NCT01030679已完成2 期
To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 8
- 主要终点
- Change from baseline in fasting plasma glucose at 8 weeks
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type Ⅱ diabetes mellitus
- •Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
- •HbA1c between 7 and 11%
- •Body mass index (BMI) in the range 21-40
- •The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
- •Agreement with written informed consent
排除标准
- •Type I diabetes, gestational diabetes or secondary diabetes
- •Treatment with insulin(over 1month) within 3 months
- •Fasting Plasma Glucose level is over 270 mg/dl
- •Triglyceride level is 500 mg/dl and over
- •Uncontrollable hypertension
- •History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
- •Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)
- •Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
- •Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
- •In treatment concomitant drug having severe risk drug interaction with investigational drug
- •History of cancer within 5 years
- •History of drug abuse or alcoholism
- •Hepatitis B Antigen(HBsAg) test is positive
- •Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
- •Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
- •Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers
- •Has a contraindication to treatment investigational drug from the medical and psychogenic side
- •Participated in other trial within 4 weeks Participating in other trial at present
- •An impossible one who participates in clinical trial by legal or investigator's decision
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
CKD-501 0.5mg
Experimental
干预措施: CKD-501 0.5mg (Drug)
CKD-501 1mg
Experimental
干预措施: CKD-501 1mg (Drug)
CKD-501 2mg
Experimental
干预措施: CKD-501 2mg (Drug)
结局指标
主要结局
Change from baseline in fasting plasma glucose at 8 weeks
时间窗: 8 weeks
次要结局
- Change from baseline in Glycemic parameters after 8 weeks(8 weeks)
- Change from baseline in Lipid parameters after 8 weeks(8 weeks)
- Adverse event profile after 8 weeks of treatment(8 weeks)
研究者
研究点 (8)
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