Trial Outcomes & Findings for Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study) (NCT NCT00542178)
NCT ID: NCT00542178
Last Updated: 2018-07-24
Results Overview
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.
COMPLETED
PHASE3
3472 participants
Measured at Year 4
2018-07-24
Participant Flow
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.
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).
Participant milestones
| Measure |
Intensive Glycemia Control & Intensive Blood Pressure Control
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 & Intensive Blood Pressure Control
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 & Standard Blood Pressure Control
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 & Standard Blood Pressure Control
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 & Fibrate
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 & Fibrate
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 & Fibrate Placebo
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 & Fibrate Placebo
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
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
390
|
412
|
382
|
370
|
464
|
495
|
493
|
466
|
|
Overall Study
COMPLETED
|
315
|
332
|
308
|
308
|
400
|
406
|
406
|
381
|
|
Overall Study
NOT COMPLETED
|
75
|
80
|
74
|
62
|
64
|
89
|
87
|
85
|
Reasons for withdrawal
| Measure |
Intensive Glycemia Control & Intensive Blood Pressure Control
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 & Intensive Blood Pressure Control
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 & Standard Blood Pressure Control
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 & Standard Blood Pressure Control
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 & Fibrate
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 & Fibrate
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 & Fibrate Placebo
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 & Fibrate Placebo
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
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
did not complete year 4 follow-up
|
75
|
80
|
74
|
62
|
64
|
89
|
87
|
85
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Intensive Glycemia Control
n=1429 Participants
A strategy of intensive glycemia treatment to HbA1c less than 6%
|
Standard Glycemia Control
n=1427 Participants
A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
|
Intensive BP Control
n=647 Participants
A strategy of BP treatment for SBP less than 120 mm Hg
|
Standard BP Control
n=616 Participants
A strategy of BP treatment for SBP less than 140 mm Hg
|
Fibrate
n=806 Participants
Blinded fenofibrate + simvastatin 20-40 mg/d
|
Fibrate Placebo
n=787 Participants
Blinded placebo + simvastatin 20-40 mg/d
|
Total
n=5712 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 6.4 • n=1429 Participants
|
61.5 years
STANDARD_DEVIATION 6.3 • n=1427 Participants
|
61.3 years
STANDARD_DEVIATION 6.1 • n=647 Participants
|
61.5 years
STANDARD_DEVIATION 6.6 • n=616 Participants
|
61.9 years
STANDARD_DEVIATION 6.2 • n=806 Participants
|
61.5 years
STANDARD_DEVIATION 6.5 • n=787 Participants
|
61.6 years
STANDARD_DEVIATION 6.3 • n=5712 Participants
|
|
Sex: Female, Male
Glycemic Control Study · Female
|
538 Participants
n=1429 Participants • 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.
|
552 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1090 Participants
n=2856 Participants • 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.
|
|
Sex: Female, Male
Glycemic Control Study · Male
|
891 Participants
n=1429 Participants • 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.
|
875 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1766 Participants
n=2856 Participants • 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.
|
|
Sex: Female, Male
Blood Pressure and Lipid Studies · Female
|
—
|
—
|
310 Participants
n=647 Participants • 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.
|
279 Participants
n=616 Participants • 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.
|
247 Participants
n=806 Participants • 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.
|
254 Participants
n=787 Participants • 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.
|
1090 Participants
n=2856 Participants • 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.
|
|
Sex: Female, Male
Blood Pressure and Lipid Studies · Male
|
—
|
—
|
337 Participants
n=647 Participants • 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.
|
337 Participants
n=616 Participants • 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.
|
559 Participants
n=806 Participants • 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.
|
533 Participants
n=787 Participants • 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.
|
1766 Participants
n=2856 Participants • 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
Glycemic Control Study
|
9.8 year
STANDARD_DEVIATION 7.1 • n=1429 Participants • 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.
|
10.1 year
STANDARD_DEVIATION 7.2 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
10.0 year
STANDARD_DEVIATION 7.1 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
10.1 year
STANDARD_DEVIATION 7.0 • n=647 Participants • 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.
|
10.3 year
STANDARD_DEVIATION 7.5 • n=616 Participants • 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.
|
9.7 year
STANDARD_DEVIATION 6.8 • n=806 Participants • 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.
|
9.8 year
STANDARD_DEVIATION 7.2 • n=787 Participants • 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.
