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

This study is currently recruiting participants.
Verified May 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01765270
First received: January 4, 2013
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Cardiovascular Disease
 Drug: Saxagliptin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Resource links provided by NLM:

Drug Information available for: Saxagliptin
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • The effect of saxagliptin on cardiac biomarkers [ Time Frame: Baseline, 5-7 days of study treatment, intraop, post-op, discharge, and 30 days of study treatment ] [ Designated as safety issue: No ]
    To evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis in subjects with T2DM undergoing CABG (on pump, via a median sternotomy approach) as one measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes.


Secondary Outcome Measures:
  • The effect of saxagliptin on clinical and biomarker variables and safety [ Time Frame: Baseline, 5-7 days of study treatment, intraop, post-op, discharge, and 30 days of study treatment ] [ Designated as safety issue: Yes ]
    To evaluate the effect of saxagliptin on clinical and biomarker variables and safety as an integrated measure of the potential mechanistic actions of saxagliptin on prevention of CV outcomes.


Estimated Enrollment: 84
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saxagliptin
5-mg saxagliptin tablet once per day for maximum of 45 days
 Drug: Saxagliptin
one 5-mg saxagliptin tablet or matching placebo daily
Other Name: Onglyza
Placebo Comparator: Placebo
5-mg tablet once per day for a maximum of 45 days

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 CV outcomes. Approximately 74 subjects will be randomized and complete the study.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765270

Contacts
Contact: Kristin Newby, MD 919-6968-8805 kristin.newby@dm.duke.edu
Contact: Schuyler Jones, MD 919-668-8917 schuyler.jones@dm.duke.edu

Locations
United States, California
Stanford University Medical Center Not yet recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Michael Fischbein, MD            
United States, Georgia
Emory University Hospital Midtown Not yet recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Vinod Thourani, MD            
United States, North Carolina
Duke University Medical Center (DUMC) Recruiting
Durham, North Carolina, United States, 27710
Contact: Jacob Schroder, MD     919-681-7862     jacob.schroder@duke.edu    
Principal Investigator: Jacob Schroder, MD            
United States, West Virginia
Charleston Area Medical Center (CAMC) Recruiting
Charleston, West Virginia, United States, 25304
Principal Investigator: Firasat Malik, MD            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: L. Kristin Newby, M.D., MHS Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01765270     History of Changes
Other Study ID Numbers: Pro00041744
Study First Received: January 4, 2013
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Diabetes
Diabetes Mellitus
Type 2 Diabetes
Cardiovascular Disease
Coronary Artery Bypass Surgery

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013