Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Saxagliptin

Intervention Type DRUG

one 5-mg saxagliptin tablet daily

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5mg placebo tablet daily

Interventions

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Saxagliptin

one 5-mg saxagliptin tablet daily

Intervention Type DRUG

Placebo

5mg placebo tablet daily

Intervention Type DRUG

Other Intervention Names

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Onglyza

Eligibility Criteria

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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-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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No