- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765270
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery (MAPSS)
May 7, 2015 updated by: Duke University
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 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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35211
- Cardiology, PC
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Birmingham, Alabama, United States, 35243
- Cardio-Thoracic Surgeons PC
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Huntsville, Alabama, United States, 35801
- Heart Center Research, LLC
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Arkansas
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Fort Smith, Arkansas, United States, 72901
- Sparks Regional Medical Center
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Little Rock, Arkansas, United States, 72205
- Arkansas Cardiology, PA
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California
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Palo Alto, California, United States, 94304
- Stanford University Medical Center
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center (DUMC)
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Virginia
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Richmond, Virginia, United States, 23225
- Chippenham Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25304
- Charleston Area Medical Center (CAMC)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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one 5-mg saxagliptin tablet daily
Other Names:
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Placebo Comparator: 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.
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5mg placebo tablet daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Troponin I (TnI) Area Under the Curve (AUC)
Time Frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High Sensitive Troponin-I (hsTnT) Area Under the Curve
Time Frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve
Time Frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
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Number of Major Adverse Cardiac Events (MACE)
Time Frame: Baseline to end of study (Approximately 35-37 days)
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Death, myocardial infarction (MI), or New congestive heart failure (CHF)
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Baseline to end of study (Approximately 35-37 days)
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Duration of Inotropic Support
Time Frame: CABG surg until hosp discharge (Approximately 5 days)
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CABG surg until hosp discharge (Approximately 5 days)
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Number of Participants Who Had an Episode of Hypoglycemia
Time Frame: baseline to end of study (Approximately 35-37 days)
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baseline to end of study (Approximately 35-37 days)
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Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support
Time Frame: CABG to hospital discharge (Approximately 5 days)
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CABG to hospital discharge (Approximately 5 days)
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Need for Antiarrhythmic Therapy
Time Frame: CABG surg to hospital discharge Approximately 5 days
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CABG surg to hospital discharge Approximately 5 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: L. Kristin Newby, M.D., MHS, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 4, 2013
First Submitted That Met QC Criteria
January 8, 2013
First Posted (Estimate)
January 10, 2013
Study Record Updates
Last Update Posted (Estimate)
May 29, 2015
Last Update Submitted That Met QC Criteria
May 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Cardiovascular Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Saxagliptin
Other Study ID Numbers
- Pro00041744
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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