NCT00972244已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus 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
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change in HbA1c Levels
研究概览
简要总结
The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese Subjects with type 2 diabetes mellitus.
- •Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
- •Provision of informed consent.
排除标准
- •Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
- •The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
研究组 & 干预措施
1
Experimental
1mg dapagliflozin
干预措施: Dapagliflozin (Drug)
2
Experimental
2.5mg dapagliflozin
干预措施: Dapagliflozin (Drug)
3
Experimental
5mg dapagliflozin
干预措施: Dapagliflozin (Drug)
4
Experimental
10mg dapagliflozin
干预措施: Dapagliflozin (Drug)
5
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adjusted Mean Change in HbA1c Levels
时间窗: Baseline to Week 12
The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.
次要结局
- Adjusted Mean Change in Fasting Plasma Glucose(Baseline to Week 12)
- Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%(At Week 12)
研究者
研究点 (1)
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