Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 10
- 主要终点
- Troponin I (TnI) Area Under the Curve (AUC)
研究概览
简要总结
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery. The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).
详细描述
This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes. Approximately 74 subjects will be randomized and complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.
- •Stable doses of oral antihyperglycemic agents for at least 2 months
- •Stable dose of chronic insulin therapy for at least 2 months
- •HbA1c documented within 3 months before study enrollment
- •Planned first elective coronary artery bypass graft (CABG) surgery
排除标准
- •Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
- •Receiving incretin therapy or having received incretin therapy within the previous 2 months
- •Type 1 DM or a history of ketoacidosis
- •Women who are pregnant or breastfeeding
- •Known end-stage Kidney disease
- •Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4) inhibitor
- •Clinically apparent liver disease
- •History of pancreatitis
研究组 & 干预措施
Saxagliptin
Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
干预措施: Saxagliptin (Drug)
Placebo
Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Troponin I (TnI) Area Under the Curve (AUC)
时间窗: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
次要结局
- High Sensitive Troponin-I (hsTnT) Area Under the Curve(pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days))
- Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve(pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days))
- Number of Major Adverse Cardiac Events (MACE)(Baseline to end of study (Approximately 35-37 days))
- Duration of Inotropic Support(CABG surg until hosp discharge (Approximately 5 days))
- Number of Participants Who Had an Episode of Hypoglycemia(baseline to end of study (Approximately 35-37 days))
- Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support(CABG to hospital discharge (Approximately 5 days))
- Need for Antiarrhythmic Therapy(CABG surg to hospital discharge Approximately 5 days)