Action to Control Cardiovascular Risk in Diabetes (ACCORD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000620
First received: October 27, 1999
Last updated: February 7, 2014
Last verified: February 2009

October 27, 1999
February 7, 2014
September 1999
June 2009   (final data collection date for primary outcome measure)
First occurence of a major CVD event, specifically nonfatal heart attack, nonfatal stroke, or cardiovascular death (measured throughout the study) [ Time Frame: 5-1/2 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00000620 on ClinicalTrials.gov Archive Site
total mortality [ Time Frame: 5-1/2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Action to Control Cardiovascular Risk in Diabetes (ACCORD)

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.

BACKGROUND:

Currently, about 17 million Americans have been diagnosed with 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, of whom 27 million will have the type 2 form. Cardiovascular disease (CVD) is the leading cause of death in people with type 2 diabetes; these individuals die of CVD at rates two to four 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 are also at a greater risk for developing 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.

DESIGN NARRATIVE:

The three strategies tested in ACCORD will include the following: (1) Blood sugar - ACCORD will determine whether lowering blood glucose to a level 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. 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 (systolic pressure less than 120 mm Hg) will better reduce CVD risk, as compared to a usually-targeted level in current clinical practice (i.e., below the definition of hypertension; systolic pressure less than 140 mm Hg). (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 LDL cholesterol.

All ACCORD participants will receive their blood sugar treatment from the study. Based on whatever else 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. Individuals who are selected and consent to participate in the ACCORD study will continue to see their personal physician for all other health care.

The ACCORD clinical trial enrolled 10,251 adults with type 2 diabetes in 77 clinics around the United States and Canada. All eligible participants will be in the blood sugar control part of the trial. Participants were randomly assigned to a treatment regimen involving either aggressive control or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they were assigned to either the high blood pressure or high blood fats (cholesterol and triglycerides) part of the study.

On February 6, 2008, the NHLBI announced that participants in the intensive glycemia treatment will be transitioned to the ACCORD standard treatment approach due to higher mortality in the intensive treatment group. The blood pressure and lipid trials are continuing as designed.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Atherosclerosis
  • Cardiovascular Diseases
  • Hypercholesterolemia
  • Hypertension
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus
  • Coronary Disease
  • Drug: Hypoglycemic Agents
    Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
  • Drug: Intensive BP treatment
    A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
  • Drug: Fenofibrate + simvastatin
    Blinded fenofibrate or placebo + simvastatin 20-40 mg/d
  • Drug: Standard glycemia control
    A strategy of glycemia drugs for HbA1c 7%-7.9%
  • Drug: Standard BP control
    A strategy of BP drugs for SBP less than 140 mm Hg
  • Experimental: 1: Intensive glycemia control
    A strategy of intensive glycemia treatment to HbA1 less than 6%
    Intervention: Drug: Hypoglycemic Agents
  • Active Comparator: 2: Standard glycemia control
    A strategy of multiple drugs to treat HbA1c to 7.0%-7.9%
    Intervention: Drug: Standard glycemia control
  • Experimental: 3: Intensive BP control
    A strategy of BP treatment for SBP less than 120 mm Hg
    Intervention: Drug: Intensive BP treatment
  • Active Comparator: 4: Standard BP control
    A strategy of BP treatment for SBP less than 140 mm Hg
    Intervention: Drug: Standard BP control
  • Experimental: 5: Fibrate
    Blinded fenofibrate + simvastatin 20-40 mg/d
    Intervention: Drug: Fenofibrate + simvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10251
December 2012
June 2009   (final data collection date for primary outcome measure)

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)
Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00000620
123
Yes
National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institute on Aging (NIA)
  • National Eye Institute (NEI)
  • Centers for Disease Control and Prevention
Study Director: Denise Simons-Morton, MD, PhD National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: William Friedewald, MD Columbia University, New York, NY
Principal Investigator: Robert Byington, PhD Wake Forest University, Winston-Salem, NC
National Heart, Lung, and Blood Institute (NHLBI)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP