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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01792830
First received: August 14, 2012
Last updated: September 29, 2015
Last verified: September 2015
  Purpose
Most coronary artery bypass graft 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 is after going home from the hospital. 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 on oral antidiabetic drugs or with insulin glargine injections based on their sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the average blood 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 HbA1c between 7% and 9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100% of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12 weeks after discharge.

Condition Intervention Phase
Poor Glycemic Control
Drug: Metformin
Drug: Glargine insulin
Drug: Glulisine
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:
  • Efficacy, Measured by a Change in HbA1c Levels [ Time Frame: Hospital discharge, 1 month ] [ Designated as safety issue: No ]
    Change in the level of HbA1c in a 1 month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.


Secondary Outcome Measures:
  • Readmission Rate to the Hospital [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
    Number of subjects that were readmitted to the hospital 3 months after discharge

  • Hypoglycemic Events [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
    Number of subjects that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl

  • Incidence Rates for Post-operative Complications [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
    Number of complications including infections, wound infections, readmissions

  • Severe Hypoglycemic Events [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
    Number of subjects that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl

  • Hyperglycemic Events [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
    Number of subjects that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl


Enrollment: 175
Study Start Date: October 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control HbA1c < 7%
Subjects not requiring coronary artery bypass graft surgery (CABG), with no history of diabetes with HbA1c <7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy.
Active Comparator: Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9%
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous 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: Metformin

Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.

Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.

Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin.

Other Name: Glucophage
Drug: Glargine insulin

Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.

Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.

Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.

Other Name: Lantus
Active Comparator: Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%%
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c 7%- 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

Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.

Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.

Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin.

Other Name: Glucophage
Drug: Glargine insulin

Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.

Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.

Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.

Other Name: Lantus
Active Comparator: No diabetes/ Metformin only
Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
Drug: Metformin

Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.

Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.

Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin.

Other Name: Glucophage
Active Comparator: Diabetic/antidiabetic regimen
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen. Subjects will receive one of the three treatment options based on their blood glucose levels: Metformin alone, both metformin and glargine insulin or glargine alone.
Drug: Metformin

Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.

Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.

Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin.

Other Name: Glucophage
Drug: Glargine insulin

Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.

Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.

Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.

Other Name: Lantus
Active Comparator: No diabetes/ Insulin only
Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c <7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital.
Drug: Glargine insulin

Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.

Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.

Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.

Other Name: Lantus
Active Comparator: Diabetes/Insulin only
Subjects requiring coronary artery bypass graft surgery (CABG) with an admission HbA1c >9% and persistent hyperglycemia will be given basal insulin (glargine) once daily, at the same time of the day and rapid-acting insulin (glulisine) before meals.
Drug: Glargine insulin

Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.

Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.

Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose.

Other Name: Lantus
Drug: Glulisine
Glulisine is an injectable, recombinant insulin analog. The total daily dose varies between 0.5 to 1 unit/kg/day depending on the levels of blood glucose. Glulisine will be given within 15 minutes before a meal or within 20 minutes after starting a meal.
Other Name: Apidra

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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 coronary artery bypass graft surgery (CABG).
  2. Post surgical hyperglycemia (Blood glucose >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 a glomerular filtration rate < 30 ml/min) or clinically significant hepatic failure.
  2. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic states.
  3. Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
  4. Patients or next-to-kin with mental conditions 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
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory Midtown Hospital
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30326
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Guillermo E Umpierrez, MD Emory University
  More Information

Responsible Party: Guillermo Umpierrez, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01792830     History of Changes
Other Study ID Numbers: IRB00056365 
Study First Received: August 14, 2012
Results First Received: May 11, 2015
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Coronary Artery Bypass Graft surgery

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016