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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Poor Glycemic Control
Intervention	Drug: metformin Drug: Glargine+ metformin Drug: Metformin+glargine+aspart
Phase	Phase 3
Sponsor	Emory University
Responsible Party	Emory University
ClinicalTrials.gov Identifier	NCT01792830
First Received	August 14, 2012
Last Updated	November 12, 2013
Last verified	July 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 14, 2012
Last Updated Date	November 12, 2013
Start Date	October 2012
Estimated Primary Completion Date	October 2014
Current Primary Outcome Measures	blood glucose [Time Frame: during 3 months following hospitalization] [Designated as safety issue: No]Change in daily mean fasting blood glucose and premeal blood glucose in a 3 month period after discharge from the hospital hemoglobin A1c [Time Frame: during 3 months following hospitalization] [Designated as safety issue: No]Change in daily mean blood glucose in a 3 month period after discharge from the hospital
Current Secondary Outcome Measures	hypoglycemia [Time Frame: during 3 months after hospitalization] [Designated as safety issue: Yes]frequency of hypoglycemia (BG severe hyperglycemia [Time Frame: during the 3 months following discharge] [Designated as safety issue: Yes]frequency of severe hyperglycemia (BG>/=300 mg/dl) severe hypoglycemia [Time Frame: during 3 months after hospitalization] [Designated as safety issue: Yes]frequency of hypoglycemia (BG readmissions [Time Frame: within 3 months after hospitalization] [Designated as safety issue: No]number of hospital readmissions after discharge from the hospital emergency room visits [Time Frame: within 3 months after hospitalization] [Designated as safety issue: No]number of emergency room visits after discharge from the hospital Postoperative complications [Time Frame: within 3 months after hospitalization] [Designated as safety issue: No]number of postoperative complications after discharge from the hospital

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft(CABG) Patients
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
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Poor Glycemic Control
Intervention	Drug: metformin Other Names: GlucophageDrug: Glargine+ metformin Other Names: Lantus+glucophageDrug: Metformin+glargine+aspart Other Names: Glucophage+Lantus+Novolog
Study Arm (s)	Active Comparator: A1C < 7% 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. Active Comparator: A1C 7%- 9% 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. Active Comparator: A1C > 9% 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	320
Estimated Completion Date	October 2014
Estimated Primary Completion Date	June 2014
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Dawn D Smiley 404-778-1664 dsmiley@emory.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01792830
Other Study ID Numbers	IRB00056365
Has Data Monitoring Committee	Yes
Information Provided By	Emory University
Study Sponsor	Emory University
Collaborators	Not Provided
Investigators	Principal Investigator: Guillermo E Umpierrez, MD Emory University
Verification Date	July 2013

Locations[ + expand ][ + ]

Emory University Hospital	Atlanta, Georgia, United States, 30326 Contact: Dawn SMiley, MD \| 404-778-1687 Recruiting
Emory Midtown Hospital	Atlanta, Georgia, United States, 30308 Contact: Dawn Smiley, MD \| 404-778-1687 Recruiting
Grady Memorial Hospital	Atlanta, Georgia, United States, 30303 Suspended