Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus, Cardiovascular Disease
In brief
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).
Key facts
- Study ID
- NCT01765270
- Run by
- Duke University
- People needed
- 12
- Starts
- 2013-03-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-05-29
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cardiology, PC — Birmingham, Alabama, United States
- Cardio-Thoracic Surgeons PC — Birmingham, Alabama, United States
- Heart Center Research, LLC — Huntsville, Alabama, United States
- Sparks Regional Medical Center — Fort Smith, Arkansas, United States
- Arkansas Cardiology, PA — Little Rock, Arkansas, United States
- Stanford University Medical Center — Palo Alto, California, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Duke University Medical Center (DUMC) — Durham, North Carolina, United States
- Chippenham Medical Center — Richmond, Virginia, United States
- Charleston Area Medical Center (CAMC) — Charleston, West Virginia, United States
Full record on ClinicalTrials.gov
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