ACCORD Trial

Trial Details:

Acronym: Action to Control CardiOvascular Risk in Diabetes

Purpose: Evaluate intensive glucose controll in type II diabetic patients on cardiovascualr risk

Format: Double blind, multicenter, randomized controlled trial

Treatment Group: Intensive glucose control with hemoglobin A1c < 6.0%

Control Group: Standard glycemic control with hemoglobin A1c 7.0-7.9%

Number of Patients: 10,251

Inclusion Criteria: 

• Diabetes mellitus type II
• Hemoglobin A1C ≥ 7.5
• Age 40-79 with coronary artery disease

      OR

• Age 55-79 with any of the following:
  • Atherosclerosis (including PAD)
  • Albuminuria
  • Left ventricular hypertrophy
  • ≥ 2 cardiovascular risk factors.

Exclusion Criteria: 

• Frequent or recent serious hypoglycemic events
• Unwillingness to perform home glucose monitoring or inusulin
• BMI > 45
• Cr > 1.5 mg/dL
• Serious illness

Primary Endpoint: Composite annual rate of non-fatal MI, non-fatal stroke or cardiovascular death

Secondary Endpoints:

• Annual rate of all-cause mortality
• Annual rate of cardiovascular mortality
• Annual rate of non-fatal MI
• Annual rate of non-fatal stroke
• Annual rate of heart failure

Summary:

The ACCORD trial evaluated cardiovascular risk in type II diabetes patients with intensive glycemic control (hemoglobin A1c < 6.0%) versus standard glycemic control (hemoglobin A1c 7.0-7.9%). The primary endpoint of annual rate of all-cause mortality including cardiovascular mortality was significantly increased in the intensive glycemic control arm and thus the trial was stopped early. 

Original Publication:

Gerstein HC, et al. N Engl J Med. 2008;doi:10.1056/NEJMoa0802743.