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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01792830
First received: August 14, 2012
Last updated: July 2, 2014
Last verified: June 2014
  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 Intervention Phase
Poor Glycemic Control
Drug: metformin
Drug: Glargine+ metformin
Drug: Metformin+glargine+aspart
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Emory University:

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


Secondary Outcome Measures:
  • hypoglycemia [ Time Frame: during 3 months after hospitalization ] [ Designated as safety issue: Yes ]
    frequency of hypoglycemia (BG</= 60)

  • 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</= 40)

  • 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


Estimated Enrollment: 320
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: metformin
Other Name: Glucophage
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.
Drug: Glargine+ metformin
Other Name: Lantus+glucophage
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.
Drug: Metformin+glargine+aspart
Other Name: Glucophage+Lantus+Novolog

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792830

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30326
Emory Midtown Hospital
Atlanta, Georgia, United States, 30308
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo E Umpierrez, MD Emory University
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, MD., Emory University
ClinicalTrials.gov Identifier: NCT01792830     History of Changes
Other Study ID Numbers: IRB00056365
Study First Received: August 14, 2012
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glargine
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014