Action to Control Cardiovascular Risk in Diabetes (ACCORD)

Summary

The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.

Conditions

• Atherosclerosis
• Cardiovascular Diseases
• Hypercholesterolemia
• Hypertension
• Diabetes Mellitus, Type 2
• Diabetes Mellitus
• Coronary Disease

Interventions

DRUG

Anti-hyperglycemic Agents

Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control \<6%; standard control 7.0-7.9%).

DRUG

Anti-hypertensive Agents

Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control \<120 mm Hg; standard control \<140 mm Hg).

DRUG

Blinded fenofibrate or placebo plus simvastatin

Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR \<50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• National Eye Institute (NEI)

  collaborator NIH

• Centers for Disease Control and Prevention

  collaborator FED

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• Denise Simons-Morton, MD, PhD · National Heart, Lung, and Blood Institute (NHLBI)

• William Friedewald, MD · Columbia University, New York, NY

• Robert Byington, PhD · Wake Forest University, Winston-Salem, NC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-09-30

Primary Completion

2009-06-30

Completion

2012-12-31

Countries

• United States
• Canada

Study Locations