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Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (SITACABG NonDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443402
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Coronary Artery Disease
Interventions Drug: Sitagliptin
Drug: Placebo
Drug: Regular Human Insulin
Drug: Insulin glargine
Drug: Supplemental insulin (Insulin lispro)
Drug: Supplemental insulin (Insulin aspart)
Enrollment 68
Recruitment Details Participants were recruited from four academic hospitals including Emory University Hospital, Emory Midtown Hospital, Emory Saint Joseph’s, and Grady Memorial Hospital in Atlanta, Georgia between January 2016 and October 2016.
Pre-assignment Details Of the 68 participants consented for study participation, seven did not begin study participation after randomization. One participant was a screen failure prior to randomization. All participants that began a study intervention were included in the baseline analysis.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin. Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Period Title: Overall Study
Started 36 31
Completed 32 28
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             3             1
Screen Failure             1             2
Arm/Group Title Sitagliptin Placebo Total
Hide Arm/Group Description Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin. Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo. Total of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
The participants included in the baseline analysis were randomized to a study arm and received an intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
64  (11) 64  (9) 64  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
8
  25.0%
5
  17.9%
13
  21.7%
Male
24
  75.0%
23
  82.1%
47
  78.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Caucasian
20
  62.5%
20
  71.4%
40
  66.7%
African American
9
  28.1%
6
  21.4%
15
  25.0%
Other
3
   9.4%
2
   7.1%
5
   8.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 32 participants 28 participants 60 participants
32
 100.0%
28
 100.0%
60
 100.0%
1.Primary Outcome
Title Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
Hide Description Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
22
  68.8%
25
  89.3%
2.Primary Outcome
Title Number of Subjects With Persistent Hyperglycemia
Hide Description Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)
Time Frame Post-Surgery (Up to 10 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
7
  21.9%
6
  21.4%
3.Secondary Outcome
Title Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
Hide Description Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
7
  21.9%
7
  25.0%
4.Secondary Outcome
Title Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
Hide Description The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: mg/dL
137  (16) 138  (25)
5.Secondary Outcome
Title Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
Hide Description The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: units per day
37  (60) 83  (64)
6.Secondary Outcome
Title Duration of Continuous Intravenous Insulin (CII)
Hide Description Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.
Time Frame Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Inter-Quartile Range)
Unit of Measure: hours
12
(5 to 88)
17
(9 to 80)
7.Secondary Outcome
Title Mean Units Subcutaneous (SQ) Insulin Required
Hide Description Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).
Time Frame Post-Surgery (Up to 10 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: units
2.4  (.5) 2.4  (.9)
8.Secondary Outcome
Title Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
Hide Description The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: mg/dl
123  (13) 124  (16)
9.Secondary Outcome
Title Total Insulin Therapy in the Intensive Care Unit (ICU)
Hide Description Total amount of insulin glargine insulin (units) administered in the ICU per day.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Standard Deviation)
Unit of Measure: units per day
0  (0) 0  (0)
10.Secondary Outcome
Title Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
Hide Description Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
7
  21.9%
6
  21.4%
11.Secondary Outcome
Title Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
Hide Description Number of participants with blood glucose (BG) >180 after transition from ICU.
Time Frame Post-Surgery (Up to 10 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
8
  25.0%
8
  28.6%
12.Secondary Outcome
Title Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
Hide Description Number of participants with blood glucose (BG) <70 during ICU stay.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.3%
1
   3.6%
13.Secondary Outcome
Title Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
Hide Description Number of participants with blood glucose (BG) <70 after transition from ICU.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.1%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Blood Glucose Less Than 40 mg/dl
Hide Description Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.
Time Frame Duration of Hospitalization (Up to 30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Hospital Mortality Rate
Hide Description The total number of subject deaths during hospital stay will be recorded.
Time Frame Post-Surgery (Up to 10 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Intensive Care Unit (ICU) Mortality Rate
Hide Description The total number of subject deaths during ICU stay will be recorded.
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Cerebrovascular Events
Hide Description Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.
Time Frame Post-Hospital Discharge (Up to 10 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.3%
1
   3.6%
18.Secondary Outcome
Title Hospital Complication Rate
Hide Description The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.
