Hyperglycemia
Conditions
Keywords
Coronary artery bypass graft surgery (CABG), Type 2 Diabetes
Brief summary
The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (T2D).
Detailed description
The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) and the need for continuous intravenous insulin infusion (CII) in the intensive care unit (ICU) in patients with type 2 diabetes (T2D) undergoing coronary artery bypass graft (CABG) surgery. In addition, the study seeks to determine whether treatment with sitagliptin is effective in maintaining glycemic control and in preventing the need for subcutaneous (SC) insulin therapy in patients with T2D during the transition from intensive care unit (ICU) to regular floor in cardiac surgery patients with T2D.
Interventions
DRUGSitagliptin
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.
DRUGPlacebo
One pill daily starting one day prior to surgery until discharge from the hospital.
Continuous intravenous insulin given to intensive care unit (ICU) patients with a blood glucose (BG) greater than 180 mg/DL and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.Intravenous insulin infusion will be continued until the patient is able to eat and/or is transferred to non-ICU service. In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3 U/day.
DRUGInsulin 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) Give 50% of calculated dose as basal (glargine/detemir) insulin every day. Basal insulin will be given approx. 4 hours before discontinuation of CII. The total daily insulin dose will be adjusted as follow: Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change Fasting and pre-meal BG between \>180-240 mg/dl: increase basal dose by 10% every day Fasting and pre-meal BG \>241 mg/dl: increase basal dose by 20% every day Fasting and pre-meal BG \<100 mg/dl: stop basal
Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) greater than 240 mg/dL will be given. For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows: * BG between 181-220 mg/dL; 2-4 units of insulin lispro * BG between 221-260 mg/dL; 3-5 units of insulin lispro * BG between 261-300 mg/dL; 4-6 units of insulin lispro * BG between 301-350 mg/dL; 5-7 units of insulin lispro * BG between 351-400 mg/dL; 6-8 units of insulin lispro * BG greater than 400 mg/dL; 7-9 units of insulin lispro
Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) greater than 240 mg/dL will be given. For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows: * BG between 181-220 mg/dL; 2-4 units of insulin aspart * BG between 221-260 mg/dL; 3-5 units of insulin aspart * BG between 261-300 mg/dL; 4-6 units of insulin aspart * BG between 301-350 mg/dL; 5-7 units of insulin aspart * BG between 351-400 mg/dL; 6-8 units of insulin aspart * BG greater than 400 mg/dL; 7-9 units of insulin aspart
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The ability to provide informed consent * Ages 18 to 80 years old * Male or female * Scheduled to undergo cardiac surgery * Type 2 Diabetes treated with diet, oral agents,
Exclusion criteria
* Severely impaired kidney function (glomeruler filtration rate (GFR ) less than 30 ml/min) * Clinically significant liver failure * Imminent risk of death (brain death or cardiac standstill) * Gastrointestinal obstruction or adynamic ileus * Expected to require gastrointestinal suction * Clinically relevant pancreatic or gallbladder disease * Using oral or injectable corticosteroid * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * Female subjects are pregnant or breast feeding at time of enrollment into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) | 2 days (average time of discharge from ICU) | Number of patients with blood glucose (BG) levels greater than 180 mg/dl |
| Number of Patients With Persistent Hyperglycemia | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total IV Insulin in ICU | 2 days (average time of discharge from ICU) | Total IV insulin in ICU during recovery period. |
| Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery | 2 days (average time of discharge from ICU) | Mean insulin infusion dose per day of ICU patients during recovery period. |
| Duration of Continuous Intravenous Insulin Infusion (CII) | Up to 48 hours (average time of discharge from ICU) | Total hours of continuous intravenous insulin infusion (CII) |
| Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | 10 days (average time of discharge from the hospital) | Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII) |
| Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | Up to 14 days (time of discharge from the hospital) | Median number of days patients requiring SC insulin after discontinuation of CII |
| Mean Post-operative Blood Glucose (BG) Concentration | 10 days (average time of discharge from the hospital) | Mean post-operative blood glucose (BG) concentration during recovery period. |
| Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU) | 2 days (average time of discharge from ICU) | Total amount of SC insulin taken by ICU patients during recovery period. |
| Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours | 48 hours during recovery period | Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period. |
| Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU) | 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. |
| Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU | 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. |
| Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU) | 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). |
| Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII) | 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 |
| Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU) | 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). |
| Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU) | 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). |
| Composite of Perioperative Complications | 10 days (average time of discharge from the hospital) | Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction. |
| Duration of Intubation | 10 days (average time of discharge from the hospital) | Duration that patients required to be intubated |
| Length of Intensive Care Unit (ICU) Stay | 2 days (average time of discharge from ICU) | Total number of days spent in intensive care unit (ICU) |
| Total Length of Hospital Stay | 10 days (average time of discharge from the hospital) | Total number of days spent in hospital |
| Number of Intensive Care Unit (ICU) Readmission | 10 days (average time of discharge from the hospital) | Number of re-admissions to intensive care unit during the same hospital course. |
| Number of Cerebrovascular Events | 10 days (average time of discharge from the hospital) | Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit |
| Number of Subjects Readmitted to the Hospital | 30 days | Number of subjects readmitted to the hospital within 30 days (all-cause). |
| Number of Subjects Returning to the ER Within 30 Days | 30 days | Number of subjects returning to the ER within 30 days (all-cause). |
| Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU) | 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). |
| Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU) | 2 days (average time of discharge from ICU) | Mean blood glucose (BG) concentration of ICU patients during recovery period. |
Countries
United States
Participant flow
Pre-assignment details
One participant died during hospital admission before receiving study medication.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 100 |
| Placebo Placebo: One pill daily starting one day prior to surgery until discharge from the hospital. | 101 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 5 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Sitagliptin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 9.1 | 63.8 years STANDARD_DEVIATION 8.5 | 63.3 years STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 48 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 72 Participants | 146 Participants | 74 Participants |
| Region of Enrollment United States | 100 participants | 201 participants | 101 participants |
| Sex: Female, Male Female | 23 Participants | 53 Participants | 30 Participants |
| Sex: Female, Male Male | 77 Participants | 148 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 1 / 101 |
| other Total, other adverse events | 6 / 100 | 5 / 101 |
| serious Total, serious adverse events | 80 / 100 | 69 / 101 |
Outcome results
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
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) | 76 Participants |
| Placebo | Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) | 68 Participants |
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).
