Overview

This trial is active, not recruiting.

Condition poor glycemic control
Treatments metformin, glargine+ metformin, metformin+glargine+aspart
Phase phase 3
Sponsor Emory University
Start date October 2012
End date January 2014
Trial size 320 participants
Trial identifier NCT01792830, IRB00056365

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients without a history of diabetes with an A1C < 7% not requiring SC insulin in the hospital will be discharge on no antidiabetic therapy. Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital will be discharged on oral metformin. Patients with a history of diabetes with an A1C < 7% will be discharged on their same outpatient antidiabetic regimen.
metformin Glucophage
(Active Comparator)
Patients with an A1C between 7% and 9% requiring SC insulin therapy in the hospital will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of total daily hospital dose.
glargine+ metformin Lantus+glucophage
(Active Comparator)
Patients with an A1C > 9% will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of total daily hospital dose or with basal bolus regimen at same inpatient total daily insulin dose.
metformin+glargine+aspart Glucophage+Lantus+Novolog

Primary Outcomes

Measure
blood glucose
time frame: during 3 months following hospitalization
hemoglobin A1c
time frame: during 3 months following hospitalization

Secondary Outcomes

Measure
hypoglycemia
time frame: during 3 months after hospitalization
severe hyperglycemia
time frame: during the 3 months following discharge
severe hypoglycemia
time frame: during 3 months after hospitalization
readmissions
time frame: within 3 months after hospitalization
emergency room visits
time frame: within 3 months after hospitalization
Postoperative complications
time frame: within 3 months after hospitalization

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
Principal investigator Guillermo E Umpierrez, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Emory University.