Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00542178
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : November 26, 2013
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Diabetic Retinopathy
Interventions Drug: Hypoglycemic Agents
Drug: Standard glycemia control
Drug: Intensive BP treatment
Drug: Standard BP control
Drug: Fenofibrate
Drug: Simvastatin
Drug: Placebo
Enrollment 3472
Recruitment Details Recruitment for the ACCORD Eye study was restricted to participants recruited as part of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The ACCORD Eye study began in October 2003, with 3472 participants enrolled by February 2006.
Pre-assignment Details All participants were enrolled in either the intensive or standard glycemia control arms. In addition to inclusion in the glycemia control part of the trial, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo).
Arm/Group Title Intensive Glycemia Control & Intensive Blood Pressure Control Standard Glycemia Control & Intensive Blood Pressure Control Intensive Glycemia Control & Standard Blood Pressure Control Standard Glycemia Control & Standard Blood Pressure Control Intensive Glycemia Control & Fibrate Standard Glycemia Control & Fibrate Intensive Glycemia Control & Fibrate Placebo Standard Glycemia Control & Fibrate Placebo
Hide Arm/Group Description

Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%

Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg

Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%

Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg

Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%

Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg

Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%

Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg

Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%

Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d

Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%

Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d

Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%

Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d

Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%

Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d

Period Title: Overall Study
Started 390 412 382 370 464 495 493 466
Completed 315 332 308 308 400 406 406 381
Not Completed 75 80 74 62 64 89 87 85
Reason Not Completed
did not complete year 4 follow-up             75             80             74             62             64             89             87             85
Arm/Group Title Intensive Glycemia Control Standard Glycemia Control Intensive BP Control Standard BP Control Fibrate Fibrate Placebo Total
Hide Arm/Group Description A strategy of intensive glycemia treatment to HbA1c less than 6% A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% A strategy of BP treatment for SBP less than 120 mm Hg A strategy of BP treatment for SBP less than 140 mm Hg Blinded fenofibrate + simvastatin 20-40 mg/d Blinded placebo + simvastatin 20-40 mg/d Total of all reporting groups
Overall Number of Baseline Participants 1429 1427 647 616 806 787 5712
Hide Baseline Analysis Population Description
All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1429 participants 1427 participants 647 participants 616 participants 806 participants 787 participants 5712 participants
61.6  (6.4) 61.5  (6.3) 61.3  (6.1) 61.5  (6.6) 61.9  (6.2) 61.5  (6.5) 61.6  (6.3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
Female
538
  37.6%
552
  38.7%
1090
  38.2%
Male
891
  62.4%
875
  61.3%
1766
  61.8%
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
Female
310
  47.9%
279
  45.3%
247
  30.6%
254
  32.3%
1090
  38.2%
Male
337
  52.1%
337
  54.7%
559
  69.4%
533
  67.7%
1766
  61.8%
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Duration of diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Year
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
9.8  (7.1) 10.1  (7.2) 10.0  (7.1)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
10.1  (7.0) 10.3  (7.5) 9.7  (6.8) 9.8  (7.2) 10.0  (7.1)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Previous cardiovascular event   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
Previous cardiovascular event
452
  31.6%
443
  31.0%
895
  31.3%
No previous cardiovascular event
977
  68.4%
984
  69.0%
1961
  68.7%
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
Previous cardiovascular event
180
  27.8%
197
  32.0%
263
  32.6%
255
  32.4%
895
  31.3%
No previous cardiovascular event
467
  72.2%
419
  68.0%
543
  67.4%
532
  67.6%
1961
  68.7%
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Race   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
Nonwhite race
427
  29.9%
433
  30.3%
860
  30.1%
White race
1002
  70.1%
994
  69.7%
1996
  69.9%
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
Nonwhite race
203
  31.4%
201
  32.6%
222
  27.5%
234
  29.7%
860
  30.1%
White race
444
  68.6%
415
  67.4%
584
  72.5%
553
  70.3%
1996
  69.9%
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Glycated hemoglobin   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
8.2  (1.0) 8.3  (1.0) 8.2  (1.0)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
8.4  (1.1) 8.2  (1.0) 8.2  (1.0) 8.2  (1.0) 8.2  (1.0)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Cholesterol (HDL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
42.0  (11.4) 41.9  (11.1) 41.9  (11.3)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
