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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3472 participants

Primary outcome timeframe

Measured at Year 4

Results posted on

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

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

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

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 4

Population: 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

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 4

Population: Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity.

Outcome measures

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 4

Population: Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction.

Outcome measures

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 4

Outcome measures

Outcome 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Glycemia Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intensive BP Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard BP Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fibrate

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Fibrate Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 336-716-6281

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place