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients With Persistent Hyperglycemia | 58 Participants |
| Placebo | Number of Patients With Persistent Hyperglycemia | 59 Participants |
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.
Time frame: 48 hours during recovery period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours | 0.48 units | Standard Deviation 3.8 |
| Placebo | Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours | 1.5 units | Standard Deviation 8.7 |
Secondary
Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
Total amount of SC insulin taken by ICU patients during recovery period.
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU) | 1.0 units | Standard Deviation 6.4 |
| Placebo | Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU) | 2.2 units | Standard Deviation 13.1 |
Secondary
Composite of Perioperative Complications
Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Composite of Perioperative Complications | 63 events |
| Placebo | Composite of Perioperative Complications | 42 events |
Secondary
Duration of Continuous Intravenous Insulin Infusion (CII)
Total hours of continuous intravenous insulin infusion (CII)
Time frame: Up to 48 hours (average time of discharge from ICU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Duration of Continuous Intravenous Insulin Infusion (CII) | 27.7 hours | Standard Deviation 27.6 |
| Placebo | Duration of Continuous Intravenous Insulin Infusion (CII) | 27.7 hours | Standard Deviation 28 |
Secondary
Duration of Intubation
Duration that patients required to be intubated
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Duration of Intubation | 0.5 days | Standard Deviation 1.1 |
| Placebo | Duration of Intubation | 0.7 days | Standard Deviation 1.9 |
Secondary
Length of Intensive Care Unit (ICU) Stay
Total number of days spent in intensive care unit (ICU)
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sitagliptin | Length of Intensive Care Unit (ICU) Stay | 2.0 days |
| Placebo | Length of Intensive Care Unit (ICU) Stay | 2.2 days |
Secondary
Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
Mean blood glucose (BG) concentration of ICU patients during recovery period.
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU) | 148.7 mmol/L | Standard Deviation 15.8 |
| Placebo | Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU) | 149.8 mmol/L | Standard Deviation 16 |
Secondary
Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
Mean insulin infusion dose per day of ICU patients during recovery period.
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery | 45.9 unit/day | Standard Deviation 36.1 |
| Placebo | Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery | 46.4 unit/day | Standard Deviation 36 |
Secondary
Mean Post-operative Blood Glucose (BG) Concentration
Mean post-operative blood glucose (BG) concentration during recovery period.
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Mean Post-operative Blood Glucose (BG) Concentration | 154.2 mmol/L | Standard Deviation 29 |
| Placebo | Mean Post-operative Blood Glucose (BG) Concentration | 156.5 mmol/L | Standard Deviation 36.1 |
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
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sitagliptin | Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | 4 days |
| Placebo | Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | 4 days |
Secondary
Number of Cerebrovascular Events
Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Number of Cerebrovascular Events | 5 events |
| Placebo | Number of Cerebrovascular Events | 7 events |
Secondary
Number of Intensive Care Unit (ICU) Readmission
Number of re-admissions to intensive care unit during the same hospital course.
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Number of Intensive Care Unit (ICU) Readmission | 14 readmissions |
| Placebo | Number of Intensive Care Unit (ICU) Readmission | 7 readmissions |
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
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII) | 86 Participants |
| Placebo | Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII) | 85 Participants |
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)
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | 74 Participants |
| Placebo | Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII) | 78 Participants |
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).
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU) | 8 Participants |
| Placebo | Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU) | 6 Participants |
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).
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU) | 8 Participants |
| Placebo | Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU) | 8 Participants |
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).
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU) | 0 Participants |
| Placebo | Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU) | 0 Participants |
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).
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU) | 0 Participants |
| Placebo | Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU) | 0 Participants |
Secondary
Number of Subjects Readmitted to the Hospital
Number of subjects readmitted to the hospital within 30 days (all-cause).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Subjects Readmitted to the Hospital | 10 Participants |
| Placebo | Number of Subjects Readmitted to the Hospital | 12 Participants |
Secondary
Number of Subjects Returning to the ER Within 30 Days
Number of subjects returning to the ER within 30 days (all-cause).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Subjects Returning to the ER Within 30 Days | 61 Participants |
| Placebo | Number of Subjects Returning to the ER Within 30 Days | 57 Participants |
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.
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU | 20 Participants |
| Placebo | Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU | 12 Participants |
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.
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sitagliptin | Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU) | 5 Participants |
| Placebo | Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU) | 3 Participants |
Secondary
Total IV Insulin in ICU
Total IV insulin in ICU during recovery period.
Time frame: 2 days (average time of discharge from ICU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Total IV Insulin in ICU | 100.43 units | Standard Deviation 123.44 |
| Placebo | Total IV Insulin in ICU | 95.68 units | Standard Deviation 118.32 |
Secondary
Total Length of Hospital Stay
Total number of days spent in hospital
Time frame: 10 days (average time of discharge from the hospital)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sitagliptin | Total Length of Hospital Stay | 9 days |
| Placebo | Total Length of Hospital Stay | 7 days |