NCT06571591进行中（未招募）3 期
A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone Co-administration in Patients With Type II Diabetes With Insufficient Glycemic Control With Metformin and Empagliflozin Combination Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celltrion
- 入组人数
- 582
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination 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
- 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
- •Adults at the time of signing the Informed Consent Form (ICF)
- •Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
- •Diagnosed with T2DM
排除标准
- •Diagnosed with other types of diabetes than T2DM
- •History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy
- •Uncontrolled severe complications of diabetes
研究组 & 干预措施
Group 1
Active Comparator
干预措施: CT-L03 Group 1 (Drug)
Group 2
Active Comparator
干预措施: CT-L03 Group 2 (Drug)
Group 1
Active Comparator
干预措施: Empagliflozin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Group 1
Active Comparator
干预措施: Metformin (Drug)
Group 2
Active Comparator
干预措施: Empagliflozin (Drug)
Group 2
Active Comparator
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
干预措施: Empagliflozin (Drug)
Placebo
Placebo Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
HbA1c
时间窗: Week 24 of the Treatment
Change from Baseline in HbA1c
次要结局
- HbA1c(Week 12 of the Treatment)
- Body weight(Week 12 and 24 of the Treatment)
- FPG(Week 12 and 24 of the Treatment)
研究者
研究点 (1)
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