At a glance
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Prospective Study Aim to Determine the Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Cardiac Surgery Patients With Perioperative Hyperglycemia
In Brief
A Phase 3 clinical trial evaluating Metformin, Glargine insulin, and 1 other intervention for Poor Glycemic Control. Completed, enrolled 175 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.