46.3  (12.8) 46.31  (13.8) 38.6  (7.8) 38.5  (7.9) 41.9  (11.3)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Cholesterol (LDL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
100.8  (33.4) 100.7  (32.1) 100.7  (32.7)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
107.4  (37.0) 104.1  (33.5) 96.5  (29.7) 97.0  (30.1) 100.7  (32.7)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Triglycerides   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
196.1  (157.8) 194  (167.3) 195.1  (162.6)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
200.7  (175.5) 204.7  (240.3) 190.1  (111.3) 187.9  (112.4) 195.1  (162.6)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Systolic Blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
134.3  (16.6) 134.7  (17.4) 134.5  (17.0)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
138.0  (16.7) 139.0  (14.7) 131.5  (17.0) 131.1  (17.5) 134.5  (17.0)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Diastolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
74.9  (10.3) 75.0  (10.6) 74.9  (10.5)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
76.3  (10.5) 76.8  (9.9) 73.7  (10.5) 73.6  (10.5) 74.9  (10.5)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Urinary albumin:creatinine ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Albumin (mg/dL): creatinin (g/dL)
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
69.5  (2228.9) 74.0  (275.3) 71.8  (253.1)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
62.5  (197.6) 79.2  (269.9) 62.3  (180.2) 83.2  (331.5) 71.8  (253.1)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
32.4  (5.5) 32.5  (5.4) 32.4  (5.5)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
32.7  (5.7) 32.2  (5.3) 32.3  (5.5) 32.6  (5.4) 32.4  (5.5)
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Visual acuity   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Letters
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
75.9  (10.4) 75.9  (10.0) 75.9  (10.2)
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
75.6  (10.3) 75.5  (10.2) 76.2  (9.7) 76.2  (10.7) 75.9  (10.2)
[1]
Measure Description: Visual acuity is defined as a mean of the acuity scores for both eyes of 74 to 78 letters (the approximate Snellen equivalent of 20/30)
[2]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Smoking status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
Never smoked
581
  40.7%
607
  42.5%
1188
  41.6%
Former Smoker
657
  46.0%
623
  43.7%
1280
  44.8%
Current Smoker
191
  13.4%
196
  13.7%
387
  13.6%
Missing
0
   0.0%
1
   0.1%
1
   0.0%
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
Never smoked
279
  43.1%
263
  42.7%
313
  38.8%
333
  42.3%
1188
  41.6%
Former Smoker
279
  43.1%
276
  44.8%
373
  46.3%
352
  44.7%
1280
  44.8%
Current Smoker
89
  13.8%
77
  12.5%
119
  14.8%
102
  13.0%
387
  13.6%
Missing
0
   0.0%
0
   0.0%
1
   0.1%
0
   0.0%
1
   0.0%
[1]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
Severity of Diabetic Retinopathy   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Glycemic Control Study Number Analyzed 1429 participants 1427 participants 0 participants 0 participants 0 participants 0 participants 2856 participants
None
729
  51.0%
721
  50.5%
1450
  50.8%
Mild
241
  16.9%
277
  19.4%
518
  18.1%
Moderate Nonproliferative Diabetic Retinopathy
443
  31.0%
404
  28.3%
847
  29.7%
Severe Nonproliferative Diabetic Retinopathy
5
   0.3%
5
   0.4%
10
   0.4%
Proliferative diabetic retinopathy
10
   0.7%
19
   1.3%
29
   1.0%
Missing
1
   0.1%
1
   0.1%
2
   0.1%
Blood Pressure and Lipid Studies Number Analyzed 0 participants 0 participants 647 participants 616 participants 806 participants 787 participants 2856 participants
None
328
  50.7%
295
  47.9%
429
  53.2%
398
  50.6%
1450
  50.8%
Mild
105
  16.2%
117
  19.0%
141
  17.5%
155
  19.7%
518
  18.1%
Moderate Nonproliferative Diabetic Retinopathy
195
  30.1%
198
  32.1%
230
  28.5%
224
  28.5%
847
  29.7%
Severe Nonproliferative Diabetic Retinopathy
3
   0.5%
1
   0.2%
2
   0.2%
4
   0.5%
10
   0.4%
Proliferative diabetic retinopathy
14
   2.2%
5
   0.8%
4
   0.5%
6
   0.8%
29
   1.0%
Missing
2
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.1%
[1]
Measure Description: Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.
[2]
Measure Analysis Population Description: All participants were enrolled in either the intensive or standard glycemia control arms. In addition, participants were included as either part of the blood pressure trial (randomized to intensive or standard) OR the lipid trial (fibrate or fibrate placebo). We completed analysis on participants for whom we had baseline and follow-up data.
1.Primary Outcome
Title Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy
Hide Description Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.
Time Frame Measured at Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses.
Arm/Group Title Intensive Glycemia Control Standard Glycemia Control Intensive Blood Pressure Control Standard Blood Pressure Control Fenofibrate + Simvastatin Therapy Placebo + Simvastatin Therapy
Hide Arm/Group Description:
Strategy of intensive glycemia treatment to HbA1c less than 6%
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
A strategy of BP treatment for SBP less than 120 mmHg
Strategy of BP treatment for SBP less than 140 mmHg
Blinded fenofibrate + simvastatin 20-40 mg/d
Blinded placebo + simvastatin 20-40 mg/d
Overall Number of Participants Analyzed 1429 1427 647 616 806 787
Measure Type: Number
Unit of Measure: participants
104 149 67 54 52 80
