A Double Blind Placebo Controlled Study to Evaluate the Effects of Bexagliflozin on Hemoglobin A1c in Patients With Type 2 Diabetes and Increased Risk of Cardiovascular Adverse Events
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,700
- 试验地点
- 157
- 主要终点
- Change in HbA1c From Baseline to Week 24
研究概览
简要总结
The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events.
The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.
详细描述
Approximately 130 investigative sites globally are planned to participate in this study.
An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications.
The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of T2DM
- •Subjects who have had a stable treatment regimen for T2DM for the past 3 months
- •Subjects who present with at least one of the following 3 histories:
- •Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems
排除标准
- •Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- •History of genitourinary tract infections
- •Evidence of abnormal liver function
- •History of MI, stroke or hospitalization for heart failure in the past 3 months
- •Prior kidney transplant or evidence of kidney problems
- •Prior or planned pace maker implantation
- •Pregnant or nursing
研究组 & 干预措施
Bexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.
干预措施: Bexagliflozin (Drug)
Placebo tablets
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 24
时间窗: 24 weeks
The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with increased risk of cardiovascular adverse events.
次要结局
- Change in Body Weight From Baseline to Week 48(48 weeks)
- Change in Systolic Blood Pressure From Baseline to Week 24 in Subjects Hypertensive at Baseline(24 weeks)
- Change From Baseline in HbA1c at Week 24 for Subjects Who Have Been Prescribed Insulin(24 weeks)