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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01765270
• Date of registration: 04/01/2013
• Prospective Registration: Yes
• Primary sponsor: Duke University
• Public title: Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery MAPSS
• Scientific title: Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
• Date of first enrolment: March 2013
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01765270
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: L. Kristin Newby, M.D., MHS
• Affiliation: Duke University

Key inclusion & exclusion 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-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



Age minimum: 45 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Cardiovascular Disease

Intervention(s)

Drug: Saxagliptin

Drug: Placebo

Primary Outcome(s)

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)]

Secondary Outcome(s)

Need for Antiarrhythmic Therapy [Time Frame: CABG surg to hospital discharge Approximately 5 days]

Number of Major Adverse Cardiac Events (MACE) [Time Frame: Baseline to end of study (Approximately 35-37 days)]

Duration of Inotropic Support [Time Frame: CABG surg until hosp discharge (Approximately 5 days)]

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)]

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)]

Number of Participants Who Had an Episode of Hypoglycemia [Time Frame: baseline to end of study (Approximately 35-37 days)]

Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support [Time Frame: CABG to hospital discharge (Approximately 5 days)]

Secondary ID(s)

Pro00041744

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01765270