Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 45 - 75 |
| Updated: | 3/1/2014 |
| Start Date: | March 2013 |
| End Date: | May 2014 |
| Contact: | Kristin Newby, MD |
| Email: | kristin.newby@dm.duke.edu |
| Phone: | 919-668-8805 |
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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 your 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).
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 your 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).
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 CV outcomes. Approximately 74
subjects will be randomized and complete the study.
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 CV outcomes. Approximately 74
subjects will be randomized and complete the study.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Elevated Creatine Kinase-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 DPP-4 inhibitor
- Clinically apparent liver disease
- History of pancreatitis
We found this trial at
10
sites
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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