NCT07093476招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Celltrion
- 入组人数
- 171
- 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-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin 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
Study group 1
Active Comparator
Metformin + Alogliptin + Empagliflozin Xmg
干预措施: Metformin (Drug)
Study group 1
Active Comparator
Metformin + Alogliptin + Empagliflozin Xmg
干预措施: Alogliptin (Drug)
Study group 1
Active Comparator
Metformin + Alogliptin + Empagliflozin Xmg
干预措施: empagliflozin (Drug)
Study group 2
Active Comparator
Metformin + Alogliptin + Empagliflozin Ymg
干预措施: Metformin (Drug)
Study group 2
Active Comparator
Metformin + Alogliptin + Empagliflozin Ymg
干预措施: Alogliptin (Drug)
Study group 2
Active Comparator
Metformin + Alogliptin + Empagliflozin Ymg
干预措施: empagliflozin (Drug)
Control Group
Placebo Comparator
Metformin + Alogliptin
干预措施: Metformin (Drug)
Control Group
Placebo Comparator
Metformin + Alogliptin
干预措施: Alogliptin (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
未报告次要终点
研究者
研究点 (1)
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