Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Oct 27, 1999
Nctid: NCT00000620
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{"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16034", "InterventionBrowseLeafName"=>"Sympatholytics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20436", "InterventionBrowseLeafName"=>"Adrenergic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28887", "InterventionBrowseLeafName"=>"Adrenergic beta-1 Receptor Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3361", "InterventionBrowseLeafName"=>"Adrenergic beta-Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20445", "InterventionBrowseLeafName"=>"Adrenergic Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20194", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3982", "InterventionBrowseLeafName"=>"Antioxidants", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21559", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28884", "InterventionBrowseLeafName"=>"Adrenergic alpha-1 Receptor Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3359", "InterventionBrowseLeafName"=>"Adrenergic alpha-Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3824", "InterventionBrowseLeafName"=>"Angiotensin-Converting Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19299", "InterventionBrowseLeafName"=>"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14033", "InterventionBrowseLeafName"=>"Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5262", "InterventionBrowseLeafName"=>"Cardiotonic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5247", "InterventionBrowseLeafName"=>"Cardiac Glycosides", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30137", "InterventionBrowseLeafName"=>"Glycoside Hydrolase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16594", "InterventionBrowseLeafName"=>"Antipsychotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14164", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M22867", "InterventionBrowseLeafName"=>"Sodium Channel Blockers", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M29715", "InterventionBrowseLeafName"=>"Diuretics, Potassium Sparing", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T433", "InterventionBrowseLeafName"=>"Tannic Acid", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Hypoglycemic Agents", "InterventionBrowseBranchAbbrev"=>"Hypo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Inflammatory Agents", "InterventionBrowseBranchAbbrev"=>"Infl"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}, {"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Lipid Regulating Agents", "InterventionBrowseBranchAbbrev"=>"Lipd"}, {"InterventionBrowseBranchName"=>"Antihypertensive Agents", "InterventionBrowseBranchAbbrev"=>"AnAg"}, {"InterventionBrowseBranchName"=>"Channel Blockers", "InterventionBrowseBranchAbbrev"=>"ChanBlk"}, {"InterventionBrowseBranchName"=>"Vasodilator Agents", "InterventionBrowseBranchAbbrev"=>"VaDiAg"}, {"InterventionBrowseBranchName"=>"Natriuretic Agents", "InterventionBrowseBranchAbbrev"=>"NaAg"}, {"InterventionBrowseBranchName"=>"Anti-Arrhythmia Agents", "InterventionBrowseBranchAbbrev"=>"AnArAg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Urological Agents", "InterventionBrowseBranchAbbrev"=>"Urol"}, {"InterventionBrowseBranchName"=>"Cardiotonic Agents", "InterventionBrowseBranchAbbrev"=>"CaAg"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"Micronutrients", "InterventionBrowseBranchAbbrev"=>"Micro"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}, {"InterventionBrowseBranchName"=>"Vasoconstrictor Agents", "InterventionBrowseBranchAbbrev"=>"VaCoAg"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Other Dietary Supplements", "InterventionBrowseBranchAbbrev"=>"Ot"}]}}}, "ResultsSection"=>{"MoreInfoModule"=>{"PointOfContact"=>{"PointOfContactEMail"=>"tcraven@wakehealth.edu", "PointOfContactPhone"=>"336-716-6109", "PointOfContactTitle"=>"Tim Craven / Senior Biostatistician", "PointOfContactOrganization"=>"Wake Forest School of Medicine"}, "CertainAgreement"=>{"AgreementPISponsorEmployee"=>"No", "AgreementRestrictiveAgreement"=>"No"}}, "AdverseEventsModule"=>{"EventGroupList"=>{"EventGroup"=>[{"EventGroupId"=>"EG000", "EventGroupTitle"=>"Glycemia Trial: Intensive Control", "EventGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.", "EventGroupOtherNumAtRisk"=>"0", "EventGroupOtherNumAffected"=>"0", "EventGroupSeriousNumAtRisk"=>"5128", "EventGroupSeriousNumAffected"=>"137"}, {"EventGroupId"=>"EG001", "EventGroupTitle"=>"Glycemia Trial: Standard Control", "EventGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.", "EventGroupOtherNumAtRisk"=>"0", "EventGroupOtherNumAffected"=>"0", "EventGroupSeriousNumAtRisk"=>"5123", "EventGroupSeriousNumAffected"=>"107"}]}, "EventsTimeFrame"=>"Includes Serious Adverse Events (SAEs) reported after randomization and throughout the planned observation period, mean follow-up was 4.9 years. Data on other (non-serious) adverse events were not collected.", "SeriousEventList"=>{"SeriousEvent"=>[{"SeriousEventTerm"=>"Congestive heart failure", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"34"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"12"}]}, "SeriousEventOrganSystem"=>"Cardiac disorders", "SeriousEventAssessmentType"=>"Systematic Assessment"}, {"SeriousEventTerm"=>"Bradycardia, tachycardia, atrial fibrillation", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"13"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"4"}]}, "SeriousEventOrganSystem"=>"Cardiac disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Angina/chest pain", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"4"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"5"}]}, "SeriousEventOrganSystem"=>"Cardiac disorders", "SeriousEventAssessmentType"=>"Systematic Assessment"}, {"SeriousEventTerm"=>"Myocardial infarction", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"4"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"5"}]}, "SeriousEventOrganSystem"=>"Cardiac disorders", "SeriousEventAssessmentType"=>"Systematic Assessment"}, {"SeriousEventTerm"=>"Dizziness, hypotension, syncope", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"19"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"17"}]}, "SeriousEventOrganSystem"=>"Vascular disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Edema", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"3"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Vascular