|
10.0 year
STANDARD_DEVIATION 7.1 • n=2856 Participants • 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
Glycemic Control Study · Previous cardiovascular event
|
452 Participants
n=1429 Participants • 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.
|
443 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
895 Participants
n=2856 Participants • 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
Glycemic Control Study · No previous cardiovascular event
|
977 Participants
n=1429 Participants • 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.
|
984 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1961 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Previous cardiovascular event
|
—
|
—
|
180 Participants
n=647 Participants • 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.
|
197 Participants
n=616 Participants • 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.
|
263 Participants
n=806 Participants • 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.
|
255 Participants
n=787 Participants • 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.
|
895 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · No previous cardiovascular event
|
—
|
—
|
467 Participants
n=647 Participants • 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.
|
419 Participants
n=616 Participants • 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.
|
543 Participants
n=806 Participants • 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.
|
532 Participants
n=787 Participants • 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.
|
1961 Participants
n=2856 Participants • 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
Glycemic Control Study · Nonwhite race
|
427 Participants
n=1429 Participants • 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.
|
433 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
860 Participants
n=2856 Participants • 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
Glycemic Control Study · White race
|
1002 Participants
n=1429 Participants • 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.
|
994 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1996 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Nonwhite race
|
—
|
—
|
203 Participants
n=647 Participants • 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.
|
201 Participants
n=616 Participants • 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.
|
222 Participants
n=806 Participants • 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.
|
234 Participants
n=787 Participants • 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.
|
860 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · White race
|
—
|
—
|
444 Participants
n=647 Participants • 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.
|
415 Participants
n=616 Participants • 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.
|
584 Participants
n=806 Participants • 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.
|
553 Participants
n=787 Participants • 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.
|
1996 Participants
n=2856 Participants • 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
Glycemic Control Study
|
8.2 percent
STANDARD_DEVIATION 1.0 • n=1429 Participants • 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.
|
8.3 percent
STANDARD_DEVIATION 1.0 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
8.2 percent
STANDARD_DEVIATION 1.0 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
8.4 percent
STANDARD_DEVIATION 1.1 • n=647 Participants • 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.
|
8.2 percent
STANDARD_DEVIATION 1.0 • n=616 Participants • 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.
|
8.2 percent
STANDARD_DEVIATION 1.0 • n=806 Participants • 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.
|
8.2 percent
STANDARD_DEVIATION 1.0 • n=787 Participants • 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.
|
8.2 percent
STANDARD_DEVIATION 1.0 • n=2856 Participants • 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)
Glycemic Control Study
|
42.0 mg/dl
STANDARD_DEVIATION 11.4 • n=1429 Participants • 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.
|
41.9 mg/dl
STANDARD_DEVIATION 11.1 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
41.9 mg/dl
STANDARD_DEVIATION 11.3 • n=2856 Participants • 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)
Blood Pressure and Lipid Studies
|
—
|
—
|
46.3 mg/dl
STANDARD_DEVIATION 12.8 • n=647 Participants • 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.
|
46.31 mg/dl
STANDARD_DEVIATION 13.8 • n=616 Participants • 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.
|
38.6 mg/dl
STANDARD_DEVIATION 7.8 • n=806 Participants • 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.
|
38.5 mg/dl
STANDARD_DEVIATION 7.9 • n=787 Participants • 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.
|
41.9 mg/dl
STANDARD_DEVIATION 11.3 • n=2856 Participants • 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)
Glycemic Control Study
|
100.8 mg/dl
STANDARD_DEVIATION 33.4 • n=1429 Participants • 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.
|
100.7 mg/dl
STANDARD_DEVIATION 32.1 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
100.7 mg/dl
STANDARD_DEVIATION 32.7 • n=2856 Participants • 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)
Blood Pressure and Lipid Studies
|
—
|
—
|
107.4 mg/dl
STANDARD_DEVIATION 37.0 • n=647 Participants • 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.
|
104.1 mg/dl
STANDARD_DEVIATION 33.5 • n=616 Participants • 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.
|
96.5 mg/dl
STANDARD_DEVIATION 29.7 • n=806 Participants • 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.
|
97.0 mg/dl
STANDARD_DEVIATION 30.1 • n=787 Participants • 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.
