Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients
Condition: Poor Glycemic Control
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Hospital discharge represents a critical time for ensuring a safe transition to the
      outpatient setting and reducing the need for emergency department visits and
      re-hospitalization. Poor coordination of patient care and education on insulin administration
      at the time of patient discharge to home may be associated with medical errors that may
      increase risk of hypoglycemia, hyperglycemia and hospital readmission. No prospective studies
      have examined the impact of a discharge treatment regimen after cardiac surgery. Therefore,
      this study aims to determine the efficacy and safety of an HbA1c based treatment algorithm in
      controlling blood glucose (BG) after discharge. The total duration of the study is 3 months.

      This study will include diabetic and non-diabetic subjects who participated in the American
      Diabetes Association (ADA) trial entitled "Intensive Insulin Therapy in Patients Undergoing
      Coronary Artery Bypass Surgery." The ADA study is a two-arm randomized multicenter,
      open-label controlled trial aimed to determine if intensive insulin control with a BG target
      of 100-140mg/dl will reduce perioperative complications compared to a conventional BG control
      with a target of 141-180 mg/dl in hyperglycemic subjects who undergo coronary artery bypass
      graft surgery (CABG).

      Treatment recommendations at discharge:

        -  Patients with admission HbA1c < 7%:

             -  Patients without a history of diabetes not requiring subcutaneous (SC) insulin in
                the hospital will be discharged on no antidiabetic therapy.

             -  Patients without a history of diabetes requiring SC insulin therapy in the hospital
                will be discharged on metformin monotherapy. A patient without a history of
                diabetes who requires SC insulin is likely a newly diagnosed diabetic. The HbA1c
                value will be important to confirm the diagnosis. If the HbA1c is >6.5%, he/she
                will be diagnosed with diabetes. We do not anticipate that a patient without a
                history of diabetes and with an HbA1c <6.5% will require insulin treatment or oral
                agents long-term. Those patients will be discharged on no anti diabetic therapy
                with repeated testing after discharge to rule out diabetes.

             -  Patients with a history of diabetes will be discharged on their same outpatient
                antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).

             -  Assure there are no contraindications to oral agents (i.e.Thiazolidinediones (TZDs)
                and heart failure; metformin and renal failure or heart failure).

        -  Patients with Admission HbA1c between 7% and 9%:

             -  Treatment naïve patients not on any pharmacologic treatment prior to admission will
                be discharged on metformin monotherapy or a combination of metformin and a single
                dose of basal (glargine) insulin at 50% of total daily hospital dose.

             -  Patients treated with oral antidiabetic agents or glucagon-like peptide-1 (GLP1)
                analogs prior to admission will be discharged on pre-admission oral antidiabetic
                therapy plus a single dose of glargine insulin at 50% of the total daily hospital
                dose.

             -  Patients treated with combination of oral antidiabetic agents and basal insulin
                (NPH insulin also known as Neutral Protamine Hagedorn insulin, glargine, detemir)
                prior to admission will be discharged on pre-admission oral antidiabetic therapy
                plus a single dose of glargine insulin or with basal bolus insulin regimen at 50%
                of total daily hospital dose.

             -  Patients not to be treated with oral agents will be discharged on glargine
                monotherapy or basal bolus at 100% of inpatient total daily dose.

             -  Admission HbA1c ≥ 9% prior to admission:

             -  Discharge on basal bolus regimen at same inpatient total daily insulin dose.

             -  Basal insulin (glargine) once daily, at the same time of the day.

             -  Rapid-acting insulin (glulisine) before meals.

             -  Alternative treatment: If no contraindications to oral agents (i.e.,
                Thiazolidinediones (TZDs) and heart failure; metformin and renal failure) restart
                oral agents in combination to glargine once daily at 80% of total daily hospital
                dose.
    

Intervention name(s): Metformin; Glargine insulin; Glulisine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Glucophage; Lantus; Apidra
Intervention MeSH terms: Metformin; Insulin Glargine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Bypass Graft surgery