Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients
being assigned at random to initial elective revascularization with aggressive medical
therapy or aggressive medical therapy alone with equal probability, and simultaneously being
assigned at random to an insulin providing or insulin sensitizing strategy of glycemic
control (with a target value for HbA1c of less than 7.0% for all patients).
SPECIFIC AIMS
A. Primary Aim
The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment
efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the
setting of uniform glycemic control and intensive management of all other risk factors
including dyslipidemia, hypertension, smoking, and obesity:
1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization
of choice (surgical or catheter-based) combined with aggressive medical therapy results
in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a
strategy of hyperglycemia management directed at insulin sensitization results in lower
5-year mortality compared to a strategy of insulin provision.
B. Secondary Aims
The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial
infarction or stroke combined endpoint event rate between the revascularization versus
medical therapy groups and between the insulin sensitization versus insulin provision groups;
b) comparing rates of myocardial infarction, other ischemic events, angina and quality of
life associated with each revascularization and hyperglycemia management strategy; c)
evaluating the relative economic costs associated with the trial treatment strategies, d)
exploring the effect of glycemic control strategy on the progression and mechanism of
vasculopathy including changes in PAI-1 gene expression.
Phase:
Phase 3
Details
Lead Sponsor:
University of Pittsburgh
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)