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Glycemia Control, Standard Glycemia Control
Comments Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.51 to 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensive Blood Pressure Control, Standard Blood Pressure Control
Comments Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Regression, Logistic
Comments Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.84 to 1.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fenofibrate + Simvastatin Therapy, Placebo + Simvastatin Therapy
Comments Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Regression, Logistic
Comments Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.42 to 0.87
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Loss of Visual Acuity
Hide Description [Not Specified]
Time Frame Measured at Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity.
Arm/Group Title Intensive Glycemia Control Standard Glycemia Control Intensive Blood Pressure Control Standard Blood Pressure Control Fenofibrate + Simvastatin Therapy Placebo + Simvastatin Therapy
Hide Arm/Group Description:
Strategy of intensive glycemia treatment to HbA1c less than 6%
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
A strategy of BP treatment for SBP less than 120 mmHg
Strategy of BP treatment for SBP less than 140 mmHg
Blinded fenofibrate + simvastatin 20-40 mg/d
Blinded placebo + simvastatin 20-40 mg/d
Overall Number of Participants Analyzed 3466 3511 1629 1617 1883 1848
Measure Type: Count of Participants
Unit of Measure: Participants
744
  21.5%
752
  21.4%
367
  22.5%
382
  23.6%
354
  18.8%
393
  21.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Glycemia Control, Standard Glycemia Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.997
Confidence Interval (2-Sided) 95%
0.901 to 1.104
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensive Blood Pressure Control, Standard Blood Pressure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.952
Confidence Interval (2-Sided) 95%
0.825 to 1.099
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fenofibrate + Simvastatin Therapy, Placebo + Simvastatin Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.880
Confidence Interval (2-Sided) 95%
0.762 to 1.016
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Cataract Extraction
Hide Description [Not Specified]
Time Frame Measured at Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction.
Arm/Group Title Intensive Glycemia Control Standard Glycemia Control Intensive Blood Pressure Control Standard Blood Pressure Control Fenofibrate + Simvastatin Therapy Placebo + Simvastatin Therapy
Hide Arm/Group Description:
Strategy of intensive glycemia treatment to HbA1c less than 6%
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
A strategy of BP treatment for SBP less than 120 mmHg
Strategy of BP treatment for SBP less than 140 mmHg
Blinded fenofibrate + simvastatin 20-40 mg/d
Blinded placebo + simvastatin 20-40 mg/d
Overall Number of Participants Analyzed 4361 4405 2053 2039 2333 2341
Measure Type: Count of Participants
Unit of Measure: Participants
547
  12.5%
623
  14.1%
266
  13.0%
300
  14.7%
305
  13.1%
299
  12.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Glycemia Control, Standard Glycemia Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0355
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.884
Confidence Interval (2-Sided) 95%
0.788 to 0.992
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensive Blood Pressure Control, Standard Blood Pressure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.891
Confidence Interval (2-Sided) 95%
0.755 to 1.051
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fenofibrate + Simvastatin Therapy, Placebo + Simvastatin Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.015
Confidence Interval (2-Sided) 95%
0.865 to 1.190
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Development or Progression of Macular Edema
Hide Description [Not Specified]
Time Frame Measured at Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensive Glycemia Control Standard Glycemia Control Intensive Blood Pressure Control Standard Blood Pressure Control Fenofibrate + Simvastatin Therapy Placebo + Simvastatin Therapy
Hide Arm/Group Description:
Strategy of intensive glycemia treatment to HbA1c less than 6%
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
A strategy of BP treatment for SBP less than 120 mmHg
Strategy of BP treatment for SBP less than 140 mmHg
Blinded fenofibrate + simvastatin 20-40 mg/d
Blinded placebo + simvastatin 20-40 mg/d
Overall Number of Participants Analyzed 1413 1399 633 609 791 779
Measure Type: Count of Participants
Unit of Measure: Participants
44
   3.1%
40
   2.9%
18
   2.8%
20
   3.3%
24
   3.0%
22
   2.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Glycemia Control, Standard Glycemia Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.71 to 1.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intensive Blood Pressure Control, Standard Blood Pressure Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.44 to 1.63
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fenofibrate + Simvastatin Therapy, Placebo + Simvastatin Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.60 to 1.96
Estimation Comments [Not Specified]
Time Frame Entire duration of the study
Adverse Event Reporting Description Adverse events were collected as part of the ACCORD main trial (NCT00000620). No adverse events were collected as part of the ACCORD-Eye Study.
 
