Phase 4
N=80
Sitagliptin in Non-Diabetic Patients Undergoing General Surgery
Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT02741687 ↗Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants Experiencing Stress Hyperglycemia — 7; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 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) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Stress Hyperglycemia |
7; 5 | — |
| SECONDARY Number of Patients Requiring Supplemental, Subcutaneous Insulin |
0; 1 | — |
| SECONDARY Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin |
5 | — |
| SECONDARY Length of Hospital Stay |
9; 11 | — |
| SECONDARY Number of Participants With Hypoglycemic Events |
2; 5; 0; 0 | — |
| SECONDARY Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization |
1; 2 | — |
| SECONDARY Number of Days in the ICU |
2.0; 1.5 | — |
| SECONDARY Number of Participants With Hospital Readmissions After Discharge |
0; 1 | — |
| SECONDARY Number of Participants With Emergency Room Visits After Discharge |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Complications |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
Eligibility Criteria
Inclusion Criteria
- Undergoing non-cardiac surgery
- No previous history of diabetes or hyperglycemia
- Fasting blood glucose level of 5 mg/day) or injectable corticosteroid
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Pregnancy or breast-feeding at time of enrollment
Data sourced from ClinicalTrials.gov (NCT02741687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.