A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of AD-233A, AD-233B, AD-233C and/or AD-233D Combination Therapy in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 354
- 主要终点
- Change in HbA1c from baseline at Week 24 after administration of IP
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of AD-233A, AD-233B, AD-233C and/or AD-233D combination therapy
详细描述
Condition or disease: Type 2 Diabetes Mellitus
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
- Double (Participant, Investigator)
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
- •Signed informed consent
- •Other inclusions applied
排除标准
- •Subjects with severe diabetic complications
- •Other exclusions applied
研究组 & 干预措施
Test Group
AD-233A+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233A (Drug)
Test Group
AD-233A+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233B (Drug)
Test Group
AD-233A+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233C (Drug)
Test Group
AD-233A+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233D (Drug)
Control Group 1
AD-233A Placebo+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233B (Drug)
Control Group 1
AD-233A Placebo+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233C (Drug)
Control Group 1
AD-233A Placebo+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233D (Drug)
Control Group 1
AD-233A Placebo+AD-233B+AD-233C and/or AD-233D
干预措施: AD-233A Placebo (Drug)
Control Group 2
AD-233A+AD-233B Placebo+AD-233C and/or AD-233D
干预措施: AD-233A (Drug)
Control Group 2
AD-233A+AD-233B Placebo+AD-233C and/or AD-233D
干预措施: AD-233C (Drug)
Control Group 2
AD-233A+AD-233B Placebo+AD-233C and/or AD-233D
干预措施: AD-233D (Drug)
Control Group 2
AD-233A+AD-233B Placebo+AD-233C and/or AD-233D
干预措施: AD-233B Placebo (Drug)
结局指标
主要结局
Change in HbA1c from baseline at Week 24 after administration of IP
时间窗: Baseline, Week 24
Change in HbA1c(Hemoglobin a1c) from baseline at Week 24 after administration of IP(Investigator's Product)
时间窗: Baseline, Week 24
次要结局
未报告次要终点