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

Type 2 Diabetes Mellitus Clinical Trial

— MAPSS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01765270
• Other study ID #: Pro00041744
• Status: Terminated
• Phase: Phase 4
• First received: January 4, 2013
• Last updated: May 7, 2015
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Saxagliptin
one 5-mg saxagliptin tablet daily
• Placebo
5mg placebo tablet daily

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Cardio-Thoracic Surgeons PC	Birmingham	Alabama
United States	Cardiology, PC	Birmingham	Alabama
United States	Charleston Area Medical Center (CAMC)	Charleston	West Virginia
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
United States	Sparks Regional Medical Center	Fort Smith	Arkansas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Arkansas Cardiology, PA	Little Rock	Arkansas
United States	Stanford University Medical Center	Palo Alto	California
United States	Chippenham Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I (TnI) Area Under the Curve (AUC)		pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)	No
Secondary	High Sensitive Troponin-I (hsTnT) Area Under the Curve		pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)	No
Secondary	Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve		pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)	No
Secondary	Number of Major Adverse Cardiac Events (MACE)	Death, myocardial infarction (MI), or New congestive heart failure (CHF)	Baseline to end of study (Approximately 35-37 days)	No
Secondary	Duration of Inotropic Support		CABG surg until hosp discharge (Approximately 5 days)	No
Secondary	Number of Participants Who Had an Episode of Hypoglycemia		baseline to end of study (Approximately 35-37 days)	No
Secondary	Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support		CABG to hospital discharge (Approximately 5 days)	No
Secondary	Need for Antiarrhythmic Therapy		CABG surg to hospital discharge Approximately 5 days	No