A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,996
- 试验地点
- 161
- 主要终点
- Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
研究概览
简要总结
The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.
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 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dapagliflozin, 10 mg
Oral tablets administered as 10 mg once daily for up to 12 weeks
干预措施: Dapagliflozin (Drug)
Placebo-matching dapagliflozin
Oral tablets administered once daily in the morning
干预措施: Placebo-matching dapagliflozin (Drug)
Dapagliflozin, 2. 5 mg
Oral tablets administered as 2.5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
干预措施: Dapagliflozin (Drug)
Dapagliflozin, 5 mg
Oral tablets administered as 5 mg once daily for up to 12 weeks (Arm discontinued as of Protocol Amendment 8)
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
时间窗: From Baseline to Week 12
Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12
时间窗: From Baseline to Week 12
HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.
次要结局
- Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12(From Baseline to Week 12)
- Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])(From Baseline to Week 12)
- Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)(From Baseline to Week 12)
- Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12(From Baseline to Week 12)
