NCT06290349进行中（未招募）3 期
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
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）
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change from the baseline in HbA1c (%) after 24 weeks
研究概览
简要总结
This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple 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
- 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
- •Patients with type II diabetes mellitus aged 19 years or older
- •Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit
- •Patients with fasting plasma glucose≤270mg/dL at the screening visit
- •Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit
- •Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study
排除标准
- •Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis
- •Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure
- •Patients with severe infectious disease or severe traumatic systemic disorders
- •Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
- •Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption
研究组 & 干预措施
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Experimental
干预措施: DA5221-T1 (Drug)
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Experimental
干预措施: DA5221-B1 (Drug)
DA5221-T1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Experimental
干预措施: DA5221-B2 (Drug)
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2
Experimental
干预措施: DA5221-T2 (Drug)
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2
Experimental
干预措施: DA5221-B1 (Drug)
DA5221-R1 + DA5221-T2 + DA5221-B1 + DA5221-B2
Experimental
干预措施: DA5221-B2 (Drug)
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Placebo Comparator
干预措施: Placebo (Drug)
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Placebo Comparator
干预措施: DA5221-B1 (Drug)
DA5221-R1 + DA5221-R2 + DA5221-B1 + DA5221-B2
Placebo Comparator
干预措施: DA5221-B2 (Drug)
结局指标
主要结局
Change from the baseline in HbA1c (%) after 24 weeks
时间窗: Baseline, 24 weeks
次要结局
- Change from the baseline in weight after 24 weeks(Baseline, 24 weeks)
- Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks(Baseline, 24 weeks)
- Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks(Baseline, 24 weeks)
研究者
研究点 (1)
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