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 intensive lipid management.

Condition	Treatment or Intervention	Phase
Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus, non-insulin dependent Diabetes Mellitus Coronary Disease	Drug: hypoglycemic agents  Drug: hydroxymethylglutaryl-CoA Reductase inhibitors  Drug: antihypertensive agents	Phase III

BACKGROUND: Currently, about 17 million Americans have diagnosed diabetes and more than 90 percent of them have type 2 diabetes. The number of people with this form of diabetes, formerly known as adult onset or non-insulin dependent diabetes, is growing rapidly. By 2050, the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million, 27 million of whom will have the type 2 form. Cardiovascular disease (CVD) is the leading cause of death in people with type 2 diabetes, who die of CVD at rates 2 to 4 times higher than those who do not have diabetes. They also experience more nonfatal heart attacks and strokes.

Type 2 diabetes is associated with older age and is more common in those who are overweight or obese and have a family history of diabetes. Women with a history of diabetes during pregnancy, adults with impaired glucose tolerance, people with a sedentary lifestyle, and members of a minority race/ethnicity also are at greater risk for type 2 diabetes. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes.

The ACCORD clinical trial seeks to enroll 10,000 adults with type 2 diabetes in 70 clinics around the United States and Canada. All eligible participants will be in the blood sugar control part of the trial. Patients will be randomly assigned to a treatment regimen involving either aggressive or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they will be assigned to either the high blood pressure or high blood fats (cholesterol and triglycerides) part of the study.

DESIGN NARRATIVE: The three strategies tested in ACCORD will be: (1) Blood sugar. ACCORD will determine whether lowering blood glucose to a goal closer to normal than called for in current guidelines reduces CVD risk. The study will determine effects on CVD of that level compared with a level that is usually targeted. (2) Blood pressure. Many people with type 2 diabetes have high blood pressure (HBP). The blood pressure part of the trial will determine the effects of lowering blood pressure in the context of good blood sugar control. ACCORD will determine whether lowering blood pressure to normal (<120mmHg systolic) will reduce CVD risk better compared to a usually-targeted level in current clinical practice, i.e., below the definition of hypertension (<140mmHg systolic). (3) Blood Fats. Many people with diabetes have high levels of LDL ("bad") cholesterol and triglycerides, as well as low levels of HDL ("good") cholesterol. ACCORD participants who are selected for this part of the trial will be assigned to an intervention that improves blood fat levels. This part of the study will look at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol, all in the context of good blood sugar control. A drug from a class of drugs called "fibrates" will be used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called "statins" will be used to lower the LDL cholesterol.

All ACCORD participants will receive their blood sugar treatment from the study. Based on the additional part of the trial they are assigned to, participants will also receive their cholesterol or high blood pressure care from the study. Study participants will receive all medication and treatments related to the study free of charge. Patients who are selected and consent to participate in the ACCORD study will continue to see their personal physician for all their other health care.

Ages Eligible for Study:  40 Years   -   79 Years,  Genders Eligible for Study:  Both

Criteria

Ages Eligible for Study: 1/ >= 40 years for anyone with a history of clinical cardiovascular disease (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization or demonstrated angina); 2 >= 55 years for anyone without a history of clinical cardiovascular disease but considered at high risk of CVD event.

The definition of Type 2 diabetes mellitus follows the new American Diabetes Association guidelines of a fasting plasma glucose level > 126 mg/dl (7.0 mmol/l) or a 2-hour postload value in the oral glucose tolerance test of > 200 mg/dl, with confirmation by retesting.

Minnesota
      Minneapolis Medical Research Foundation, Minneapolis,  Minnesota,  United States; Recruiting
New York
      Columbia University, New York,  New York,  United States; Recruiting
North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  United States; Recruiting
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  United States; Recruiting
Tennessee
      Veterans Affairs, Memphis,  Tennessee,  United States; Recruiting
Washington
      University of Washington, Seattle,  Washington,  United States; Recruiting
Canada, Ontario
      McMaster University, Hamilton,  Ontario,  Canada; Recruiting

Study ID Numbers:  123
Record last reviewed:  September 2004
Record first received:  October 27, 1999
ClinicalTrials.gov Identifier:  NCT00000620
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29