Trial Outcomes & Findings for Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery (NCT NCT01765270)

NCT ID: NCT01765270

Last Updated: 2015-05-29

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
• Results posted on: 2015-05-29

Participant Flow

Participant milestones

Measure	Saxagliptin Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.	Placebo Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
Overall Study STARTED	5	7
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Saxagliptin Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.	Placebo Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.	Total n=10 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 5.3 • n=5 Participants	60.2 years STANDARD_DEVIATION 8.1 • n=7 Participants	59.2 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Troponin I (TnI) Area Under the Curve (AUC)	463.25 ng*hr/mL Interval 228.74 to 928.29	235.98 ng*hr/mL Interval 230.03 to 266.01

SECONDARY outcome

Timeframe: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
High Sensitive Troponin-I (hsTnT) Area Under the Curve	213.82 ng*hr/mL Interval 114.09 to 265.03	129.14 ng*hr/mL Interval 58.25 to 181.61

SECONDARY outcome

Timeframe: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve	1174.9 ng*hr/mL Interval 1057.36 to 1301.66	835.76 ng*hr/mL Interval 744.84 to 885.81

SECONDARY outcome

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

Death, myocardial infarction (MI), or New congestive heart failure (CHF)

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Number of Major Adverse Cardiac Events (MACE)	0 Cardiac Events	0 Cardiac Events

SECONDARY outcome

Timeframe: CABG surg until hosp discharge (Approximately 5 days)

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Duration of Inotropic Support	25.67 hours Standard Deviation 23.58	8.49 hours Standard Deviation 7.60

SECONDARY outcome

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

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Number of Participants Who Had an Episode of Hypoglycemia	0 participants	0 participants

SECONDARY outcome

Timeframe: CABG to hospital discharge (Approximately 5 days)

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support	0 participants	0 participants

SECONDARY outcome

Timeframe: CABG surg to hospital discharge Approximately 5 days

Outcome measures

Measure	Saxagliptin n=4 Participants 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.	Placebo n=6 Participants 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.
Need for Antiarrhythmic Therapy	4 participants	4 participants

Adverse Events

Saxagliptin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Saxagliptin n=4 participants at risk 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.	Placebo n=6 participants at risk 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.
Cardiac disorders atrial fibrillation	25.0% 1/4 • Participants were followed for aproximately 35 days (5 days before CABG and typically 30 days after CABG).	16.7% 1/6 • Participants were followed for aproximately 35 days (5 days before CABG and typically 30 days after CABG).
Injury, poisoning and procedural complications Pulmonary embolism	0.00% 0/4 • Participants were followed for aproximately 35 days (5 days before CABG and typically 30 days after CABG).	16.7% 1/6 • Participants were followed for aproximately 35 days (5 days before CABG and typically 30 days after CABG).

Additional Information

L. Kristin Newby, MD, MHS

Duke Clinical Research Institute

Phone: 919-668-8805

Email: kristin.newby@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place