calcium 4mg (Drug)
Pitavastatin calcium 2mg
Pitavastatin calcium (LIVALO®) 2mg, once a day
干预措施: Pitavastatin calcium 2mg (Drug)
结局指标
主要结局
The change of HbA1c before and after taking LIVALO®
时间窗: 24 weeks after taking IP
次要结局
- The change of the lipid composition (T-chol, TG, LDL-C, HDL-C, ApoA1/ApoB)(24weeks and 1 year after registration)
- The changes of hs-CRP, Adiponectin, blood glucose and Insulin levels(24weeks and 1 year after registration)
- Incidence of total cardiovascular (TVR-MACE) events(within 1 year after registration)
- Incidence of diabetes(within 1year after registration)