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 C2203
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 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 C2203
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+C2203
Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)
干预措施: Treatment Period(JW0201) (Drug)
JW0201+C2202+C2203
Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)
干预措施: Extension Period(JW0201) (Drug)
C2202+C2203
Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)
干预措施: Treatment Period(Placebo) (Drug)
C2202+C2203
Treatment period for 24 weeks (After the treatment period, take JW0201+C2202+C2203 for 28 weeks)
干预措施: Extension Period(JW0201) (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, 32, 40, 52 Weeks)