| Primary | Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) | Number of patients with blood glucose (BG) levels greater than 180 mg/dl | | Posted | | Count of Participants | | Participants | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | Sitagliptin | 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. | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Primary | Number of Patients With Persistent Hyperglycemia | 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). | | Posted | | Count of Participants | | Participants | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII) | Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl | | Posted | | Count of Participants | | Participants | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU) | Mean blood glucose (BG) concentration of ICU patients during recovery period. | | Posted | | Mean | Standard Deviation | mmol/L | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Total IV Insulin in ICU | Total IV insulin in ICU during recovery period. | | Posted | | Mean | Standard Deviation | units | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery | Mean insulin infusion dose per day of ICU patients during recovery period. | | Posted | | Mean | Standard Deviation | unit/day | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Duration of Continuous Intravenous Insulin Infusion (CII) | Total hours of continuous intravenous insulin infusion (CII) | | Posted | | Mean | Standard Deviation | hours | | Up to 48 hours (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII) | Some patients were not transitioned to SQ insulin because they stayed on CII due to complications, these patients were taken off the analysis | Posted | | Count of Participants | | Participants | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | Median number of days patients requiring SC insulin after discontinuation of CII | Some patients were not transitioned to SQ insulin because they stayed on CII due to complications, these patients were taken off the analysis | Posted | | Median | Inter-Quartile Range | days | | Up to 14 days (time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Mean Post-operative Blood Glucose (BG) Concentration | Mean post-operative blood glucose (BG) concentration during recovery period. | | Posted | | Mean | Standard Deviation | mmol/L | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU) | Total amount of SC insulin taken by ICU patients during recovery period. | | Posted | | Mean | Standard Deviation | units | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours | Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period. | | Posted | | Mean | Standard Deviation | units | | 48 hours during recovery period | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU) | Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period. | | Posted | | Count of Participants | | Participants | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU | Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period. | | Posted | | Count of Participants | | Participants | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU) | Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU). | | Posted | | Count of Participants | | Participants | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU) | Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU). | | Posted | | Count of Participants | | Participants | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU) | Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU). | | Posted | | Count of Participants | | Participants | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU) | Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU). | | Posted | | Count of Participants | | Participants | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Composite of Perioperative Complications | Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction. | | Posted | | Number | | events | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Duration of Intubation | Duration that patients required to be intubated | | Posted | | Mean | Standard Deviation | days | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Length of Intensive Care Unit (ICU) Stay | Total number of days spent in intensive care unit (ICU) | | Posted | | Median | Inter-Quartile Range | days | | 2 days (average time of discharge from ICU) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Total Length of Hospital Stay | Total number of days spent in hospital | | Posted | | Median | Inter-Quartile Range | days | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Intensive Care Unit (ICU) Readmission | Number of re-admissions to intensive care unit during the same hospital course. | | Posted | | Number | | readmissions | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Cerebrovascular Events | Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit | | Posted | | Number | | events | | 10 days (average time of discharge from the hospital) | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Subjects Readmitted to the Hospital | Number of subjects readmitted to the hospital within 30 days (all-cause). | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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| Secondary | Number of Subjects Returning to the ER Within 30 Days | Number of subjects returning to the ER within 30 days (all-cause). | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | Placebo | Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. |
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