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

NCT01765270 | Terminated Phase 4 Results

• 1 other identifier: Pro00041744
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Type 2 Diabetes Mellitus; Cardiovascular Disease

Keywords

Diabetes; Diabetes Mellitus; Type 2 Diabetes; Cardiovascular Disease; Coronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• 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)

• 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)

• Number of Major Adverse Cardiac Events (MACE)

  Baseline to end of study (Approximately 35-37 days)

• Duration of Inotropic Support

  CABG surg until hosp discharge (Approximately 5 days)

• Number of Participants Who Had an Episode of Hypoglycemia

  baseline to end of study (Approximately 35-37 days)

Study Arms (2)

Saxagliptin

ACTIVE COMPARATOR

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.

Drug: Saxagliptin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Saxagliptin DRUG

one 5-mg saxagliptin tablet daily

Also known as: Onglyza

Saxagliptin

Placebo DRUG

5mg placebo tablet daily

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (10)

Cardiology, PC

Birmingham, Alabama, 35211, United States

Location

Cardio-Thoracic Surgeons PC

Birmingham, Alabama, 35243, United States

Location

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States

Location

Arkansas Cardiology, PA

Little Rock, Arkansas, 72205, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710, United States

Location

Chippenham Medical Center

Richmond, Virginia, 23225, United States

Location

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Early termination leading to small numbers of subject analyzed.

Results Point of Contact

• Title: L. Kristin Newby, MD, MHS
• Organization: Duke Clinical Research Institute

kristin.newby@duke.edu

919-668-8805

Study Officials

• L. Kristin Newby, M.D., MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 10, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 29, 2015
• Results First Posted: May 8, 2015

Record last verified: 2015-04

Locations

US (10)