A Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Empagliflozin (10mg, 25mg) Administered Orally, Once Daily Over 24 Weeks in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 89
- 主要终点
- Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks
研究概览
简要总结
This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant, new information for the use of empagliflozin.
Essential hypertension is four times more common in African Americans than in Caucasians.
One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake. There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus.
The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP (DBP) at 12 and 24 weeks.
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
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Empagliflozin
starting dose 10mg; forced titration after 4 weeks 25mg dose
干预措施: Empagliflozin low dose (Drug)
Empagliflozin
starting dose 10mg; forced titration after 4 weeks 25mg dose
干预措施: Empagliflozin high dose (Drug)
Placebo
starting dose 10mg; forced titration after 4 weeks 25mg dose
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks
时间窗: baseline and 24 weeks
Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.
次要结局
- Changes From Baseline in Trough Mean Ambulatory SBP at Week 12(baseline and 12 weeks)
- Change From Baseline in Body Weight at Week 24(baseline and 24 weeks)
- Change From Baseline in Trough Seated SBP at Week 12(baseline and 12 weeks)
- Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12(baseline and 12 weeks)
- Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24(baseline and 24 weeks)
- Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12(baseline and 12 weeks)
- Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24(baseline and 24 weeks)
- Change From Baseline in Trough Seated SBP (mmHg) at Week 24(baseline and 24 weeks)
- Change From Baseline in Trough Seated DBP (mmHg) at Week 12(baseline and 12 weeks)
- Change From Baseline in Trough Seated DBP (mmHg) at Week 24(baseline and 24 weeks)