Arm/Group Title Intensive Glycemia Control Standard Glycemia Control Intensive BP Control Standard BP Control Fibrate Fibrate Placebo
Hide Arm/Group Description A strategy of intensive glycemia treatment to HbA1c less than 6% A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% A strategy of BP treatment for SBP less than 120 mm Hg A strategy of BP treatment for SBP less than 140 mm Hg Blinded fenofibrate + simvastatin 20-40 mg/d Blinded placebo + simvastatin 20-40 mg/d
All-Cause Mortality
Intensive Glycemia Control Standard Glycemia Control Intensive BP Control Standard BP Control Fibrate Fibrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Glycemia Control Standard Glycemia Control Intensive BP Control Standard BP Control Fibrate Fibrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intensive Glycemia Control Standard Glycemia Control Intensive BP Control Standard BP Control Fibrate Fibrate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0 
The glycemia trial was stopped early, potentially underestimating the reported effect of glycemia treatment on diabetic retinopathy.
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: Dr. Walter Ambrosius, PhD
Organization: Wake Forest University School of Medicine
Phone: 336-716-6281
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00542178     History of Changes
Other Study ID Numbers: 509
N01HC95178-19 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2007
First Posted: October 10, 2007
Results First Submitted: April 27, 2012
Results First Posted: November 26, 2013
Last Update Posted: July 24, 2018