Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Condition: Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus; Coronary Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Intervention: Anti-hyperglycemic Agents; Anti-hypertensive Agents; Blinded fenofibrate or placebo plus simvastatin
Intervention description: 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%).; Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg).; 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.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Pioglitazone; Insulin Aspart; Glimepiride; Rosiglitazone; Insulin Detemir; Acarbose; Repaglinide; Hypoglycemic Agents; Metoprolol; Felodipine; Amlodipine; Valsartan; Hydrochlorothiazide; Carvedilol; Candesartan; Candesartan cilexetil; Lisinopril; Chlorthalidone; Diltiazem; Benazepril; Hydralazine; Antihypertensive Agents; Reserpine; Hydrochlorothiazide, lisinopril drug combination; Hydrochlorothiazide-triamterene; Triamterene; Furosemide; Simvastatin; Fenofibrate; Terazosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 10251.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Non-Insulin-Dependent

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes
             Association guidelines, which include a fasting plasma glucose level greater than 126
             mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of
             greater than 200 mg/dl, with confirmation by a retest

          -  For participants aged 40 years or older, history of CVD (heart attack, stroke, history
             of coronary revascularization, history of peripheral or carotid revascularization, or
             demonstrated angina)

          -  For participants aged 55 years or older, a history of CVD is not required, but
             participant must be considered to be at high risk for experiencing a CVD event due to
             existing CVD, subclinical disease, or 2+ CVD risk factors

          -  HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)