NCT01392677已完成3 期
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change From Baseline in HbA1c Levels
研究概览
简要总结
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Men or women age ≥ 18 years old
- •Stable dose combination of metformin and sulfonylurea
- •HbA1c ≥7.7% and ≤11.0%
排除标准
- •Type 1 diabetes mellitus or diabetes insipidus
- •Recent cardiovascular events
- •Kidney or urological disorders
- •Hepatic disorders
研究组 & 干预措施
Dapagliflozin 10 mg tablet
Experimental
干预措施: dapagliflozin (Drug)
matching placebo tablet
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in HbA1c Levels
时间窗: Baseline to week 24
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
次要结局
- Adjusted Mean Change From Baseline in FPG(Baseline to week 24)
- Adjusted Mean Change From Baseline in Total Body Weight(Baseline to week 24)
- Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)(Baseline to week 24)
- Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure(Baseline to week 8)
研究者
研究点 (1)
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