Rationale, design, and methods for glycemic control in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial

A major therapeutic question in considering accelerated atherogenesis in patients with type 2 diabetes mellitus is whether reducing insulin resistance, as a proximal defect of a host of proatherogenic abnormalities including hyperglycemia, will be superior for decreasing mortality and coronary artery disease (CAD) risk compared with treating hyperglycemia to overcome insulin resistance with insulin-providing agents. This question is highly relevant, since earlier targeted glycemic control trials utilizing conventional glucose-lowering strategies that increase insulin levels have generally failed to reduce CAD risk despite markedly reducing microvascular risk. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial seeks to determine whether primarily using an insulin-sensitizing strategy for treatment of type 2 diabetes is superior when compared with primarily using an insulinproviding strategy with regard to cardiovascular outcomes. This article presents the rationale, design, and methods being used to test the glycemic control hypothesis in BARI 2D. (c) 2006 Elsevier Inc. All rights reserved.