NCT05666128已完成2 期
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Hyundai Pharm1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2022年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in HbA1c(%) at weeks 12 from baseline
研究概览
简要总结
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 6 weeks prior to screening.
排除标准
- •Type 1 diabetes or another immune-mediated diabetes syndrome
研究组 & 干预措施
HD-6277 100mg
Experimental
干预措施: HD-6277 (Drug)
HD-6277 50mg
Experimental
干预措施: HD-6277 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c(%) at weeks 12 from baseline
时间窗: at weeks 12 from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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