NCT05814406已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With C2202 and C2204
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2023年1月12日最近更新:
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
- 196
- 试验地点
- 1
- 主要终点
- HbA1C (24 Weeks) lowering effect
研究概览
简要总结
A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2204
详细描述
A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study
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 2 Diabetes Mellitus
排除标准
- •Type 1 Diabetes Mellitus
- •The subject not meet the specified HbA1c and FPG
研究组 & 干预措施
JW0201+C2202+C2204
Experimental
Experimental group, Treatment period for 24 weeks
干预措施: JW0201 (Drug)
C2202+C2204
Placebo Comparator
Placebo group, Treatment period for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1C (24 Weeks) lowering effect
时间窗: 24 Weeks
change in HbA1c
次要结局
- HbA1c lowering effect(6, 12, 18 Weeks)
研究者
研究点 (1)
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