|
100.7 mg/dl
STANDARD_DEVIATION 32.7 • n=2856 Participants • 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
Glycemic Control Study
|
196.1 mg/dl
STANDARD_DEVIATION 157.8 • n=1429 Participants • 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.
|
194 mg/dl
STANDARD_DEVIATION 167.3 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
195.1 mg/dl
STANDARD_DEVIATION 162.6 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
200.7 mg/dl
STANDARD_DEVIATION 175.5 • n=647 Participants • 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.
|
204.7 mg/dl
STANDARD_DEVIATION 240.3 • n=616 Participants • 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.
|
190.1 mg/dl
STANDARD_DEVIATION 111.3 • n=806 Participants • 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.
|
187.9 mg/dl
STANDARD_DEVIATION 112.4 • n=787 Participants • 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.
|
195.1 mg/dl
STANDARD_DEVIATION 162.6 • n=2856 Participants • 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
Glycemic Control Study
|
134.3 mm Hg
STANDARD_DEVIATION 16.6 • n=1429 Participants • 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.
|
134.7 mm Hg
STANDARD_DEVIATION 17.4 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
134.5 mm Hg
STANDARD_DEVIATION 17.0 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
138.0 mm Hg
STANDARD_DEVIATION 16.7 • n=647 Participants • 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.
|
139.0 mm Hg
STANDARD_DEVIATION 14.7 • n=616 Participants • 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.
|
131.5 mm Hg
STANDARD_DEVIATION 17.0 • n=806 Participants • 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.
|
131.1 mm Hg
STANDARD_DEVIATION 17.5 • n=787 Participants • 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.
|
134.5 mm Hg
STANDARD_DEVIATION 17.0 • n=2856 Participants • 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
Glycemic Control Study
|
74.9 mm Hg
STANDARD_DEVIATION 10.3 • n=1429 Participants • 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.
|
75.0 mm Hg
STANDARD_DEVIATION 10.6 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
74.9 mm Hg
STANDARD_DEVIATION 10.5 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
76.3 mm Hg
STANDARD_DEVIATION 10.5 • n=647 Participants • 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.
|
76.8 mm Hg
STANDARD_DEVIATION 9.9 • n=616 Participants • 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.
|
73.7 mm Hg
STANDARD_DEVIATION 10.5 • n=806 Participants • 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.
|
73.6 mm Hg
STANDARD_DEVIATION 10.5 • n=787 Participants • 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.
|
74.9 mm Hg
STANDARD_DEVIATION 10.5 • n=2856 Participants • 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
Glycemic Control Study
|
69.5 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 2228.9 • n=1429 Participants • 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.
|
74.0 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 275.3 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
71.8 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 253.1 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
62.5 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 197.6 • n=647 Participants • 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.
|
79.2 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 269.9 • n=616 Participants • 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.
|
62.3 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 180.2 • n=806 Participants • 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.
|
83.2 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 331.5 • n=787 Participants • 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.
|
71.8 albumin (mg/dL): creatinin (g/dL)
STANDARD_DEVIATION 253.1 • n=2856 Participants • 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
Glycemic Control Study
|
32.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=1429 Participants • 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.
|
32.5 kg/m^2
STANDARD_DEVIATION 5.4 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
32.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
32.7 kg/m^2
STANDARD_DEVIATION 5.7 • n=647 Participants • 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.
|
32.2 kg/m^2
STANDARD_DEVIATION 5.3 • n=616 Participants • 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.
|
32.3 kg/m^2
STANDARD_DEVIATION 5.5 • n=806 Participants • 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.
|
32.6 kg/m^2
STANDARD_DEVIATION 5.4 • n=787 Participants • 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.
|
32.4 kg/m^2
STANDARD_DEVIATION 5.5 • n=2856 Participants • 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
Glycemic Control Study
|
75.9 letters
STANDARD_DEVIATION 10.4 • n=1429 Participants • 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.
|
75.9 letters
STANDARD_DEVIATION 10.0 • n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
75.9 letters
STANDARD_DEVIATION 10.2 • n=2856 Participants • 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
Blood Pressure and Lipid Studies
|
—
|
—
|
75.6 letters
STANDARD_DEVIATION 10.3 • n=647 Participants • 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.
|
75.5 letters
STANDARD_DEVIATION 10.2 • n=616 Participants • 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.
|
76.2 letters
STANDARD_DEVIATION 9.7 • n=806 Participants • 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.
