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Trial record 1 of 1 for:    NCT00000620
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Action to Control Cardiovascular Risk in Diabetes (ACCORD)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Robert P. Byington, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00000620
First received: October 27, 1999
Last updated: September 5, 2014
Last verified: September 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  
Number of Participants  
[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:


Responsible Party: Robert P. Byington, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00000620     History of Changes
Other Study ID Numbers: 123, N01HC95178, N01HC95179, N01HC95180, N01HC95181, N01HC95182, N01HC95183, N01HC95184, IAA#Y1HC9035, IAA#Y1HC1010
Study First Received: October 27, 1999
Results First Received: September 5, 2014
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration