NCT07239440尚未招募2 期
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing BT-1 and BT-2 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
- 2 期
- 状态
- 尚未招募
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This study is a multicenter, double-blind, active-controlled, randomized, parallel clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing BT-1 and BT-2 combination therapy in patients with type 2 diabetes who have inadequate glycemic control
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 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
DA-2811-C
Experimental
DA-2811-C + DA-2811-R1
干预措施: DA-2811-C (Drug)
DA-2811
Experimental
DA-2811 + DA-2811-R2
干预措施: DA-2811 (Drug)
结局指标
主要结局
HbA1c
时间窗: Change from baseline at 12 weeks
次要结局
- HbA1c(Change from baseline at 24 weeks)
研究者
研究点 (1)
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