Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose
in response to surgery or illness). High glucose is linked to an increased risk of hospital
complications including 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. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4
inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with
low risk of hypoglycemia in general medicine and surgical patients.

Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat
patients with diabetes. The aim of this study is to determine whether treatment with
sitagliptin once daily can prevent the development of stress hyperglycemia during the
postoperative period in non-diabetic patients undergoing general surgery.

Inclusion Criteria:

- Undergoing non-cardiac surgery

- No previous history of diabetes or hyperglycemia

- Fasting blood glucose level of <126 mg/dl

- Blood glucose <126mg/dl at the time of randomization (could occur at any time of the
day)

Exclusion Criteria:

- History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater
than 6.5%) or previous treatment with oral antidiabetic agents or insulin

- Patients undergoing cardiac surgery

- Patients anticipated to require ICU care following surgery

- Severely impaired renal function (GFR < 30 ml/min) or clinically significant hepatic
failure

- Moribund patients and those at imminent risk of death (brain death or cardiac
standstill)

- Patients with gastrointestinal obstruction or adynamic ileus or those expected to
require gastrointestinal suction

- Patients with clinically relevant pancreatic or gallbladder disease

- Treatment with oral (> 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