Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting; Polystyrene sulfonic acid; Sitagliptin Phosphate

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