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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborators: |
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 |
| 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 |
|---|---|---|
|
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 |
|---|---|
|
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: | Wake Forest University School of Medicine ( Robert P. Byington, MPH, PhD, FAHA ) |
| Study ID Numbers: | 123 |
| Study First Received: | October 27, 1999 |
| Last Updated: | December 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00000620 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Diabetes Mellitus, Non-Insulin-Dependent |
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Antimetabolites Atherosclerosis Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Arteriosclerosis Hypoglycemic Agents Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Arterial Occlusive Diseases Heart Diseases Metabolic Diseases Hyperlipidemias |
Simvastatin Antilipemic Agents Vascular Diseases Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Procetofen Pharmacologic Actions Coronary Disease Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Coronary Artery Disease Hypertension |
