Phase 4
N=67
Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02443402 ↗Enrolled (actual)
67
Serious AEs
26.7%
Results posted
Feb 2018
Primary outcome: Primary: Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU) — 22; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug); Placebo (Drug); Regular Human Insulin (Drug); Insulin glargine (Drug); Supplemental insulin (Insulin lispro) (Drug); Supplemental insulin (Insulin aspart) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU) |
22; 25 | — |
| PRIMARY Number of Subjects With Persistent Hyperglycemia |
7; 6 | — |
| SECONDARY Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia |
7; 7 | — |
| SECONDARY Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration |
137; 138 | — |
| SECONDARY Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU) |
37; 83 | — |
| SECONDARY Duration of Continuous Intravenous Insulin (CII) |
12; 17 | — |
| SECONDARY Mean Units Subcutaneous (SQ) Insulin Required |
2.4; 2.4 | — |
| SECONDARY Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU) |
123; 124 | — |
| SECONDARY Total Insulin Therapy in the Intensive Care Unit (ICU) |
0; 0 | — |
| SECONDARY Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII) |
7; 6 | — |
| SECONDARY Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU) |
8; 8 | — |
| SECONDARY Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay |
2; 1 | — |
| SECONDARY Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU) |
1; 0 | — |
| SECONDARY Number of Participants With Blood Glucose Less Than 40 mg/dl |
0; 0 | — |
| SECONDARY Hospital Mortality Rate |
0; 0 | — |
| SECONDARY Intensive Care Unit (ICU) Mortality Rate |
0; 0 | — |
| SECONDARY Number of Participants With Cerebrovascular Events |
2; 1 | — |
| SECONDARY Hospital Complication Rate |
47; 57 | — |
| SECONDARY Length of Stay: Intensive Care Unit (ICU) |
2; 2 | — |
| SECONDARY Length of Hospital Stay After Study Randomization |
6.0; 6.5 | — |
| SECONDARY Number of Participants Re-admitted to the Hospital Due to Wound Infections |
1; 1 | — |
| SECONDARY Number of Participants Re-admitted to the Hospital Not Due to Wound Infections |
3; 0 | — |
| SECONDARY Number of Participants With Emergency Room (ER) Visits |
2; 1 | — |
| SECONDARY Number of Participants With Infections Not Requiring Hospital Re-admission |
0; 1 | — |
| SECONDARY Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours |
11; 7 | — |
| SECONDARY Number of Subjects Requiring Re-intubation |
1; 2 | — |
| SECONDARY Number of Subjects Requiring Re-intubation Within 24 Hours |
2; 1 | — |
| SECONDARY Number of Subject Requiring Surgical Re-Intervention |
1; 2 | — |
Summary
The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
- No previous history of diabetes
- No previous history of hyperglycemia
Exclusion Criteria
- Patients with hyperglycemia (blood glucose > 125 mg/dL); or glycated hemoglobin (HbA1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin
- Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR < 30 mL/min) or clinically significant hepatic failure
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
- Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction
- Patients with clinically relevant pancreatic or gallbladder disease
- Treatment with oral or injectable corticosteroid
- Mental condition rendering the subject unable to understand the scope, and consequences of the study
- Female subjects who are pregnant or breast feeding at time of enrollment into the study
Data sourced from ClinicalTrials.gov (NCT02443402). 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.