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Action to Control Cardiovascular Risk in Diabetes (ACCORD) (ACCORD)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Aging (NIA)
National Eye Institute (NEI)
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000620
First received: October 27, 1999
Last updated: November 21, 2016
Last verified: November 2014
Results First Received: September 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Atherosclerosis
Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Diabetes Mellitus, Type 2
Diabetes Mellitus
Coronary Disease
Interventions: Drug: Anti-hyperglycemic Agents
Drug: Anti-hypertensive Agents
Drug: Blinded fenofibrate or placebo plus simvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Glycemia Trial: Intensive Control/BP Trial: Intensive Control

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.

BP 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.

Glycemia Trial: Intensive Control/BP Trial: Standard Control

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.

BP 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.

Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate

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.

Lipid 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.

Glycemia Trial: Intensive Control/Lipid Trial: Placebo

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.

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/1.73m^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.

Glycemia Trial: Standard Control/BP Trial: Intensive Control

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.

BP 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.

Glycemia Trial: Standard Control/BP Trial: Standard Control

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.

BP 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).

Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate

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.

Lipid 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.

Glycemia Trial: Standard Control/Lipid Trial: Placebo

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.

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/1.73m^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.


Participant Flow:   Overall Study
    Glycemia Trial: Intensive Control/BP Trial: Intensive Control   Glycemia Trial: Intensive Control/BP Trial: Standard Control   Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate   Glycemia Trial: Intensive Control/Lipid Trial: Placebo   Glycemia Trial: Standard Control/BP Trial: Intensive Control   Glycemia Trial: Standard Control/BP Trial: Standard Control   Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate   Glycemia Trial: Standard Control/Lipid Trial: Placebo
STARTED   1178   1193   1374   1383   1184   1178   1391   1370 
COMPLETED   1016   1057   1204   1205   1049   1026   1242   1224 
NOT COMPLETED   162   136   170   178   135   152   149   146 
Death                86                67                112                126                64                77                91                95 
Lost to Follow-up                14                14                14                14                15                15                13                14 
Withdrawal by Subject                40                27                28                27                30                32                32                21 
missed closeout visit                22                28                16                11                26                28                13                16 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glycemia Trial: Intensive Control 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.
Glycemia Trial: Standard Control 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.
Total Total of all reporting groups

Baseline Measures
   Glycemia Trial: Intensive Control   Glycemia Trial: Standard Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 5128   5123   10251 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (6.8)   62.2  (6.8)   62.2  (6.8) 
Gender 
[Units: Participants]
     
Female   1983   1969   3952 
Male   3145   3154   6299 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   358   379   737 
Not Hispanic or Latino   4770   4744   9514 
Unknown or Not Reported   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Nonwhite   1828   1819   3647 
White   3300   3304   6604 
Region of Enrollment 
[Units: Participants]
     
United States   4376   4367   8743 
Canada   752   756   1508 
Previous cardiovascular disease (CVD) event 
[Units: Participants]
     
History of CVD event   1827   1782   3609 
No history of CVD event   3301   3341   6642 
Glycated hemoglobin 
[Units: Percent]
Mean (Standard Deviation)
 8.3  (1.1)   8.3  (1.1)   8.3  (1.1) 
Blood pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
     
Systolic   136.2  (17.0)   136.5  (17.2)   136.4  (17.1) 
Diastolic   74.8  (10.6)   75.0  (10.7)   74.9  (10.7) 
Cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
     
LDL   104.9  (34.0)   104.9  (33.8)   104.9  (33.9) 
HDL   41.8  (11.8)   41.9  (11.5)   41.9  (11.6) 
Triglycerides 
[Units: mg/dL]
Median (Inter-Quartile Range)
 156 
 (105 to 230) 
 154 
 (108 to 226) 
 155 
 (106 to 228) 
Diabetes duration 
[Units: Years]
Median (Inter-Quartile Range)
 10 
 (5 to 15) 
 10 
 (5 to 15) 
 10 
 (5 to 15) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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.   [ Time Frame: 4.9 years ]

2.  Primary:   First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.   [ Time Frame: 4.7 years ]

3.  Primary:   First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.   [ Time Frame: 4.7 years ]

4.  Secondary:   Death From Any Cause in the Glycemia Trial.   [ Time Frame: 4.9 years ]

5.  Secondary:   Stroke in the Blood Pressure Trial.   [ Time Frame: 4.7 years ]

6.  Secondary:   First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.   [ Time Frame: 4.7 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tim Craven / Senior Biostatistician
Organization: Wake Forest School of Medicine
phone: 336-716-6109
e-mail: tcraven@wakehealth.edu


Publications of Results:
Other Publications:

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


Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000620     History of Changes
Obsolete Identifiers: NCT00182910
Other Study ID Numbers: 123
N01HC95178 ( US NIH Grant/Contract Award Number )
N01HC95179 ( US NIH Grant/Contract Award Number )
N01HC95180 ( US NIH Grant/Contract Award Number )
N01HC95181 ( US NIH Grant/Contract Award Number )
N01HC95182 ( US NIH Grant/Contract Award Number )
N01HC95183 ( US NIH Grant/Contract Award Number )
N01HC95184 ( US NIH Grant/Contract Award Number )
IAA#Y1HC9035 ( Other Grant/Funding Number: U.S. Centers for Disease Control )
IAA#Y1HC1010 ( Other Grant/Funding Number: U.S. Centers for Disease Control )
Study First Received: October 27, 1999
Results First Received: September 5, 2014
Last Updated: November 21, 2016
Health Authority: United States: Food and Drug Administration