Trial Outcomes & Findings for Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery (NCT NCT02556918)

NCT ID: NCT02556918

Last Updated: 2019-12-23

Results Overview

Number of patients with blood glucose (BG) levels greater than 180 mg/dl

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 202 participants
• Primary outcome timeframe: 2 days (average time of discharge from ICU)
• Results posted on: 2019-12-23

Participant Flow

One participant died during hospital admission before receiving study medication.

Participant milestones

Measure	Sitagliptin Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100	Placebo Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Overall Study STARTED	100	101
Overall Study COMPLETED	91	91
Overall Study NOT COMPLETED	9	10

Reasons for withdrawal

Measure	Sitagliptin Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100	Placebo Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Overall Study Protocol Violation	5	6
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery

Baseline characteristics by cohort

Measure	Sitagliptin n=100 Participants Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.	Placebo n=101 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.	Total n=201 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 9.1 • n=5 Participants	63.3 years STANDARD_DEVIATION 7.8 • n=7 Participants	63.8 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	71 Participants n=7 Participants	148 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	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	74 Participants n=7 Participants	146 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	101 participants n=7 Participants	201 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Number of patients with blood glucose (BG) levels greater than 180 mg/dl

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)	76 Participants	68 Participants

PRIMARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of patients with two consecutive fasting and/or pre-meal blood glucose (BG) greater than 180 mg/dl, or with average daily BG greater than 80 mg/dl who require rescue therapy with subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients With Persistent Hyperglycemia	58 Participants	59 Participants

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)	86 Participants	85 Participants

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Mean blood glucose (BG) concentration of ICU patients during recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)	148.7 mmol/L Standard Deviation 15.8	149.8 mmol/L Standard Deviation 16.0

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Total IV insulin in ICU during recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Total IV Insulin in ICU	100.43 units Standard Deviation 123.44	95.68 units Standard Deviation 118.32

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Mean insulin infusion dose per day of ICU patients during recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery	45.9 unit/day Standard Deviation 36.1	46.4 unit/day Standard Deviation 36.0

SECONDARY outcome

Timeframe: Up to 48 hours (average time of discharge from ICU)

Total hours of continuous intravenous insulin infusion (CII)

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Duration of Continuous Intravenous Insulin Infusion (CII)	27.7 hours Standard Deviation 27.6	27.7 hours Standard Deviation 28.0

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Population: Some patients were not transitioned to SQ insulin because they stayed on CII due to complications, these patients were taken off the analysis

Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII)

Outcome measures

Measure	Sitagliptin n=87 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=86 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)	74 Participants	78 Participants

SECONDARY outcome

Timeframe: Up to 14 days (time of discharge from the hospital)

Population: Some patients were not transitioned to SQ insulin because they stayed on CII due to complications, these patients were taken off the analysis

Median number of days patients requiring SC insulin after discontinuation of CII

Outcome measures

Measure	Sitagliptin n=87 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=86 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)	4 days Interval 0.0 to 14.0	4 days Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Mean post-operative blood glucose (BG) concentration during recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Mean Post-operative Blood Glucose (BG) Concentration	154.2 mmol/L Standard Deviation 29.0	156.5 mmol/L Standard Deviation 36.1

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Total amount of SC insulin taken by ICU patients during recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)	1.0 units Standard Deviation 6.4	2.2 units Standard Deviation 13.1

SECONDARY outcome

Timeframe: 48 hours during recovery period

Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours	0.48 units Standard Deviation 3.8	1.5 units Standard Deviation 8.7

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU	20 Participants	12 Participants

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)	8 Participants	6 Participants

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Composite of Perioperative Complications	63 events	42 events

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Duration that patients required to be intubated

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Duration of Intubation	0.5 days Standard Deviation 1.1	0.7 days Standard Deviation 1.9

SECONDARY outcome

Timeframe: 2 days (average time of discharge from ICU)

Total number of days spent in intensive care unit (ICU)

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Length of Intensive Care Unit (ICU) Stay	2.0 days Interval 1.0 to 3.2	2.2 days Interval 1.4 to 3.9

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Total number of days spent in hospital

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Total Length of Hospital Stay	9 days Interval 6.0 to 12.0	7 days Interval 6.0 to 13.0

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of re-admissions to intensive care unit during the same hospital course.

