Trial Outcomes & Findings for Sitagliptin in Non-Diabetic Patients Undergoing General Surgery (NCT NCT02741687)

NCT ID: NCT02741687

Last Updated: 2018-06-27

Results Overview

The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose \> 180 mg/dL.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 80 participants
• Primary outcome timeframe: Up to time of discharge from hospital, an average of 10 days
• Results posted on: 2018-06-27

Participant Flow

Participants were recruited from Emory University Hospital and Grady Hospital in Atlanta, Georgia between June 2016 and March 2017.

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.

Participant milestones

Measure	Placebo Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Overall Study STARTED	36	44
Overall Study COMPLETED	36	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

Baseline characteristics by cohort

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Total n=80 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 14.5 • n=5 Participants	51.1 years STANDARD_DEVIATION 12.8 • n=7 Participants	48.8 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	44 Participants n=7 Participants	80 Participants n=5 Participants
Surgery type Orthopedic	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Surgery type Genitourinary	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Surgery type Gastrointestinal	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Surgery type Neurologic	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Surgery type Oral maxillofacial surgery	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Surgery type Thoracic	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Surgery type Burn/Wound	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Surgery type Vascular	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Surgery type gynecologic	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
ASA Status ASA status = 1	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
ASA Status ASA status = 2	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
ASA Status ASA status = 3	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
ASA Status Unknown	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Admission blood glucose	98.5 mg/dl STANDARD_DEVIATION 20.0 • n=5 Participants	107.6 mg/dl STANDARD_DEVIATION 25.3 • n=7 Participants	103.6 mg/dl STANDARD_DEVIATION 23.4 • n=5 Participants

PRIMARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Participants Experiencing Stress Hyperglycemia	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Patients Requiring Supplemental, Subcutaneous Insulin	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

Population: The population for this analysis is limited to participants who received insulin during their hospital stay following surgery.

Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo

Outcome measures

Measure	Placebo Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=1 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin	—	5 international units of insulin

SECONDARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

Total length of hospital stay

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Length of Hospital Stay	9 days Interval 5.0 to 12.0	11 days Interval 7.0 to 14.0

SECONDARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

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)

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Participants With Hypoglycemic Events Clinically significant hypoglycemia	0 Participants	0 Participants
Number of Participants With Hypoglycemic Events Mild hypoglycemia	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery.

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to time of discharge from hospital, an average of 10 days

Population: This analysis includes participants who were transferred to the ICU following surgery.

The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required.

Outcome measures

Measure	Placebo n=1 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=2 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Days in the ICU	2.0 days Interval 2.0 to 2.0	1.5 days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

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.

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Participants With Hospital Readmissions After Discharge	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

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.

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Participants With Emergency Room Visits After Discharge	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 40 days (average time of discharge from the hospital plus 30 days)

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.

Outcome measures

Measure	Placebo n=36 Participants Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 Participants Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Number of Participants Experiencing Complications Wound infection	0 Participants	0 Participants
Number of Participants Experiencing Complications Respiratory failure	0 Participants	0 Participants
Number of Participants Experiencing Complications Pneumonia	0 Participants	0 Participants
Number of Participants Experiencing Complications Acute kidney injury	1 Participants	1 Participants
Number of Participants Experiencing Complications Cardiac event	0 Participants	0 Participants
Number of Participants Experiencing Complications Bacterial septic infection	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Sitagliptin

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=36 participants at risk Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 participants at risk Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	2.3% 1/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.8% 1/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	0.00% 0/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.

Other adverse events

Measure	Placebo n=36 participants at risk Participants received a placebo identical to sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)	Sitagliptin n=44 participants at risk Participants received sitagliptin beginning on the day before surgery and continuing daily during hospitalization (up to 10 days post surgery)
Gastrointestinal disorders Diarrhea	0.00% 0/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	2.3% 1/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Cardiac disorders Chest pain	0.00% 0/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	2.3% 1/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Vascular disorders Thrombosis	2.8% 1/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	0.00% 0/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Surgical and medical procedures Repeat operation	2.8% 1/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	4.5% 2/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Gastrointestinal disorders Ileus	2.8% 1/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	4.5% 2/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Gastrointestinal disorders Nausea	0.00% 0/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	2.3% 1/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Gastrointestinal disorders Vomiting	0.00% 0/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	4.5% 2/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Cardiac disorders Tachycardia with anemia	2.8% 1/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	0.00% 0/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.
Gastrointestinal disorders Abdominal pain	2.8% 1/36 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.	2.3% 1/44 • Adverse events were captured from the time a participants gave informed consent through 30 days after discharge from the hospital.

Additional Information

Maya Fayfman, MD

Emory University

Phone: 404-778-1664

Email: maya.fayfman@emory.edu

Results disclosure agreements

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