NCT00888719已完成2 期
A Prospective, Randomized, Double Blinded, Multicenter and Therapeutic Exploratory Study to Comparatively Assess Efficacy and Safety of CWP-0403 in Type 2 Diabetes Patients Who Are Insufficiently Controlled by Diet and Exercise.
JW Pharmaceutical10 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 10
- 主要终点
- Change in HbA1c before and after treatment
研究概览
简要总结
Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of≥25 and <75 with typeⅡ DM patients
- •Patients whose level of HbA1c is over 7.0% and less than 10% within 4weeks of screening registration
- •In spite of dietary and exercise treatment over 8weeks, the level of HbA1c is over 6.5% and less than 10%.
- •BMI between 20kg/㎡ and 40kg/㎡
- •Out patients
- •patients who agree the trial participation with written informed consent
排除标准
- •TypeⅠDM, Gestational diabetes.
- •Patients who are being treated with insulin
- •Fasting glucose level over 250mg/dL
- •Patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (Evaluated "Bad" and worse)
- •Severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or AST or ALT level over 2.5times as high as UNL on screening visit.
- •Severe renal dysfunctions (i.e.: renal failure) or serum creatinine level over 1.5mg/dl
- •Severe cardiac dysfunction(i.e.: heart failure ) or history of myocardial infarction within 6months of screening
- •Chronic pulmonary disease or pulmonary infarction
- •Pancreatitis patients
- •Patients who are being treated for life threatening disease such as cancer, severe trauma or infection.
- •Uncontrollable diabetic complications(neuropathy, retinopathy, nephrosis)
- •Severe ketosis or experience of diabetic coma
- •Intestinal disease affecting digestion or absorption or history of GI dissection surgery except for appendectomy.
- •Pregnant, expecting to be pregnant or nursing female
- •Excessive alcohol consumption (Over 80g of alcohol/day: Over 1 bottle of 360ml Soju/day)
- •Participants of other clinical trials within 3 months of screening
- •Patients medicated with following non-concomitant medications Insulins or oral antidiabetics Oral (for more than 1 week) or IV corticosteroids (External and inhaled corticosteroids excluded) appetite suppressant exenatide or other GLP-1 analogues Other medications in development
- •Hypersensitive or intolerance to DPP4 inhibitory
- •patients who are decided to be inappropriate for this trial subject by the investigators
研究组 & 干预措施
CWP-0403 50mg
Experimental
干预措施: CWP-0403 50mg (Drug)
CWP-0403 100mg
Experimental
干预措施: CWP-0403 100mg (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in HbA1c before and after treatment
时间窗: 12 weeks
次要结局
- HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)(12 weeks)
- Fasting blood glucose level change and rate of change(12 weeks)
- Serum insulin, serum C-peptide level change(12 weeks)
- HOMA-R and HOMA-β change rate(12 weeks)
- Triglyceride, LDL-cholesterol and HDL-cholesterol change(12 weeks)
研究者
研究点 (10)
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