A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints with Type 2 Diabetes Inadequately Controlled with D150 Plus D759
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.
详细描述
The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 19 years and 85 years old(male or female)
- •Type 2 diabetes mellitus
- •BMI between 18.5kg/m2 and 40kg/m2
- •Agreement with written informed consent
排除标准
- •Type 1 diabetes mellitus or secondary diabetes mellitus
- •Patients with complications of severe diabetes such as proliferative diabetic retinopathy
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients with abnormal laboratory test results according to the protocol
- •Continuous or non continuous treatment insulin within 12 weeks prior to screening
- •Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening
研究组 & 干预措施
Expermental group 1
Pateints assigned to this group are treated with D150, D759 and D745 formulation I
干预措施: D745 formulation I (Drug)
Experimental group 2
Pateints assigned to this group are treated with D150, D759 and D745 formulation II
干预措施: D745 formulation II (Drug)
Placebo group
Pateints assigned to this group are treated with D150, D759 and D745 placebo
干预措施: D745 Placebo (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline, 24 week
次要结局
- Change from baseline in HbA1c(Baseline, 12 week)
- Change from baseline in Fasting plasma glucose(Baseline, 12 week, 24 week)