Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (SITACABG NonDM)

Emory University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Insulin glargine; Drug: Placebo; Drug: Supplemental insulin (Insulin aspart); Drug: Supplemental insulin (Insulin lispro); Drug: Regular Human Insulin; Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02443402

IRB00080209

Details and patient eligibility

About

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

Full description

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG \>180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.

Treatment:

Drug: Supplemental insulin (Insulin lispro)

Drug: Sitagliptin

Drug: Regular Human Insulin

Drug: Supplemental insulin (Insulin aspart)

Drug: Insulin glargine

Placebo

Placebo Comparator group

Description:

Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG \>180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.

Treatment:

Drug: Supplemental insulin (Insulin lispro)

Drug: Regular Human Insulin

Drug: Placebo

Drug: Supplemental insulin (Insulin aspart)

Drug: Insulin glargine