CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10,251 enrolled
Drug / intervention
Anti-hyperglycemic Agents +2 moredrug
Likely dose
Fenofibrate 160 mg/day (or 54 mg/day if eGFR <50 mL/min/1.73m²) plus simvastatin 20-40 mg/day, or matching placebosAI-extracted
Key inclusion· 4
  • Type 2 diabetes mellitus diagnosed by fasting plasma glucose >126 mg/dL or 2-hour postload glucose >200 mg/dL on oral glucose tolerance test (confirmed by retest)
  • Age ≥40 years with history of cardiovascular disease (prior MI, stroke, coronary/peripheral/carotid revascularization, or angina)
  • Age ≥55 years with high cardiovascular risk, including existing CVD, subclinical disease, or ≥2 CVD risk factors (prior CVD history not required)
  • HbA1c 7.5-9% (if on multiple diabetes drugs) or 7.5-11% (if on fewer drugs)
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000620
NCT00000620Phase 3Completed

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Oct 28, 1999·Updated Nov 22, 2016

In Brief

A Phase 3 clinical trial evaluating Anti-hyperglycemic Agents, Anti-hypertensive Agents, and 1 other intervention for Atherosclerosis and 6 related conditions. Completed, enrolled 10,251 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 28, 1999
Enrollment StartSep 1, 1999
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 26.7 years ago

Interventions

Anti-hyperglycemic Agentsdrug

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%).

Anti-hypertensive Agentsdrug

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

Blinded fenofibrate or placebo plus simvastatindrug

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.