|
76.2 letters
STANDARD_DEVIATION 10.7 • n=787 Participants • 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.
|
75.9 letters
STANDARD_DEVIATION 10.2 • n=2856 Participants • 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
Glycemic Control Study · Never smoked
|
581 Participants
n=1429 Participants • 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.
|
607 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1188 Participants
n=2856 Participants • 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
Glycemic Control Study · Former Smoker
|
657 Participants
n=1429 Participants • 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.
|
623 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1280 Participants
n=2856 Participants • 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
Glycemic Control Study · Current Smoker
|
191 Participants
n=1429 Participants • 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.
|
196 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
387 Participants
n=2856 Participants • 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
Glycemic Control Study · Missing
|
0 Participants
n=1429 Participants • 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 Participants
n=1427 Participants • 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 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Never smoked
|
—
|
—
|
279 Participants
n=647 Participants • 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.
|
263 Participants
n=616 Participants • 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.
|
313 Participants
n=806 Participants • 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.
|
333 Participants
n=787 Participants • 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.
|
1188 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Former Smoker
|
—
|
—
|
279 Participants
n=647 Participants • 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.
|
276 Participants
n=616 Participants • 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.
|
373 Participants
n=806 Participants • 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.
|
352 Participants
n=787 Participants • 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.
|
1280 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Current Smoker
|
—
|
—
|
89 Participants
n=647 Participants • 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.
|
77 Participants
n=616 Participants • 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.
|
119 Participants
n=806 Participants • 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.
|
102 Participants
n=787 Participants • 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.
|
387 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Missing
|
—
|
—
|
0 Participants
n=647 Participants • 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.
|
0 Participants
n=616 Participants • 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 Participants
n=806 Participants • 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.
|
0 Participants
n=787 Participants • 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 Participants
n=2856 Participants • 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
Glycemic Control Study · None
|
729 Participants
n=1429 Participants • 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.
|
721 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
1450 Participants
n=2856 Participants • 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
Glycemic Control Study · Mild
|
241 Participants
n=1429 Participants • 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.
|
277 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
518 Participants
n=2856 Participants • 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
Glycemic Control Study · Moderate Nonproliferative Diabetic Retinopathy
|
443 Participants
n=1429 Participants • 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.
|
404 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
847 Participants
n=2856 Participants • 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
Glycemic Control Study · Severe Nonproliferative Diabetic Retinopathy
|
5 Participants
n=1429 Participants • 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.
|
5 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
10 Participants
n=2856 Participants • 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
Glycemic Control Study · Proliferative diabetic retinopathy
|
10 Participants
n=1429 Participants • 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.
|
19 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
29 Participants
n=2856 Participants • 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
Glycemic Control Study · Missing
|
1 Participants
n=1429 Participants • 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 Participants
n=1427 Participants • 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.
|
—
|
—
|
—
|
—
|
2 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · None
|
—
|
—
|
328 Participants
n=647 Participants • 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.
|
295 Participants
n=616 Participants • 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.
|
429 Participants
n=806 Participants • 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.
|
398 Participants
n=787 Participants • 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.
|
1450 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Mild
|
—
|
—
|
105 Participants
n=647 Participants • 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.
|
117 Participants
n=616 Participants • 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.
|
141 Participants
n=806 Participants • 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.
|
155 Participants
n=787 Participants • 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.
|
518 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Moderate Nonproliferative Diabetic Retinopathy
|
—
|
—
|
195 Participants
n=647 Participants • 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.
|
198 Participants
n=616 Participants • 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.
|
230 Participants
n=806 Participants • 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.
|
224 Participants
n=787 Participants • 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.
|
847 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Severe Nonproliferative Diabetic Retinopathy
|
—
|
—
|
3 Participants
n=647 Participants • 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 Participants
n=616 Participants • 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.
|
2 Participants
n=806 Participants • 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.
|
4 Participants
n=787 Participants • 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.
|
10 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Proliferative diabetic retinopathy
|
—
|
—
|
14 Participants
n=647 Participants • 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.
|
5 Participants
n=616 Participants • 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.
|
4 Participants
n=806 Participants • 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.
|
6 Participants
n=787 Participants • 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.
|
29 Participants
n=2856 Participants • 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
Blood Pressure and Lipid Studies · Missing
|
—
|
—
|
2 Participants
n=647 Participants • 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.
|
0 Participants
n=616 Participants • 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.
|
0 Participants
n=806 Participants • 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.
|
0 Participants
n=787 Participants • 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.
|
2 Participants
n=2856 Participants • 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.
|
PRIMARY outcome
Timeframe: Measured at Year 4Population: The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses.
