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

August 14, 2012
July 2, 2014
October 2012
January 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01792830 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Coronary Artery Bypass Graft(CABG) Patients
Prospective Study Aim to Determine the Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Cardiac Surgery Patients With Perioperative Hyperglycemia

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Poor Glycemic Control
  • Drug: metformin
    Other Name: Glucophage
  • Drug: Glargine+ metformin
    Other Name: Lantus+glucophage
  • Drug: Metformin+glargine+aspart
    Other Name: Glucophage+Lantus+Novolog
  • 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.

    Intervention: Drug: metformin
  • 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.
    Intervention: Drug: Glargine+ metformin
  • 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.
    Intervention: Drug: Metformin+glargine+aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
October 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01792830
IRB00056365
Yes
Guillermo Umpierrez, Emory University
Emory University
Not Provided
Principal Investigator: Guillermo E Umpierrez, MD Emory University
Emory University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP