NCT01529528已完成3 期
A Multicenter, Randomized, Double Blind, Placebo Controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate Efficacy and Safety of CWP-0403 in Type 2 DM Patients
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- The Change in HbA1c from baseline to week24
研究概览
简要总结
This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 DM patients
- •Subjects who couldn't control the blood glucose despite of a dietary and exercise therapy more than 6 weeks at screening visit
- •FPG ≤ 270mg/dL at screening visit
- •Patients who consent to participate in this trial by written Informed Consent Form
排除标准
- •Type 1 DM or secondary diabetes
- •Subjects who are administrating insulin or need to insulin therapy
- •History of oral anti-hyperglycemic drugs within 6 weeks before screening visit
- •Body mass index < 20 kg/m2 or > 40.0kg/m2
- •Subjects who are assessed to be inappropriate for this trial by investigator
研究组 & 干预措施
Placebo of CWP-0403 100mg
Placebo Comparator
Placebo of CWP-0403 100mg
干预措施: Placebo of Anagliptin (Drug)
CWP-0403 200mg
Experimental
CWP-0403 200mg
干预措施: Anagliptin (Drug)
CWP-0403 100mg
Experimental
CWP-0403 100mg
干预措施: Anagliptin (Drug)
结局指标
主要结局
The Change in HbA1c from baseline to week24
时间窗: 0wk, 8wk, 16wk, 24wk
次要结局
- change from baseline to week 24 in HOMA-β(owjm 24wk)
- The proportion of subjects achieving HbA1c<7% at week24(0wk, 8wk, 16wk, 24wk)
- The change from baseline to week 24: Fasting plasma glucose(0wk, 24wk)
- change from baseline to week 24 in Fasting serum pro-insulin(0 wk, 24wk)
- change from baseline to week 24 in Fasting serum insulin(0 wk, 24 wk)
- The proportion of subjects achieving HbA1c<6.5% at week24(0wk, 8wk, 16wk, 24wk)
- change in from baseline to week 24 fasting serum c-peptide(0wk, 24wk)
- change from baseline to week 24 in HOMA-IR(0wk, 24 wk)
研究者
研究点 (1)
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