Trial record 1 of 1 for:    NCT00000620
Previous Study | Return to List | Next Study

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
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Diabetes Mellitus, Type 2
Diabetes Mellitus
Coronary Disease
Drug: Hypoglycemic Agents
Drug: Intensive BP treatment
Drug: Fenofibrate + simvastatin
Drug: Standard glycemia control
Drug: Standard BP control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Action to Control Cardiovascular Risk in Diabetes (ACCORD)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • total mortality [ Time Frame: 5-1/2 years ] [ Designated as safety issue: Yes ]

Enrollment: 10251
Study Start Date: September 1999
Study Completion Date: December 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Intensive glycemia control
A strategy of intensive glycemia treatment to HbA1 less than 6%
Drug: Hypoglycemic Agents
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
Active Comparator: 2: Standard glycemia control
A strategy of multiple drugs to treat HbA1c to 7.0%-7.9%
Drug: Standard glycemia control
A strategy of glycemia drugs for HbA1c 7%-7.9%
Experimental: 3: Intensive BP control
A strategy of BP treatment for SBP less than 120 mm Hg
Drug: Intensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
Active Comparator: 4: Standard BP control
A strategy of BP treatment for SBP less than 140 mm Hg
Drug: Standard BP control
A strategy of BP drugs for SBP less than 140 mm Hg
Experimental: 5: Fibrate
Blinded fenofibrate + simvastatin 20-40 mg/d
Drug: Fenofibrate + simvastatin
Blinded fenofibrate or placebo + simvastatin 20-40 mg/d

  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000620

Locations
United States, Minnesota
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States, 55404
United States, New York
Columbia University
New York, New York, United States, 10027
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Tennessee
Veterans Affairs
Memphis, Tennessee, United States, 38104
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000620     History of Changes
Other Study ID Numbers: 123
Study First Received: October 27, 1999
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Diabetes Mellitus, Non-Insulin-Dependent

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Hypertension
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Hypoglycemic Agents
Fenofibrate
Simvastatin
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents

ClinicalTrials.gov processed this record on August 27, 2014