NCT05743907已完成4 期
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy 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
- 4 期
- 状态
- 已完成
- 入组人数
- 231
- 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, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy 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
- •Subjects with 7.0%≤HbA1c≤10.0% at screening
- •Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
- •Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
- •Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
排除标准
- •Subjects with fasting plasma glucose≥240mg/dL at screening
- •Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- •Subject with ALT and AST 3 times or higher than upper normal range
- •Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
研究组 & 干预措施
DA-2811
Experimental
DA-2811 + Forxiga placebo
干预措施: DA-2811 (Drug)
Forxiga
Active Comparator
Forxiga + DA-2811 placebo
干预措施: Forxiga (Drug)
结局指标
主要结局
HbA1c(%)
时间窗: Change from baseline at 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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