disorders", "SeriousEventAssessmentType"=>"Systematic Assessment"}, {"SeriousEventTerm"=>"Cerebrovacular accident", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Vascular disorders", "SeriousEventAssessmentType"=>"Systematic Assessment"}, {"SeriousEventTerm"=>"Cholecystitis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"5"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"11"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Hepatitis/liver failure", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"2"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"3"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Elevated creatinine, hyponatremia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"2"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Gastrointestinal bleeding", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Gastrointestinal disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Pancreatitis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"5"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"8"}]}, "SeriousEventOrganSystem"=>"Endocrine disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Ketoacidosis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Endocrine disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Hypoglycemia (fatal)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"0"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Endocrine disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Acute or chronic renal failure", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"8"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"6"}]}, "SeriousEventOrganSystem"=>"Renal and urinary disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Angioedema", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"9"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"4"}]}, "SeriousEventOrganSystem"=>"Immune system disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Thrombocytopenia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"2"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Immune system disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Blood dyscrasia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Immune system disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Felodipine toxicity", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Immune system disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Myositis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"2"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"3"}]}, "SeriousEventOrganSystem"=>"Musculoskeletal and connective tissue disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Rhabdomyolisis", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"2"}]}, "SeriousEventOrganSystem"=>"Musculoskeletal and connective tissue disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Fractures", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"2"}]}, "SeriousEventOrganSystem"=>"Musculoskeletal and connective tissue disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Weakness", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"0"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Musculoskeletal and connective tissue disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Macular edema", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Eye disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Blurred vision", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"Eye disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Shortness of breath", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Respiratory, thoracic and mediastinal disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Motor vehicle accident (fatal)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"3"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"2"}]}, "SeriousEventOrganSystem"=>"Injury, poisoning and procedural complications", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Hyperkalemia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"6"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"5"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Hyponatremia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"0"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"4"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Severe fluid retention", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"3"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Dehydration", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"2"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Vertigo", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"0"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Anemia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"0"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Hypomagnesemia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"0"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"1"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Hyperosmolar nonketotic coma", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}, {"SeriousEventTerm"=>"Toxic metabolic enecphalopathy", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"5128", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"5123", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"General disorders", "SeriousEventAssessmentType"=>"Non-systematic Assessment"}]}, "EventsDescription"=>"SAEs were defined as any adverse experience that was significantly life threatening and/or resulted in death, permanent disability, hospitalization or prolongation of hospitalization, myositis/myopathy, or hepatitis and were considered by the investigators to be possibly, probably, or definitely related to study treatments.", "EventsFrequencyThreshold"=>"0"}, "OutcomeMeasuresModule"=>{"OutcomeMeasureList"=>{"OutcomeMeasure"=>[{"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"503", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"543", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"5128", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"5123", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Glycemia Trial: Intensive Control", "OutcomeGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Glycemia Trial: Standard Control", "OutcomeGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.12", "OutcomeAnalysisParamType"=>"Hazard Ratio (HR)", "OutcomeAnalysisCINumSides"=>"2-Sided", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisParamValue"=>"0.91", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisCILowerLimit"=>"0.81", "OutcomeAnalysisCIUpperLimit"=>"1.03", "OutcomeAnalysisPValueComment"=>"P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.", "OutcomeAnalysisGroupDescription"=>"Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.", "OutcomeAnalysisStatisticalMethod"=>"Regression, Cox", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"4.9 years", "OutcomeMeasureDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).