drugset / Trial / NCT01792830

Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft (CABG) Patients

NCT01792830

Phase 3 Completed 175 enrolled Emory University
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-10
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin glulisine Protein / enzyme biologic 0.5 iu/kg Other
Comparator Insulin glulisine Protein / enzyme biologic 1 iu/kg Other
Comparator Metformin Small molecule Oral
Comparator insulin glargine Protein / enzyme biologic 50 % Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 80 % Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 100 % Subcutaneous