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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
Results First Received: May 11, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Poor Glycemic Control
Interventions: Drug: Metformin
Drug: Glargine insulin
Drug: Glulisine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from Emory University Hospital, Emory University Hospital-Midtown and Grady Hospital from January 2013 to February 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, were discharged from the hospital without any antidiabetic therapy.
No Diabetes/ Metformin Only Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
No Diabetes Insulin Group Patients with an HbA1c < 7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
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.
Diabetic/ Metformin and 50-Glargine Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
Diabetic/ Metformin and 80-Glargine Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
Diabetic/Glargine and Glulisine Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.

Participant Flow:   Overall Study
    Control     No Diabetes/ Metformin Only     No Diabetes Insulin Group     Diabetic/ Antidiabetic Regimen     Diabetic/ Metformin and 50-Glargine     Diabetic/ Metformin and 80-Glargine     Diabetic/Glargine and Glulisine  
STARTED     84     3     4     27     41     4     12  
COMPLETED     59     3     4     22     29     4     9  
NOT COMPLETED     25     0     0     5     12     0     3  
Withdrawal by Subject                 22                 0                 0                 4                 9                 0                 2  
Death                 3                 0                 0                 1                 2                 0                 1  
Adverse Event                 0                 0                 0                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
No Diabetes/ Metformin Only Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
No Diabetes/ Insulin Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin.
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.
Diabetic/ Metformin and 50-Glargine Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
Diabetic/ Metformin and 80-Glargine Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
Diabetic/ Glargine and Glulisine Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
Total Total of all reporting groups

Baseline Measures
    Control     No Diabetes/ Metformin Only     No Diabetes/ Insulin     Diabetic/ Antidiabetic Regimen     Diabetic/ Metformin and 50-Glargine     Diabetic/ Metformin and 80-Glargine     Diabetic/ Glargine and Glulisine     Total  
Number of Participants  
[units: participants]
  84     3     4     27     41     4     12     175  
Age  
[units: participants]
               
<=18 years     0     0     0     0     0     0     0     0  
Between 18 and 65 years     41     0     1     12     15     4     11     84  
>=65 years     43     3     3     15     26     0     1     91  
Gender  
[units: participants]
               
Female     23     0     1     8     11     3     3     49  
Male     61     3     3     19     30     1     9     126  
Region of Enrollment  
[units: participants]
               
United States     84     3     4     27     41     4     12     175  



  Outcome Measures
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1.  Primary:   Efficacy, Measured by a Change in HbA1c Levels   [ Time Frame: Hospital discharge, 1 month ]

2.  Secondary:   Readmission Rate to the Hospital   [ Time Frame: 3 months after discharge ]

3.  Secondary:   Hypoglycemic Events   [ Time Frame: 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Incidence Rates for Post-operative Complications   [ Time Frame: 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Severe Hypoglycemic Events   [ Time Frame: 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Hyperglycemic Events   [ Time Frame: 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study had participants from other states who lived more than 50 miles away from the hospitals and did not return for their post-operative care or 12 week follow up. Some subjects preferred to complete follow ups via phone and no blood was drawn.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
phone: 404-778-1665
e-mail: geumpie@emory.edu



Responsible Party: Guillermo Umpierrez, 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