Time Frame Duration of Hospitalization (Up to 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Number
Unit of Measure: number of complications
47 57
19.Secondary Outcome
Title Length of Stay: Intensive Care Unit (ICU)
Hide Description Number of days in the ICU after coronary artery bypass graft surgery (CABG).
Time Frame Post-Surgery (Up to 4 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Inter-Quartile Range)
Unit of Measure: days
2
(1 to 4)
2
(1 to 3)
20.Secondary Outcome
Title Length of Hospital Stay After Study Randomization
Hide Description Number of days in the hospital after a participant is randomized to a study intervention.
Time Frame Post-Randomization (Up to 9 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Mean (Inter-Quartile Range)
Unit of Measure: days
6.0
(5.0 to 9.0)
6.5
(4.5 to 8.0)
21.Secondary Outcome
Title Number of Participants Re-admitted to the Hospital Due to Wound Infections
Hide Description Number of subjects readmitted to the hospital within 30 days due to wound infection.
Time Frame Post-Hospital Discharge (Up to 30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.1%
1
   3.6%
22.Secondary Outcome
Title Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
Hide Description Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.
Time Frame Post-Hospital Discharge (Up to 30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.4%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Emergency Room (ER) Visits
Hide Description Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.
Time Frame Post-Hospital Discharge (Up to 30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.3%
1
   3.6%
24.Secondary Outcome
Title Number of Participants With Infections Not Requiring Hospital Re-admission
Hide Description Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.
Time Frame Post-Hospital Discharge (Up to 30 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   3.6%
25.Secondary Outcome
Title Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
Hide Description The number of subjects requiring the use of inotropes for >24 hours post CABG.
Time Frame Post-Surgery (Up to 2 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
11
  34.4%
7
  25.0%
26.Secondary Outcome
Title Number of Subjects Requiring Re-intubation
Hide Description The number of subjects requiring re-intubation after CABG.
Time Frame Post-Surgery (Up to 2 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.1%
2
   7.1%
27.Secondary Outcome
Title Number of Subjects Requiring Re-intubation Within 24 Hours
Hide Description The number of subjects requiring re-intubation with 24 after CABG.
Time Frame Post-Surgery (Up to 24 Hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.3%
1
   3.6%
28.Secondary Outcome
Title Number of Subject Requiring Surgical Re-Intervention
Hide Description The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.
Time Frame Post-Surgery (Up to 10 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study assessments.
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin.
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
Overall Number of Participants Analyzed 32 28
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.1%
2
   7.1%
Time Frame Adverse events were collected through hospital discharge (up to 30 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take sitagliptin. Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) were randomized to take a placebo.
All-Cause Mortality
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/32 (28.13%)      7/28 (25.00%)    
Injury, poisoning and procedural complications     
Surgical Site Bleeding   2/32 (6.25%)  2 2/28 (7.14%)  2
Nervous system disorders     
Stroke   2/32 (6.25%)  2 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Edema   4/32 (12.50%)  4 4/28 (14.29%)  4
Vascular disorders     
Deep Vein Thrombosis   1/32 (3.13%)  1 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sitagliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/32 (68.75%)      15/28 (53.57%)    
Cardiac disorders     
Atrial Fibrillation   10/32 (31.25%)  10 9/28 (32.14%)  9
Ventricular Fibrillation   1/32 (3.13%)  1 0/28 (0.00%)  0
Heart Failure   2/32 (6.25%)  2 2/28 (7.14%)  2
Infections and infestations     
Pneumonia   3/32 (9.38%)  3 1/28 (3.57%)  1
Urinary Tract Infection   1/32 (3.13%)  1 1/28 (3.57%)  1
Renal and urinary disorders     
Acute Kidney Injury   5/32 (15.63%)  5 2/28 (7.14%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
Phone: 404-778-1665
EMail: geumpie@emory.edu
Layout table for additonal information
Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT02443402     History of Changes
Other Study ID Numbers: IRB00080209
First Submitted: May 11, 2015
First Posted: May 13, 2015
Results First Submitted: December 1, 2017
Results First Posted: February 6, 2018
Last Update Posted: February 6, 2018