A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects WithType 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 765
- 试验地点
- 9
- 主要终点
- Change from baseline in seated systolic blood pressure
研究概览
简要总结
The current trial is designed to evaluate the effects of dapagliflozin on blood pressure when used in subjects with type 2 diabetes (T2DM) who have inadequate glycemic control and inadequately controlled hypertension while taking an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an additional antihypertensive medication.
In dapagliflozin Phase 2 and 3 studies, dose-dependent reductions in blood pressure have been observed in doses between 1.0 mg to 10 mg in monotherapy studies as well as in add-on to other oral hypoglycemic agents or insulin studies. These blood pressure reductions are consistent with the known osmotic diuretic effect of dapagliflozin, which results from its inhibition of proximal renal tubular glucose and sodium re-absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 89.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females, 18 to 65 years old, with type 2 diabetes with inadequate glycemic control HbA1c between 7-10% and uncontrolled hypertension SBP 140-165 and DBP 85-
- •Upper Limit of age of 65 years is in accordance with conditions set by Drug Controller General (India) for subjects participating from Indian sites.
- •Subjects must have a mean 24 hr blood pressure more than or equal to 130/80 determined by ABPM within 1 week prior to Day 1 visit.
- •Stable dose of oral antidiabetic agent (OAD) for 6 weeks (12 wks for TZD) and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for 4 weeks C-peptide more than or equal to .08 ng/mL Body Mass Index less than or equal to 45.0 kg/m2 Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women.
排除标准
- •AST and /or ALT 3.0 times the upper limit of normal (ULN) Serum total bilirubin more than 1.5 X ULN Creatinine kinase more than 3 X ULN Symptoms of severely uncontrolled diabetes History of malignant or accelerated hypertension Currently unstable or serious cardiovascular, renal, hepatic, hematological,oncological, endocrine, psychiatric, or rheumatic diseases.
结局指标
主要结局
Change from baseline in seated systolic blood pressure
时间窗: After 12 weeks
次要结局
- Change from baseline in HbA1c(After 12 weeks)