Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Maria Mori Brooks, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00006305
First received: September 28, 2000
Last updated: January 24, 2012
Last verified: January 2012
Results First Received: January 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Coronary Disease
Cardiovascular Diseases
Heart Diseases
Insulin Resistance
Diabetes Mellitus
Diabetes Mellitus, Non-Insulin-Dependent
Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions
Procedure: Coronary Artery Bypass
Drug: Biguanides, thiazolidinediones
Drug: Insulin, sulfonylurea
Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers

  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
A total of 2,368 patients were enrolled at 49 clinical centers from United States, Canada, Brazil, Mexico, Czech Republic, and Austria between January 1, 2001 and March 31, 2005. Each of the 2368 patients was simultaneously assigned to initial revascularization or medical therapy and assigned to insulin providing or insulin sensitizing therapy.

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
Revascularization and Insulin Providing (IP) Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
Revascularization and Insulin Sensitizing (IS) Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
Medical Therapy and Insulin Providing (IP) Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
Medical Therapy and Insulin Sensitizing (IS) Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy

Participant Flow:   Overall Study
    Revascularization and Insulin Providing (IP)     Revascularization and Insulin Sensitizing (IS)     Medical Therapy and Insulin Providing (IP)     Medical Therapy and Insulin Sensitizing (IS)  
STARTED     592     584     593     599  
COMPLETED     575     574     578     585  
NOT COMPLETED     17     10     15     14  
Withdrawal by Subject                 17                 10                 15                 14  



  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
Revascularization and Insulin Providing (IP) Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
Revascularization and Insulin Sensitizing (IS) Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
Medical Therapy and Insulin Providing (IP) Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
Medical Therapy and Insulin Sensitizing (IS) Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
Total Total of all reporting groups

Baseline Measures
    Revascularization and Insulin Providing (IP)     Revascularization and Insulin Sensitizing (IS)     Medical Therapy and Insulin Providing (IP)     Medical Therapy and Insulin Sensitizing (IS)     Total  
Number of Participants  
[units: participants]
  592     584     593     599     2368  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     362     354     350     373     1439  
>=65 years     230     230     243     226     929  
Age  
[units: years]
Mean ± Standard Deviation
  62.3  ± 8.5     62.4  ± 9.1     62.7  ± 8.8     62.2  ± 9.3     62.4  ± 8.9  
Gender  
[units: participants]
         
Female     176     172     172     182     702  
Male     416     412     421     417     1666  
Region of Enrollment  
[units: participants]
         
United States     376     367     376     380     1499  
Canada     87     88     89     89     353  
Brazil     89     89     89     89     356  
Mexico     21     21     22     21     85  
Europe     19     19     17     20     75  



  Outcome Measures
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1.  Primary:   Number of Participants With All-Cause Mortality   [ Time Frame: five years ]

2.  Secondary:   Number of Participants With Death, Myocardial Infarction, or Stroke   [ Time Frame: five years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Maria Brooks
Organization: University of Pittsburgh
phone: 4126241618
e-mail: brooks@edc.pitt.edu


Publications:
Detre KM, Frye RL, Genuth S, guest editors. A Symposium: Treatment of Coronary Artery Disease and Type 2 Diabetes: The Rationale for the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. American Journal of Cardiology 2006; 97(suppl 12A): 1G-65G.

Publications automatically indexed to this study:


Responsible Party: Maria Mori Brooks, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00006305     History of Changes
Other Study ID Numbers: 133, U01HL061744, U01HL061746, U01HL061748, U01HL063804
Study First Received: September 28, 2000
Results First Received: January 27, 2011
Last Updated: January 24, 2012
Health Authority: United States: Federal Government