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

NCT02443402 Phase 4 COMPLETED Results posted

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

Details

Lead sponsor	Emory University
Phase	Phase 4
Status	COMPLETED
Enrolment	68
Start date	2016-01
Completion	2016-12

Conditions

• Coronary Artery Disease

Interventions

• Sitagliptin
• Placebo
• Regular Human Insulin
• Insulin glargine
• Supplemental insulin (Insulin lispro)
• Supplemental insulin (Insulin aspart)

Primary outcomes

• Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU) — Post-Surgery (Up to 4 Days)
  Number of participants who developed stress hyperglycemia (BG \>180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.
• Number of Subjects With Persistent Hyperglycemia — Post-Surgery (Up to 10 Days)
  Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG \> 180 mg/dL, or with average daily BG \>180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)

Countries

United States