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

Condition(s) targeted: Poor Glycemic Control

Intervention: metformin (Drug); Glargine+ metformin (Drug); Metformin+glargine+aspart (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Guillermo E Umpierrez, MD, Principal Investigator, Affiliation: Emory University

Most cardiac (heart) bypass 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 after going home from the hospital. Accordingly, 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 (sent home) on diabetes pills or with insulin glargine injections based on their sugar control. Patients with admission A1c < 7% (a laboratory value that shows the average 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 A1c between 7% and 9% will be discharged on insulin glargine at 50-80% of the dose used in the hospital and their home diabetes pills. Those with an A1c > 9% will be discharged on glargine at 80-100% of the dose used in the hospital in addition their home diabetes pill or with insulin glargine and insulin glulisine. The primary outcome will be a change in A1c at 4 and 12 weeks after discharge. Approximately 300 patients will be enrolled in CABG discharge trial.

Official title: Prospective Study Aim to Determine the Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Cardiac Surgery Patients With Perioperative Hyperglycemia

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

blood glucose

hemoglobin A1c

Secondary outcome:

hypoglycemia

severe hyperglycemia

severe hypoglycemia

readmissions

emergency room visits

Postoperative complications

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males or females between the ages of 18 and 80 years undergoing primary CABG. 2. Post surgical hyperglycemia (BG > 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 GFR < 30 ml/min) or clinically significant hepatic failure. 2. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (89). 3. Moribund patients and those at imminent risk of death (brain death or cardiac standstill). 4. Patients or next-to-kin with mental condition 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.

Emory Midtown Hospital, Atlanta, Georgia 30308, United States

Emory University Hospital, Atlanta, Georgia 30326, United States

Grady Memorial Hospital, Atlanta, Georgia 30303, United States

Starting date: October 2012
Last updated: July 2, 2014