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Intensive Care Unit (ICU) Readmission	14 readmissions	7 readmissions

SECONDARY outcome

Timeframe: 10 days (average time of discharge from the hospital)

Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Cerebrovascular Events	5 events	7 events

SECONDARY outcome

Timeframe: 30 days

Number of subjects readmitted to the hospital within 30 days (all-cause).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Subjects Readmitted to the Hospital	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 30 days

Number of subjects returning to the ER within 30 days (all-cause).

Outcome measures

Measure	Sitagliptin n=91 Participants Insulin glargine: Patients that required continuous insulin infusion (CII) at a rate \>1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Supplemental insulin (Insulin aspart): Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol.	Placebo n=91 Participants Placebo: One pill daily starting one day prior to surgery until discharge from the hospital.
Number of Subjects Returning to the ER Within 30 Days	61 Participants	57 Participants

Adverse Events

Sitagliptin

Serious events: 80 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 69 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Sitagliptin n=100 participants at risk Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.	Placebo n=101 participants at risk Placebo: One pill daily starting one day prior to surgery until discharge from the hospital
Cardiac disorders Miocardial Infarction	3.0% 3/100 • Number of events 3 • one month	2.0% 2/101 • Number of events 3 • one month
Cardiac disorders Cardiogenic shock	1.0% 1/100 • Number of events 1 • one month	0.00% 0/101 • one month
Cardiac disorders Atrial Fibrillation	27.0% 27/100 • Number of events 66 • one month	24.8% 25/101 • Number of events 50 • one month
Cardiac disorders Ventricular Fibrillation	2.0% 2/100 • Number of events 3 • one month	4.0% 4/101 • Number of events 5 • one month
Vascular disorders Stroke	5.0% 5/100 • Number of events 5 • one month	2.0% 2/101 • Number of events 7 • one month
Renal and urinary disorders Acute Kidney Injury	20.0% 20/100 • Number of events 57 • one month	15.8% 16/101 • Number of events 34 • one month
General disorders Re-admittion to ICU	7.0% 7/100 • Number of events 14 • one month	5.0% 5/101 • Number of events 7 • one month
General disorders Re-intubation	4.0% 4/100 • Number of events 6 • one month	2.0% 2/101 • Number of events 2 • one month
Vascular disorders Surgical Site Bleeding	1.0% 1/100 • Number of events 1 • one month	0.99% 1/101 • Number of events 1 • one month
Infections and infestations Readmission due to surgical site infection	3.0% 3/100 • Number of events 3 • one month	5.0% 5/101 • Number of events 5 • one month
General disorders Hospital readmissions for other reasons	7.0% 7/100 • Number of events 7 • one month	6.9% 7/101 • Number of events 7 • one month

Other adverse events

Measure	Sitagliptin n=100 participants at risk Sitagliptin: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.	Placebo n=101 participants at risk Placebo: One pill daily starting one day prior to surgery until discharge from the hospital
General disorders Headache	1.0% 1/100 • Number of events 1 • one month	0.99% 1/101 • Number of events 1 • one month
Gastrointestinal disorders Loss of appetite	1.0% 1/100 • Number of events 1 • one month	0.00% 0/101 • one month
Gastrointestinal disorders Nausea	1.0% 1/100 • Number of events 1 • one month	0.00% 0/101 • one month
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1 • one month	0.99% 1/101 • Number of events 1 • one month
Gastrointestinal disorders Diarrhea	0.00% 0/100 • one month	0.99% 1/101 • Number of events 1 • one month
Infections and infestations Infection	2.0% 2/100 • Number of events 2 • one month	2.0% 2/101 • Number of events 2 • one month

Additional Information

Dr. Guillermo Umpierrez

Emory University

Phone: 404-778-1665

Email: GEUMPIE@emory.edu

Results disclosure agreements

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