\n\nIn the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion.", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE."}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"391", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"327", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"5128", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"5123", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Glycemia Trial: Intensive Control", "OutcomeGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Glycemia Trial: Standard Control", "OutcomeGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals."}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.02", "OutcomeAnalysisParamType"=>"Hazard Ratio (HR)", "OutcomeAnalysisCINumSides"=>"2-Sided", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisParamValue"=>"1.19", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisCILowerLimit"=>"1.03", "OutcomeAnalysisCIUpperLimit"=>"1.38", "OutcomeAnalysisPValueComment"=>"P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.", "OutcomeAnalysisGroupDescription"=>"Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.", "OutcomeAnalysisStatisticalMethod"=>"Regression, Cox", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Death From Any Cause in the Glycemia Trial.", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"4.9 years", "OutcomeMeasureDescription"=>"Time to death from any cause. Secondary measure for Glycemia Trial.\n\nA finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid).", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death."}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"208", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"237", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"2363", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"2371", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"BP Trial: Intensive Control", "OutcomeGroupDescription"=>"Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"BP Trial: Standard Control", "OutcomeGroupDescription"=>"Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.20", "OutcomeAnalysisParamType"=>"Hazard Ratio (HR)", "OutcomeAnalysisCINumSides"=>"2-Sided", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisParamValue"=>"0.88", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisCILowerLimit"=>"0.73", "OutcomeAnalysisCIUpperLimit"=>"1.06", "OutcomeAnalysisPValueComment"=>"P-value is adjusted for interim monitoring. A priori significance level was 0.05.", "OutcomeAnalysisGroupDescription"=>"Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.", "OutcomeAnalysisStatisticalMethod"=>"Regression, Cox", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"4.7 years", "OutcomeMeasureDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE."}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"36", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"62", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"2363", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"2371", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"BP Trial: Intensive Control", "OutcomeGroupDescription"=>"Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"BP Trial: Standard Control", "OutcomeGroupDescription"=>"Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.01", "OutcomeAnalysisParamType"=>"Hazard Ratio (HR)", "OutcomeAnalysisCINumSides"=>"2-Sided", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisParamValue"=>"0.59", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisCILowerLimit"=>"0.39", "OutcomeAnalysisCIUpperLimit"=>"0.89", "OutcomeAnalysisPValueComment"=>"P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.", "OutcomeAnalysisStatisticalMethod"=>"Regression, Cox", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"Stroke in the Blood Pressure Trial.", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"4.7 years", "OutcomeMeasureDescription"=>"Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial.", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke."}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"291", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"310", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"2765", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"2753", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Lipid Trial: Fenofibrate", "OutcomeGroupDescription"=>"Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Lipid Trial: Placebo", "OutcomeGroupDescription"=>"Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.32", "OutcomeAnalysisParamType"=>"Hazard Ratio (HR)", "OutcomeAnalysisCINumSides"=>"2-Sided", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisParamValue"=>"0.92", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisCILowerLimit"=>"0.79", "OutcomeAnalysisCIUpperLimit"=>"1.08", "OutcomeAnalysisPValueComment"=>"P-value is adjusted for interim monitoring. A priori significance level was 0.05.", "OutcomeAnalysisGroupDescription"=>"Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.", "OutcomeAnalysisStatisticalMethod"=>"Regression, Cox", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"4.7 years", "OutcomeMeasureDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE."}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"641", "OutcomeMeasurementGroupId"=>"OG000"}, {"OutcomeMeasurementValue"=>"667", "OutcomeMeasurementGroupId"=>"OG001"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"2765", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"2753", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Lipid Trial: Fenofibrate", "OutcomeGroupDescription"=>"Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Lipid Trial: Placebo", "OutcomeGroupDescription"=>"Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day."