Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery

Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery

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

About 80% of patients develop high glucose after cardiac surgery. High glucose is linked to an increased risk of hospital complications. High glucose increases the risk of wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. This study will determine if sitagliptin can prevent the development of high glucose after heart surgery. Sitagliptin is a diabetes pill approved by the Food and Drug Administration (FDA) to treat patients with diabetes.

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