Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

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

Detailed 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.
    

Intervention name(s): Sitagliptin; Placebo; Regular Human Insulin; Insulin glargine; Supplemental insulin (Insulin lispro); Supplemental insulin (Insulin aspart)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will take one pill daily until the day prior to them being discharged from the hospital. Sitagliptin will be dispensed orally at 100 mg/day and at a lower dose 50 mg for patients with glomerular filtration rate (GFR) < 30-50. If the calculated GFR drops to 30 mL/min/1.73m2 or below, patients will receive study medication 25mg daily; One pill daily until discharge; Continuous intravenous insulin given to ICU patients with a BG > 180 mg/DL for two consecutive readings and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Intravenous insulin infusion will be continued until the patient is able to eat and/or transferred to non-ICU service. In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3 U/day.; When regular insulin is discontinued, if needed, insulin glargine will be given once daily. Patients who required continuous insulin infusion at an average rate >2U/h will be transitioned to basal (to be given approx. 4 hours prior to discontinuing the insulin drip) starting at a dose 0.2 U/Kg/d.
Subjects with a BG at 140-200 mg/dL will start glargine at 0.2 U/kg weight per day. And subjects with BG between 201-400 mg/dL will start glargine at 0.2 U/Kg/day
The basal insulin dose will be adjusted as follow:
If fasting and pre-dinner BG is between 100 - 180 mg/dL in the absence of hypoglycemia the previous day: no change
If fasting and pre-dinner BG is between 180 - 240 mg/dL in the absence of hypoglycemia: increase glargine by 10% every day
If fasting and pre-dinner BG is > 241 mg/dL in the absence of hypoglycemia the previous day: increase glargine dose by 20% every day
If fasting and pre-dinner BG is < 100 mg/dL in the absence of hypoglycemia: stop glargine; Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given.
For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
BG between 181-220 mg/dL; 2-4 units of insulin lispro
BG between 221-260 mg/dL; 3-5 units of insulin lispro
BG between 261-300 mg/dL; 4-6 units of insulin lispro
BG between 301-350 mg/dL; 5-7 units of insulin lispro
BG between 351-400 mg/dL; 6-8 units of insulin lispro
BG > 400 mg/dL; 7-9 units of insulin lispro; Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given.
For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
BG between 181-220 mg/dL; 2-4 units of insulin aspart
BG between 221-260 mg/dL; 3-5 units of insulin aspart
BG between 261-300 mg/dL; 4-6 units of insulin aspart
BG between 301-350 mg/dL; 5-7 units of insulin aspart
BG between 351-400 mg/dL; 6-8 units of insulin aspart
BG > 400 mg/dL; 7-9 units of insulin aspart
Other intervention name(s): Januvia; Novolin-R, Humulin-R; Lantus (glargine); Humalog; Novolog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Sitagliptin Phosphate; Insulin Aspart; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Non diabetic hyperglycemia