NCT01294423已完成3 期
A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c Levels
研究概览
简要总结
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization
排除标准
- •Type 1 diabetes mellitus
- •FPG >240 mg/dL before randomization
- •Subjects who have history of unstable or rapidly progressing renal disease
- •Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
- •Significant cardiovascular history
研究组 & 干预措施
1
Experimental
Dapagliflozin 5 mg
干预措施: Dapagliflozin (Drug)
2
Experimental
Dapagliflozin 10 mg
干预措施: Dapagliflozin (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: From Baseline to Week 24
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
次要结局
- Adjusted Mean Change in Fasting Plasma Glucose (FPG)(From Baseline to Week 24)
- Adjusted Mean Change in Body Weight(From Baseline to Week 24)
研究者
研究点 (1)
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