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Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI2D)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Maria Mori Brooks, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00006305
First received: September 28, 2000
Last updated: January 12, 2016
Last verified: January 2016
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 
Overall Participants Analyzed 
[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


  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
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  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.


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 by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Maria Mori Brooks, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00006305     History of Changes
Other Study ID Numbers: 133
U01HL061744 ( US NIH Grant/Contract Award Number )
U01HL061746 ( US NIH Grant/Contract Award Number )
U01HL061748 ( US NIH Grant/Contract Award Number )
U01HL063804 ( US NIH Grant/Contract Award Number )
Study First Received: September 28, 2000
Results First Received: January 27, 2011
Last Updated: January 12, 2016
Health Authority: United States: Federal Government