}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeAnalysisList"=>{"OutcomeAnalysis"=>[{"OutcomeAnalysisPValue"=>"0.30", "OutcomeAnalysisParamType"=>"Hazard Ratio (HR)", "OutcomeAnalysisCINumSides"=>"2-Sided", "OutcomeAnalysisCIPctValue"=>"95", "OutcomeAnalysisParamValue"=>"0.94", "OutcomeAnalysisGroupIdList"=>{"OutcomeAnalysisGroupId"=>["OG000", "OG001"]}, "OutcomeAnalysisCILowerLimit"=>"0.85", "OutcomeAnalysisCIUpperLimit"=>"1.05", "OutcomeAnalysisPValueComment"=>"P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.", "OutcomeAnalysisStatisticalMethod"=>"Regression, Cox", "OutcomeAnalysisNonInferiorityType"=>"Superiority or Other", "OutcomeAnalysisStatisticalComment"=>"Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.", "OutcomeAnalysisTestedNonInferiority"=>"No"}]}, "OutcomeMeasureTitle"=>"First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"4.7 years", "OutcomeMeasureDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants.", "OutcomeMeasureUnitOfMeasure"=>"participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event."}]}}, "ParticipantFlowModule"=>{"FlowGroupList"=>{"FlowGroup"=>[{"FlowGroupId"=>"FG000", "FlowGroupTitle"=>"Glycemia Trial: Intensive Control/BP Trial: Intensive Control", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nBP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."}, {"FlowGroupId"=>"FG001", "FlowGroupTitle"=>"Glycemia Trial: Intensive Control/BP Trial: Standard Control", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nBP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."}, {"FlowGroupId"=>"FG002", "FlowGroupTitle"=>"Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nLipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."}, {"FlowGroupId"=>"FG003", "FlowGroupTitle"=>"Glycemia Trial: Intensive Control/Lipid Trial: Placebo", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nDouble blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."}, {"FlowGroupId"=>"FG004", "FlowGroupTitle"=>"Glycemia Trial: Standard Control/BP Trial: Intensive Control", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nBP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."}, {"FlowGroupId"=>"FG005", "FlowGroupTitle"=>"Glycemia Trial: Standard Control/BP Trial: Standard Control", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nBP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg)."}, {"FlowGroupId"=>"FG006", "FlowGroupTitle"=>"Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nLipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."}, {"FlowGroupId"=>"FG007", "FlowGroupTitle"=>"Glycemia Trial: Standard Control/Lipid Trial: Placebo", "FlowGroupDescription"=>"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.\n\nDouble blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."}]}, "FlowPeriodList"=>{"FlowPeriod"=>[{"FlowPeriodTitle"=>"Overall Study", "FlowMilestoneList"=>{"FlowMilestone"=>[{"FlowMilestoneType"=>"STARTED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"1178"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"1193"}, {"FlowAchievementGroupId"=>"FG002", "FlowAchievementNumSubjects"=>"1374"}, {"FlowAchievementGroupId"=>"FG003", "FlowAchievementNumSubjects"=>"1383"}, {"FlowAchievementGroupId"=>"FG004", "FlowAchievementNumSubjects"=>"1184"}, {"FlowAchievementGroupId"=>"FG005", "FlowAchievementNumSubjects"=>"1178"}, {"FlowAchievementGroupId"=>"FG006", "FlowAchievementNumSubjects"=>"1391"}, {"FlowAchievementGroupId"=>"FG007", "FlowAchievementNumSubjects"=>"1370"}]}}, {"FlowMilestoneType"=>"COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"1016"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"1057"}, {"FlowAchievementGroupId"=>"FG002", "FlowAchievementNumSubjects"=>"1204"}, {"FlowAchievementGroupId"=>"FG003", "FlowAchievementNumSubjects"=>"1205"}, {"FlowAchievementGroupId"=>"FG004", "FlowAchievementNumSubjects"=>"1049"}, {"FlowAchievementGroupId"=>"FG005", "FlowAchievementNumSubjects"=>"1026"}, {"FlowAchievementGroupId"=>"FG006", "FlowAchievementNumSubjects"=>"1242"}, {"FlowAchievementGroupId"=>"FG007", "FlowAchievementNumSubjects"=>"1224"}]}}, {"FlowMilestoneType"=>"NOT COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"162"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"136"}, {"FlowAchievementGroupId"=>"FG002", "FlowAchievementNumSubjects"=>"170"}, {"FlowAchievementGroupId"=>"FG003", "FlowAchievementNumSubjects"=>"178"}, {"FlowAchievementGroupId"=>"FG004", "FlowAchievementNumSubjects"=>"135"}, {"FlowAchievementGroupId"=>"FG005", "FlowAchievementNumSubjects"=>"152"}, {"FlowAchievementGroupId"=>"FG006", "FlowAchievementNumSubjects"=>"149"}, {"FlowAchievementGroupId"=>"FG007", "FlowAchievementNumSubjects"=>"146"}]}}]}, "FlowDropWithdrawList"=>{"FlowDropWithdraw"=>[{"FlowReasonList"=>{"FlowReason"=>[{"FlowReasonGroupId"=>"FG000", "FlowReasonNumSubjects"=>"86"}, {"FlowReasonGroupId"=>"FG001", "FlowReasonNumSubjects"=>"67"}, {"FlowReasonGroupId"=>"FG002", "FlowReasonNumSubjects"=>"112"}, {"FlowReasonGroupId"=>"FG003", "FlowReasonNumSubjects"=>"126"}, {"FlowReasonGroupId"=>"FG004", "FlowReasonNumSubjects"=>"64"}, {"FlowReasonGroupId"=>"FG005", "FlowReasonNumSubjects"=>"77"}, {"FlowReasonGroupId"=>"FG006", "FlowReasonNumSubjects"=>"91"}, {"FlowReasonGroupId"=>"FG007", "FlowReasonNumSubjects"=>"95"}]}, "FlowDropWithdrawType"=>"Death"}, {"FlowReasonList"=>{"FlowReason"=>[{"FlowReasonGroupId"=>"FG000", "FlowReasonNumSubjects"=>"14"}, {"FlowReasonGroupId"=>"FG001", "FlowReasonNumSubjects"=>"14"}, {"FlowReasonGroupId"=>"FG002", "FlowReasonNumSubjects"=>"14"}, {"FlowReasonGroupId"=>"FG003", "FlowReasonNumSubjects"=>"14"}, {"FlowReasonGroupId"=>"FG004", "FlowReasonNumSubjects"=>"15"}, {"FlowReasonGroupId"=>"FG005", "FlowReasonNumSubjects"=>"15"}, {"FlowReasonGroupId"=>"FG006", "FlowReasonNumSubjects"=>"13"}, {"FlowReasonGroupId"=>"FG007", "FlowReasonNumSubjects"=>"14"}]}, "FlowDropWithdrawType"=>"Lost to Follow-up"}, {"FlowReasonList"=>{"FlowReason"=>[{"FlowReasonGroupId"=>"FG000", "FlowReasonNumSubjects"=>"40"}, {"FlowReasonGroupId"=>"FG001", "FlowReasonNumSubjects"=>"27"}, {"FlowReasonGroupId"=>"FG002", "FlowReasonNumSubjects"=>"28"}, {"FlowReasonGroupId"=>"FG003", "FlowReasonNumSubjects"=>"27"}, {"FlowReasonGroupId"=>"FG004", "FlowReasonNumSubjects"=>"30"}, {"FlowReasonGroupId"=>"FG005", "FlowReasonNumSubjects"=>"32"}, {"FlowReasonGroupId"=>"FG006", "FlowReasonNumSubjects"=>"32"}, {"FlowReasonGroupId"=>"FG007", "FlowReasonNumSubjects"=>"21"}]}, "FlowDropWithdrawType"=>"Withdrawal by