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Trial record 11 of 35 for:    "Hyperglycemia" | "Insulin Aspart"

Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

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ClinicalTrials.gov Identifier: NCT02741687
Recruitment Status : Completed
First Posted : April 18, 2016
Results First Posted : June 27, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Maya Fayfman, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Hyperglycemia
Interventions Drug: Sitagliptin
Drug: Placebo
Drug: Supplemental insulin (insulin lispro)
Drug: Supplemental insulin (insulin aspart)
Drug: Long acting basal insulin (insulin detemir)
Drug: Long acting basal insulin (insulin glargine)
Enrollment 80
Recruitment Details Participants were recruited from Emory University Hospital and Grady Hospital in Atlanta, Georgia between June 2016 and March 2017.
Pre-assignment Details A total of 97 patients consented to be in the study and one participant withdrew prior to randomization. After subsequent failure to meet eligibility criteria (such as surgery being cancelled or postponed) and voluntary participant withdrawals prior to receiving the study medication there were 80 participants who received the study intervention.
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Period Title: Overall Study
Started 36 44
Completed 36 44
Not Completed 0 0
Arm/Group Title Placebo Sitagliptin Total
Hide Arm/Group Description Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) Total of all reporting groups
Overall Number of Baseline Participants 36 44 80
Hide Baseline Analysis Population Description
The baseline analysis population includes all participants who began the intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 44 participants 80 participants
45.9  (14.5) 51.1  (12.8) 48.8  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 44 participants 80 participants
Female
18
  50.0%
19
  43.2%
37
  46.3%
Male
18
  50.0%
25
  56.8%
43
  53.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 36 participants 44 participants 80 participants
Black
26
  72.2%
32
  72.7%
58
  72.5%
White
8
  22.2%
11
  25.0%
19
  23.8%
Other
2
   5.6%
1
   2.3%
3
   3.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants 44 participants 80 participants
36
 100.0%
44
 100.0%
80
 100.0%
Surgery type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 44 participants 80 participants
Orthopedic
6
  16.7%
11
  25.0%
17
  21.3%
Genitourinary
9
  25.0%
14
  31.8%
23
  28.7%
Gastrointestinal
3
   8.3%
3
   6.8%
6
   7.5%
Neurologic
4
  11.1%
5
  11.4%
9
  11.3%
Oral maxillofacial surgery
4
  11.1%
1
   2.3%
5
   6.3%
Thoracic
2
   5.6%
2
   4.5%
4
   5.0%
Burn/Wound
1
   2.8%
4
   9.1%
5
   6.3%
Vascular
0
   0.0%
1
   2.3%
1
   1.3%
gynecologic
7
  19.4%
3
   6.8%
10
  12.5%
ASA Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 44 participants 80 participants
ASA status = 1
4
  11.1%
4
   9.1%
8
  10.0%
ASA status = 2
17
  47.2%
22
  50.0%
39
  48.8%
ASA status = 3
9
  25.0%
13
  29.5%
22
  27.5%
Unknown
6
  16.7%
5
  11.4%
11
  13.8%
[1]
Measure Description:

The American Society of Anesthesiology (ASA) Physical Status Classification is a method of assessing patients prior to surgery. The following categories are used:

  1. = Healthy person
  2. = Mild systemic disease
  3. = Severe systemic disease
  4. = Severe systemic disease that is a constant threat to life
  5. = A moribund person who is not expected to survive with the operation
  6. = A declared brain-dead person whose organs are being removed for donor purposes
Admission blood glucose  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 36 participants 44 participants 80 participants
98.5  (20.0) 107.6  (25.3) 103.6  (23.4)
1.Primary Outcome
Title Number of Participants Experiencing Stress Hyperglycemia
Hide Description The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
7
  19.4%
5
  11.4%
2.Secondary Outcome
Title Number of Patients Requiring Supplemental, Subcutaneous Insulin
Hide Description Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.3%
3.Secondary Outcome
Title Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin
Hide Description Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
The population for this analysis is limited to participants who received insulin during their hospital stay following surgery.
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: international units of insulin
5
4.Secondary Outcome
Title Length of Hospital Stay
Hide Description Total length of hospital stay
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Median (Inter-Quartile Range)
Unit of Measure: days
9
(5 to 12)
11
(7 to 14)
5.Secondary Outcome
Title Number of Participants With Hypoglycemic Events
Hide Description Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL)
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
Mild hypoglycemia
2
   5.6%
5
  11.4%
Clinically significant hypoglycemia
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization
Hide Description The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery.
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.8%
2
   4.5%
7.Secondary Outcome
Title Number of Days in the ICU
Hide Description The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required.
Time Frame Up to time of discharge from hospital, an average of 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes participants who were transferred to the ICU following surgery.
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 1 2
Median (Inter-Quartile Range)
Unit of Measure: days
2.0
(2.0 to 2.0)
1.5
(1.0 to 2.0)
8.Secondary Outcome
Title Number of Participants With Hospital Readmissions After Discharge
Hide Description Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known.
Time Frame Up to 40 days (average time of discharge from the hospital plus 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.3%
9.Secondary Outcome
Title Number of Participants With Emergency Room Visits After Discharge
Hide Description Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known.
Time Frame Up to 40 days (average time of discharge from the hospital plus 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants Experiencing Complications
Hide Description The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented.
Time Frame Up to 40 days (average time of discharge from the hospital plus 30 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description:
Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Number of Participants Analyzed 36 44
Measure Type: Count of Participants
Unit of Measure: Participants
Wound infection
0
   0.0%
0
   0.0%
Respiratory failure
0
   0.0%
0
   0.0%
Pneumonia
0
   0.0%
0
   0.0%
Acute kidney injury
1
   2.8%
1
   2.3%
Cardiac event
0
   0.0%
0
   0.0%
Bacterial septic infection
0
   0.0%
0
   0.0%
Time Frame Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sitagliptin
Hide Arm/Group Description Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery) Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
All-Cause Mortality
Placebo Sitagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/44 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sitagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/36 (2.78%)   1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism *  0/36 (0.00%)  1/44 (2.27%) 
Bronchospasm * [1]  1/36 (2.78%)  0/44 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Due to anesthesia medication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Sitagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   5/36 (13.89%)   8/44 (18.18%) 
Cardiac disorders     
Chest pain *  0/36 (0.00%)  1/44 (2.27%) 
Tachycardia with anemia *  1/36 (2.78%)  0/44 (0.00%) 
Gastrointestinal disorders     
Ileus *  1/36 (2.78%)  2/44 (4.55%) 
Nausea *  0/36 (0.00%)  1/44 (2.27%) 
Vomiting *  0/36 (0.00%)  2/44 (4.55%) 
Diarrhea *  0/36 (0.00%)  1/44 (2.27%) 
Abdominal pain *  1/36 (2.78%)  1/44 (2.27%) 
Surgical and medical procedures     
Repeat operation *  1/36 (2.78%)  2/44 (4.55%) 
Vascular disorders     
Thrombosis *  1/36 (2.78%)  0/44 (0.00%) 
*
Indicates events were collected by non-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: Maya Fayfman, MD
Organization: Emory University
Phone: 404-778-1664
EMail: maya.fayfman@emory.edu
Layout table for additonal information
Responsible Party: Maya Fayfman, Emory University
ClinicalTrials.gov Identifier: NCT02741687     History of Changes
Other Study ID Numbers: IRB00087357
First Submitted: April 13, 2016
First Posted: April 18, 2016
Results First Submitted: April 30, 2018
Results First Posted: June 27, 2018
Last Update Posted: June 27, 2018