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.
Outcome measures
| Measure |
Intensive Glycemia Control
n=1429 Participants
Strategy of intensive glycemia treatment to HbA1c less than 6%
|
Standard Glycemia Control
n=1427 Participants
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
|
Intensive Blood Pressure Control
n=647 Participants
A strategy of BP treatment for SBP less than 120 mmHg
|
Standard Blood Pressure Control
n=616 Participants
Strategy of BP treatment for SBP less than 140 mmHg
|
Fenofibrate + Simvastatin Therapy
n=806 Participants
Blinded fenofibrate + simvastatin 20-40 mg/d
|
Placebo + Simvastatin Therapy
n=787 Participants
Blinded placebo + simvastatin 20-40 mg/d
|
|---|---|---|---|---|---|---|
|
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
|
104 participants
|
149 participants
|
67 participants
|
54 participants
|
52 participants
|
80 participants
|
SECONDARY outcome
Timeframe: Measured at Year 4Population: Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity.
Outcome measures
| Measure |
Intensive Glycemia Control
n=3466 Participants
Strategy of intensive glycemia treatment to HbA1c less than 6%
|
Standard Glycemia Control
n=3511 Participants
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
|
Intensive Blood Pressure Control
n=1629 Participants
A strategy of BP treatment for SBP less than 120 mmHg
|
Standard Blood Pressure Control
n=1617 Participants
Strategy of BP treatment for SBP less than 140 mmHg
|
Fenofibrate + Simvastatin Therapy
n=1883 Participants
Blinded fenofibrate + simvastatin 20-40 mg/d
|
Placebo + Simvastatin Therapy
n=1848 Participants
Blinded placebo + simvastatin 20-40 mg/d
|
|---|---|---|---|---|---|---|
|
Loss of Visual Acuity
|
744 Participants
|
752 Participants
|
367 Participants
|
382 Participants
|
354 Participants
|
393 Participants
|
SECONDARY outcome
Timeframe: Measured at Year 4Population: Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction.
Outcome measures
| Measure |
Intensive Glycemia Control
n=4361 Participants
Strategy of intensive glycemia treatment to HbA1c less than 6%
|
Standard Glycemia Control
n=4405 Participants
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
|
Intensive Blood Pressure Control
n=2053 Participants
A strategy of BP treatment for SBP less than 120 mmHg
|
Standard Blood Pressure Control
n=2039 Participants
Strategy of BP treatment for SBP less than 140 mmHg
|
Fenofibrate + Simvastatin Therapy
n=2333 Participants
Blinded fenofibrate + simvastatin 20-40 mg/d
|
Placebo + Simvastatin Therapy
n=2341 Participants
Blinded placebo + simvastatin 20-40 mg/d
|
|---|---|---|---|---|---|---|
|
Cataract Extraction
|
547 Participants
|
623 Participants
|
266 Participants
|
300 Participants
|
305 Participants
|
299 Participants
|
SECONDARY outcome
Timeframe: Measured at Year 4Outcome measures
| Measure |
Intensive Glycemia Control
n=1413 Participants
Strategy of intensive glycemia treatment to HbA1c less than 6%
|
Standard Glycemia Control
n=1399 Participants
Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
|
Intensive Blood Pressure Control
n=633 Participants
A strategy of BP treatment for SBP less than 120 mmHg
|
Standard Blood Pressure Control
n=609 Participants
Strategy of BP treatment for SBP less than 140 mmHg
|
Fenofibrate + Simvastatin Therapy
n=791 Participants
Blinded fenofibrate + simvastatin 20-40 mg/d
|
Placebo + Simvastatin Therapy
n=779 Participants
Blinded placebo + simvastatin 20-40 mg/d
|
|---|---|---|---|---|---|---|
|
Development or Progression of Macular Edema
|
44 Participants
|
40 Participants
|
18 Participants
|
20 Participants
|
24 Participants
|
22 Participants
|
Adverse Events
Intensive Glycemia Control
Standard Glycemia Control
Intensive BP Control
Standard BP Control
Fibrate
Fibrate Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Walter Ambrosius, PhD
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place