Subject"}, {"FlowReasonList"=>{"FlowReason"=>[{"FlowReasonGroupId"=>"FG000", "FlowReasonNumSubjects"=>"22"}, {"FlowReasonGroupId"=>"FG001", "FlowReasonNumSubjects"=>"28"}, {"FlowReasonGroupId"=>"FG002", "FlowReasonNumSubjects"=>"16"}, {"FlowReasonGroupId"=>"FG003", "FlowReasonNumSubjects"=>"11"}, {"FlowReasonGroupId"=>"FG004", "FlowReasonNumSubjects"=>"26"}, {"FlowReasonGroupId"=>"FG005", "FlowReasonNumSubjects"=>"28"}, {"FlowReasonGroupId"=>"FG006", "FlowReasonNumSubjects"=>"13"}, {"FlowReasonGroupId"=>"FG007", "FlowReasonNumSubjects"=>"16"}]}, "FlowDropWithdrawType"=>"missed closeout visit"}]}}]}, "FlowRecruitmentDetails"=>"All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites). Recruitment occurred in two phases, from January to June 2001 and from February 2003 to October 2005.", "FlowPreAssignmentDetails"=>"Eligible participants provided evidence of ability to routinely monitor capillary blood sugars from written records or electronic downloads from a self-monitoring blood glucose device (SMBG), or (in cases where such records could not be provided) underwent a 2 to 4-week pre-randomization run-in period to evaluate compliance with SMBG monitoring."}, "BaselineCharacteristicsModule"=>{"BaselineDenomList"=>{"BaselineDenom"=>[{"BaselineDenomUnits"=>"Participants", "BaselineDenomCountList"=>{"BaselineDenomCount"=>[{"BaselineDenomCountValue"=>"5128", "BaselineDenomCountGroupId"=>"BG000"}, {"BaselineDenomCountValue"=>"5123", "BaselineDenomCountGroupId"=>"BG001"}, {"BaselineDenomCountValue"=>"10251", "BaselineDenomCountGroupId"=>"BG002"}]}}]}, "BaselineGroupList"=>{"BaselineGroup"=>[{"BaselineGroupId"=>"BG000", "BaselineGroupTitle"=>"Glycemia Trial: Intensive Control", "BaselineGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals."}, {"BaselineGroupId"=>"BG001", "BaselineGroupTitle"=>"Glycemia Trial: Standard Control", "BaselineGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals."}, {"BaselineGroupId"=>"BG002", "BaselineGroupTitle"=>"Total", "BaselineGroupDescription"=>"Total of all reporting groups"}]}, "BaselineMeasureList"=>{"BaselineMeasure"=>[{"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"62.2", "BaselineMeasurementSpread"=>"6.8", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"62.2", "BaselineMeasurementSpread"=>"6.8", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"62.2", "BaselineMeasurementSpread"=>"6.8", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Age, Continuous", "BaselineMeasureParamType"=>"Mean", "BaselineMeasureUnitOfMeasure"=>"years", "BaselineMeasureDispersionType"=>"Standard Deviation"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Female", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1983", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1969", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"3952", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Male", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"3145", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"3154", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"6299", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Gender", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Hispanic or Latino", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"358", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"379", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"737", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Not Hispanic or Latino", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"4770", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"4744", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"9514", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Unknown or Not Reported", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Ethnicity (NIH/OMB)", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"Nonwhite", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1828", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1819", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"3647", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}, {"BaselineClassTitle"=>"White", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"3300", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"3304", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"6604", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Race/Ethnicity, Customized", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"United States", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"4376", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"4367", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"8743", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}, {"BaselineClassTitle"=>"Canada", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"752", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"756", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"1508", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Region of Enrollment", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"History of CVD event", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1827", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1782", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"3609", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}, {"BaselineClassTitle"=>"No history of CVD event", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"3301", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"3341", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"6642", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Previous cardiovascular disease (CVD) event", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"8.3", "BaselineMeasurementSpread"=>"1.1", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"8.3", "BaselineMeasurementSpread"=>"1.1", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"8.3", "BaselineMeasurementSpread"=>"1.1", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Glycated hemoglobin", "BaselineMeasureParamType"=>"Mean", "BaselineMeasureUnitOfMeasure"=>"percent", "BaselineMeasureDispersionType"=>"Standard Deviation"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"Systolic", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"136.2", "BaselineMeasurementSpread"=>"17.0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"136.5", "BaselineMeasurementSpread"=>"17.2", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"136.4", "BaselineMeasurementSpread"=>"17.1", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}, {"BaselineClassTitle"=>"Diastolic", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"74.8", "BaselineMeasurementSpread"=>"10.6", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"75.0", "BaselineMeasurementSpread"=>"10.7", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"74.9", "BaselineMeasurementSpread"=>"10.7", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Blood