Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients
Condition: Poor Glycemic Control
Intervention: Metformin; Glargine insulin; Glulisine
Intervention description: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.
Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.
Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin.; Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.
Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.
Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.; Glulisine is an injectable, recombinant insulin analog. The total daily dose varies between 0.5 to 1 unit/kg/day depending on the levels of blood glucose. Glulisine will be given within 15 minutes before a meal or within 20 minutes after starting a meal.
Intervention MeSH terms: Metformin; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass Graft surgery

Summary:

      Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they
      are in the hospital. No studies have shown what the best insulin regimen is for CABG patients
      with type 2 diabetes is after going home from the hospital. Patients with high blood sugar
      and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well
      their treatment(s) for diabetes work after discharge. Patients with diabetes will be
      discharged on oral antidiabetic drugs or with insulin glargine injections based on their
      sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the average
      blood sugar level in the body over 3 months) will be discharged on the same diabetes
      medications that they used before coming to the hospital. Those with an HbA1c between 7% and
      9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and
      oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100%
      of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin
      glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12
      weeks after discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 80 years undergoing primary coronary
             artery bypass graft surgery (CABG).

          2. Post surgical hyperglycemia (Blood glucose >140 mg/dl)

          3. Patients with and without a history of type 2 diabetes

        Exclusion Criteria:

          1. Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or a
             glomerular filtration rate < 30 ml/min) or clinically significant hepatic failure.

          2. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and
             hyperosmolar hyperglycemic states.

          3. Moribund patients and those at imminent risk of death (brain death or cardiac
             standstill).

          4. Patients or next-to-kin with mental conditions rendering the subject or family member
             unable to understand the nature, scope, and possible consequences of the study.

          5. Female subjects who are pregnant or breast-feeding at time of enrollment into the
             study.