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Glossary
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| Sponsors and Collaborators: |
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 |
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| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00000620 |
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 |
|---|---|---|
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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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Action to Control Cardiovascular Risk in Diabetes (ACCORD) |
| Enrollment: | 10251 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
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1: Intensive glycemia control: Experimental
A strategy of intensive glycemia treatment to HbA1 less than 6%
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Drug: Hypoglycemic Agents
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
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2: Standard glycemia control: Active Comparator
A strategy of multiple drugs to treat HbA1c to 7.0%-7.9%
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Drug: Standard glycemia control
A strategy of glycemia drugs for HbA1c 7%-7.9%
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3: Intensive BP control: Experimental
A strategy of BP treatment for SBP less than 120 mm Hg
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Drug: Intensive BP treatment
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
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4: Standard BP control: Active Comparator
A strategy of BP treatment for SBP less than 140 mm Hg
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Drug: Standard BP control
A strategy of BP drugs for SBP less than 140 mm Hg
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5: Fibrate: Experimental
Blinded fenofibrate + simvastatin 20-40 mg/d
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Drug: Fenofibrate + simvastatin
Blinded fenofibrate or placebo + simvastatin 20-40 mg/d
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Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and 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 | |
| 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
| Responsible Party: | National Heart, Lung, and Blood Institute ( Denise Simons-Morton, M.D., ACCORD Project Officer ) |
| Study ID Numbers: | 123 |
| Study First Received: | October 27, 1999 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000620 |
| Health Authority: | United States: Food and Drug Administration |
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Diabetes Mellitus, Non-Insulin-Dependent |
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Atherosclerosis Arterial Occlusive Diseases Hyperlipidemias Metabolic Diseases Heart Diseases Simvastatin Myocardial Ischemia Diabetes Mellitus Vascular Diseases Endocrine System Diseases Arteriosclerosis Ischemia |
Procetofen Insulin Coronary Disease Diabetes Mellitus, Type 2 Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypercholesterolemia Dyslipidemias Coronary Artery Disease Lipid Metabolism Disorders Hypertension |
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Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