pressure", "BaselineMeasureParamType"=>"Mean", "BaselineMeasureUnitOfMeasure"=>"mm Hg", "BaselineMeasureDispersionType"=>"Standard Deviation"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"LDL", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"104.9", "BaselineMeasurementSpread"=>"34.0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"104.9", "BaselineMeasurementSpread"=>"33.8", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"104.9", "BaselineMeasurementSpread"=>"33.9", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}, {"BaselineClassTitle"=>"HDL", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"41.8", "BaselineMeasurementSpread"=>"11.8", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"41.9", "BaselineMeasurementSpread"=>"11.5", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"41.9", "BaselineMeasurementSpread"=>"11.6", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Cholesterol", "BaselineMeasureParamType"=>"Mean", "BaselineMeasureUnitOfMeasure"=>"mg/dL", "BaselineMeasureDispersionType"=>"Standard Deviation"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"156", "BaselineMeasurementGroupId"=>"BG000", "BaselineMeasurementLowerLimit"=>"105", "BaselineMeasurementUpperLimit"=>"230"}, {"BaselineMeasurementValue"=>"154", "BaselineMeasurementGroupId"=>"BG001", "BaselineMeasurementLowerLimit"=>"108", "BaselineMeasurementUpperLimit"=>"226"}, {"BaselineMeasurementValue"=>"155", "BaselineMeasurementGroupId"=>"BG002", "BaselineMeasurementLowerLimit"=>"106", "BaselineMeasurementUpperLimit"=>"228"}]}}]}}]}, "BaselineMeasureTitle"=>"Triglycerides", "BaselineMeasureParamType"=>"Median", "BaselineMeasureUnitOfMeasure"=>"mg/dL", "BaselineMeasureDispersionType"=>"Inter-Quartile Range"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"10", "BaselineMeasurementGroupId"=>"BG000", "BaselineMeasurementLowerLimit"=>"5", "BaselineMeasurementUpperLimit"=>"15"}, {"BaselineMeasurementValue"=>"10", "BaselineMeasurementGroupId"=>"BG001", "BaselineMeasurementLowerLimit"=>"5", "BaselineMeasurementUpperLimit"=>"15"}, {"BaselineMeasurementValue"=>"10", "BaselineMeasurementGroupId"=>"BG002", "BaselineMeasurementLowerLimit"=>"5", "BaselineMeasurementUpperLimit"=>"15"}]}}]}}]}, "BaselineMeasureTitle"=>"Diabetes duration", "BaselineMeasureParamType"=>"Median", "BaselineMeasureUnitOfMeasure"=>"years", "BaselineMeasureDispersionType"=>"Inter-Quartile Range"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Prevention", "DesignInterventionModel"=>"Factorial Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"10251"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2014", "CompletionDateStruct"=>{"CompletionDate"=>"December 2012", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"November 21, 2016", "StudyFirstSubmitDate"=>"October 27, 1999", "ResultsFirstSubmitDate"=>"September 5, 2014", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 22, 2016", "LastUpdatePostDateType"=>"Estimate"}, "ResultsFirstSubmitQCDate"=>"September 5, 2014", "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}, "ResultsFirstPostDateStruct"=>{"ResultsFirstPostDate"=>"September 15, 2014", "ResultsFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2009", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.", "PrimaryOutcomeTimeFrame"=>"4.9 years", "PrimaryOutcomeDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).\n\nIn the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion."}, {"PrimaryOutcomeMeasure"=>"First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.", "PrimaryOutcomeTimeFrame"=>"4.7 years", "PrimaryOutcomeDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial."}, {"PrimaryOutcomeMeasure"=>"First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.", "PrimaryOutcomeTimeFrame"=>"4.7 years", "PrimaryOutcomeDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants."}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Death From Any Cause in the Glycemia Trial.", "SecondaryOutcomeTimeFrame"=>"4.9 years", "SecondaryOutcomeDescription"=>"Time to death from any cause. Secondary measure for Glycemia Trial.\n\nA finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)."}, {"SecondaryOutcomeMeasure"=>"Stroke in the Blood Pressure Trial.", "SecondaryOutcomeTimeFrame"=>"4.7 years", "SecondaryOutcomeDescription"=>"Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial."}, {"SecondaryOutcomeMeasure"=>"First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.", "SecondaryOutcomeTimeFrame"=>"4.7 years", "SecondaryOutcomeDescription"=>"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants."}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Diabetes Mellitus, Non-Insulin-Dependent"]}, "ConditionList"=>{"Condition"=>["Atherosclerosis", "Cardiovascular Diseases", "Hypercholesterolemia", "Hypertension", "Diabetes Mellitus, Type 2", "Diabetes Mellitus", "Coronary Disease"]}}, "ReferencesModule"=>{"AvailIPDList"=>{"AvailIPD"=>[{"AvailIPDId"=>"ACCORD", "AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/accord", "AvailIPDType"=>"Individual Participant Data Set", "AvailIPDComment"=>"NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement."}, {"AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/accord", "AvailIPDType"=>"Study Protocol"}, {"AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/accord", "AvailIPDType"=>"Study Forms"}, {"AvailIPDURL"=>"http://biolincc.nhlbi.nih.gov/studies/accord", "AvailIPDType"=>"Manual of Procedures"}]}, "ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"17599425", "ReferenceType"=>"background", "ReferenceCitation"=>"Cushman WC, Grimm RH Jr, Cutler JA, Evans GW, Capes S, Corson MA, Sadler LS, Alderman MH, Peterson K, Bertoni A, Basile JN; ACCORD Study Group. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol. 2007 Jun 18;99(12A):44i-55i. doi: 10.1016/j.amjcard.2007.03.005. Epub 2007 Apr 16."}, {"ReferencePMID"=>"17599421", "ReferenceType"=>"background", "ReferenceCitation"=>"Williamson JD, Miller ME, Bryan RN, Lazar RM, Coker LH, Johnson J, Cukierman T, Horowitz KR, Murray A, Launer LJ; ACCORD Study Group. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods. Am J Cardiol. 2007 Jun 18;99(12A):112i-122i. doi: 10.1016/j.amjcard.2007.03.029. Epub 2007 Apr 12."