Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Sitagliptin; Placebo; Regular Human Insulin; Insulin glargine; Supplemental insulin (Insulin lispro); Supplemental insulin (Insulin aspart)
Intervention description: 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
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Sitagliptin Phosphate; Insulin Aspart; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Non diabetic hyperglycemia

Summary:

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

Eligibility criteria:

        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