Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Intervention: Sitagliptin; Placebo; Regular Human Insulin; Insulin glargine; Supplemental insulin (Insulin lispro); Supplemental insulin (Insulin aspart)
Intervention description: Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.; One pill daily starting one day prior to surgery until discharge from the hospital.; Continuous intravenous insulin given to intensive care unit (ICU) patients with a blood glucose (BG) greater than 180 mg/DL 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 is 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.; Patients that required continuous insulin infusion (CII) at a rate >1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Give 50% of calculated dose as basal (glargine/detemir) insulin every day. Basal insulin will be given approx. 4 hours before discontinuation of CII.
The total daily insulin dose will be adjusted as follow:
Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change Fasting and pre-meal BG between >180-240 mg/dl: increase basal dose by 10% every day Fasting and pre-meal BG >241 mg/dl: increase basal dose by 20% every day Fasting and pre-meal BG <100 mg/dl: stop basal; 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 blood glucose (BG) greater than 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 greater than 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 blood glucose (BG) greater than 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 greater than 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: Single (Participant)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Coronary artery bypass graft surgery (CABG); Type 2 Diabetes

Summary:

      The purpose of this study is to determine whether treatment with sitagliptin reduces the
      frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to
      determine whether treatment with sitagliptin is effective in maintaining blood sugar control
      in patients with type 2 diabetes (T2D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The ability to provide informed consent

          -  Ages 18 to 80 years old

          -  Male or female

          -  Scheduled to undergo cardiac surgery

          -  Type 2 Diabetes treated with diet, oral agents,

        Exclusion Criteria:

          -  Severely impaired kidney function (glomeruler filtration rate (GFR ) less than 30
             ml/min)

          -  Clinically significant liver failure

          -  Imminent risk of death (brain death or cardiac standstill)

          -  Gastrointestinal obstruction or adynamic ileus

          -  Expected to require gastrointestinal suction

          -  Clinically relevant pancreatic or gallbladder disease

          -  Using oral or injectable corticosteroid

          -  Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study

          -  Female subjects are pregnant or breast feeding at time of enrollment into the study