}, {"ReferencePMID"=>"17599429", "ReferenceType"=>"background", "ReferenceCitation"=>"Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, Feeney P, Gafni A, Hwang W, Katz LA, Narayan KM, Nwachuku C, O'Connor PJ, Zhang P; ACCORD Study Group. Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. Am J Cardiol. 2007 Jun 18;99(12A):90i-102i. doi: 10.1016/j.amjcard.2007.03.027. 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The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010 Jan 8;340:b4909. doi: 10.1136/bmj.b4909."}, {"ReferencePMID"=>"19898642", "ReferenceType"=>"derived", "ReferenceCitation"=>"Meier M, Hummel M. Cardiovascular disease and intensive glucose control in type 2 diabetes mellitus: moving practice toward evidence-based strategies. Vasc Health Risk Manag. 2009;5:859-71. doi: 10.2147/vhrm.s4808. Epub 2009 Nov 2."}, {"ReferencePMID"=>"27766347", "ReferenceType"=>"derived", "ReferenceCitation"=>"Murray AM, Hsu FC, Williamson JD, Bryan RN, Gerstein HC, Sullivan MD, Miller ME, Leng I, Lovato LL, Launer LJ; Action to Control Cardiovascular Risk in Diabetes Follow-On Memory in Diabetes (ACCORDION MIND) Investigators. ACCORDION MIND: results of the observational extension of the ACCORD MIND randomised trial. Diabetologia. 2017 Jan;60(1):69-80. doi: 10.1007/s00125-016-4118-x. 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Epub 2014 Apr 29."}, {"ReferencePMID"=>"23990163", "ReferenceType"=>"derived", "ReferenceCitation"=>"Barzilay JI, Lovato JF, Murray AM, Williamson J, Ismail-Beigi F, Karl D, Papademetriou V, Launer LJ. Albuminuria and cognitive decline in people with diabetes and normal renal function. Clin J Am Soc Nephrol. 2013 Nov;8(11):1907-14. doi: 10.2215/CJN.11321112. Epub 2013 Aug 29."}, {"ReferencePMID"=>"21958949", "ReferenceType"=>"derived", "ReferenceCitation"=>"Launer LJ, Miller ME, Williamson JD, Lazar RM, Gerstein HC, Murray AM, Sullivan M, Horowitz KR, Ding J, Marcovina S, Lovato LC, Lovato J, Margolis KL, O'Connor P, Lipkin EW, Hirsch J, Coker L, Maldjian J, Sunshine JL, Truwit C, Davatzikos C, Bryan RN; ACCORD MIND investigators. Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lancet Neurol. 2011 Nov;10(11):969-77. doi: 10.1016/S1474-4422(11)70188-0. Epub 2011 Sep 28."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.", "DetailedDescription"=>"BACKGROUND:\n\nCurrently, 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.\n\nType 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.\n\nDESIGN NARRATIVE:\n\nThe three strategies tested in ACCORD included the following: (1) Blood sugar - ACCORD was designed to determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk. The study estimated 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 was designed to determine the effects of lowering blood pressure in the context of good blood sugar control, that is to 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 were assigned to an intervention to improve blood fat levels. This part of the study looked 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\" was used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called \"statins\" was used to lower LDL cholesterol.\n\nAll ACCORD participants received blood sugar treatment from the study. Based on the second trial (Blood Pressure or Lipid) they were assigned to, participants also received their high blood pressure or cholesterol care from the study. Study participants received all medication and treatments related to the study free of charge. Individuals who selected for and consented to participate in the ACCORD study continued to see their personal physician for all other health care.\n\nIn summary, the ACCORD Study was a double 2x2 factorial design with factors consisting of: intensive versus standard glycemic control, intensive versus standard blood pressure control, and blinded fenofibrate or placebo in combination with simvastatin to maintain desirable LDL-C levels. All 10,251 participants were randomized to the glycemic interventions; a subgroup of 4,733 participants who met the blood pressure entry criteria were randomized to the blood pressure interventions in one 2x2 trial; and a distinct subgroup of 5,518 participants who met the lipid entry criteria were randomized to the lipid interventions in the second 2x2 trial. All participants had established type 2 diabetes and were recruited from 77 clinical centers in the United States (64 sites) and Canada (13 sites).\n\nOn February 6, 2008, the National Heart, Lung and Blood Institute (NHLBI) announced that participants in the intensive glycemia treatment would be transitioned to the ACCORD standard glycemic treatment approach due to higher mortality in the intensive treatment group terminating the experimental arm of the Glycemia Trial early. The Blood Pressure and Lipid trials continued as designed to their planned termination in 2009."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"79 years", "MinimumAge"=>"40 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nDiagnosed 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\nFor 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)\nFor 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\nHbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs)"}, "IdentificationModule"=>{"NCTId"=>"NCT00000620", "Acronym"=>"ACCORD", "BriefTitle"=>"Action to Control Cardiovascular Risk in Diabetes (ACCORD)", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OfficialTitle"=>"Action to Control Cardiovascular Risk in Diabetes (ACCORD)", "NCTIdAliasList"=>{"NCTIdAlias"=>["NCT00182910"]}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"123"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"N01HC95178", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95178", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"N01HC95179", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95179", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"N01HC95180", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95180", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"N01HC95181", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95181", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"N01HC95182", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95182", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"N01HC95183", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95183", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"N01HC95184", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/N01HC95184", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"IAA#Y1HC9035", "SecondaryIdType"=>"Other Grant/Funding Number", "SecondaryIdDomain"=>"U.S. Centers for Disease Control"}, {"SecondaryId"=>"IAA#Y1HC1010", "SecondaryIdType"=>"Other Grant/Funding Number", "SecondaryIdDomain"=>"U.S. Centers for Disease Control"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Glycemia Trial: intensive control", "ArmGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Anti-hyperglycemic Agents"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"Glycemia Trial: standard control", "ArmGroupDescription"=>"Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 - 7.9%.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Anti-hyperglycemic Agents"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"BP Trial: intensive control", "ArmGroupDescription"=>"Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Anti-hypertensive Agents"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"BP Trial: standard control", "ArmGroupDescription"=>"Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Anti-hypertensive Agents"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Lipid Trial: fenofibrate", "ArmGroupDescription"=>"Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 in combination with open label simvastatin.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Blinded fenofibrate or placebo plus simvastatin"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Lipid Trial: placebo", "ArmGroupDescription"=>"Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m2 in combination with open label simvastatin.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Blinded fenofibrate or placebo plus simvastatin"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Anti-hyperglycemic Agents", "InterventionType"=>"Drug", "InterventionDescription"=>"Multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals (intensive control <6%; standard control 7.0-7.9%).", "InterventionOtherNameList"=>{"InterventionOtherName"=>["glimepiride (Amaryl)", "metformin (Glucophage)", "repaglinide (Gluconorm, Prandin)", "rosiglitazone (Avandia)", "pioglitazone (Actos)", "human regular insulin (Novolin ge Toronto)", "human NPH (Novolin N)", "human mixed (Novolin 70/30)", "human isophane (Novolin ge NPH)", "human 30/70 (Novolin ge 30/70)", "insulin aspart (NovoRapid, NovoLog)", "insulin detemir (Levemir)", "human regular insulin (Novolin R)", "insulin glargine (Lantus)", "Acarbose"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Glycemia Trial: intensive control", "Glycemia Trial: standard control"]}}, {"InterventionName"=>"Anti-hypertensive Agents", "InterventionType"=>"Drug", "InterventionDescription"=>"Multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg).", "InterventionOtherNameList"=>{"InterventionOtherName"=>["benazepril (Lotensin, Zestril, Altace)", "chlorthalidone (Thalitone)", "metoprolol (Toprol XL)", "diltiazem (Tiazac)", "plendil (Felodipine)", "terazosin (Hytrin)", "candesartan (Atacand)", "valsartan (Diovan)", "furosemide", "reserpine", "hydralazine", "carvedilol (Coreg)", "triamterene / hydrochlorothiazide (Dyazide)", "metoprolol / hydrochlorothiazide(Lopressor HCT)", "benazepril / hydrochlorothiazide (Lotensin HCT)", "lisinopril / hydrochlorothiazide (Zestoretic)", "candesartan / hydrochlorothiazide (Atacand HCT)", "valsartan / hydrochlorothiazide (Diovan HCT)", "amlodipine / benazepril (Lotrel)"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["BP Trial: intensive control", "BP Trial: standard control"]}}, {"InterventionName"=>"Blinded fenofibrate or placebo plus simvastatin", "InterventionType"=>"Drug", "InterventionDescription"=>"Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day.", "InterventionOtherNameList"=>{"InterventionOtherName"=>["fenofibrate (Tricor)"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Lipid Trial: fenofibrate", "Lipid Trial: placebo"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"55404", "LocationCity"=>"Minneapolis", "LocationState"=>"Minnesota", "LocationCountry"=>"United States", "LocationFacility"=>"Minneapolis Medical Research Foundation"}, {"LocationZip"=>"10027", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Columbia University"}, {"LocationZip"=>"27106", "LocationCity"=>"Winston-Salem", "LocationState"=>"North Carolina", "LocationCountry"=>"United States", "LocationFacility"=>"Wake Forest University"}, {"LocationZip"=>"44106", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Case Western Reserve University"}, {"LocationZip"=>"38104", "LocationCity"=>"Memphis", "LocationState"=>"Tennessee", "LocationCountry"=>"United States", "LocationFacility"=>"Veterans Affairs"}, {"LocationZip"=>"98195", "LocationCity"=>"Seattle", "LocationState"=>"Washington", "LocationCountry"=>"United States", "LocationFacility"=>"University of Washington"}, {"LocationCity"=>"Hamilton", "LocationState"=>"Ontario", "LocationCountry"=>"Canada", "LocationFacility"=>"McMaster University"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Denise Simons-Morton, MD, PhD", "OverallOfficialRole"=>"Study Director", "OverallOfficialAffiliation"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, {"OverallOfficialName"=>"William Friedewald, MD", "OverallOfficialRole"=>"Study Chair", "OverallOfficialAffiliation"=>"Columbia University, New York, NY"}, {"OverallOfficialName"=>"Robert Byington, PhD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Wake Forest University, Winston-Salem, NC"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"National Institute on Aging (NIA)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"National Eye Institute (NEI)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"Centers for Disease Control and Prevention", "CollaboratorClass"=>"FED"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
Trial Information
Current as of December 10, 2023
Completed
Keywords
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 ...
Gender
All
Eligibility 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)
Attachments
4.5 MB
4.5 MB
About company
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Seattle, Washington, United States
Cleveland, Ohio, United States
Winston Salem, North Carolina, United States
Minneapolis, Minnesota, United States
Memphis, Tennessee, United States
Hamilton, Ontario, Canada
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
4.9 years
Reviews (48)
All reviews come from applied patients

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