|
ACCORD |
ADVANCE |
VADT |
|
| Participant characteristics |
|
|
|
| n |
10,251 |
11,140 |
1,791 |
| Mean age (years) |
62 |
66 |
60 |
| Duration of diabetes (years) |
10 |
8 |
11.5 |
| Sex (% male/female) |
39/61 |
42/58 |
97/3 |
| History of CVD (%) |
35 |
32 |
40 |
| BMI (kg/m2)
|
32 |
28 |
31 |
| Median baseline A1C (%) |
8.1 |
7.2 |
9.4 |
| On insulin at baseline (%) |
35 |
1.5 |
52 |
| Protocol characteristics |
|
|
|
| A1C goals (%) (I vs. S)* |
<6.0 vs. 7.0–7.9 |
 6.5 vs. "based on local guidelines"
|
<6.0 (action if >6.5) vs. planned separation of 1.5 |
| Protocol for glycemic control (I vs. S)* |
Multiple drugs in both arms |
Multiple drugs added to gliclizide vs. multiple drugs with no gliclizide |
Multiple drugs in both arms |
| Management of other risk factors |
Embedded blood pressure and lipid trials |
Embedded blood pressure trial |
Protocol for intensive treatment in both arms |
| On-study characteristics |
|
|
|
| Median duration of follow-up (years) |
3.5 (terminated early) |
5 |
5.6 |
| Achieved median A1C (%) (I vs. S)* |
6.4 vs. 7.5 |
6.3 vs. 7.0 |
6.9 vs. 8.5 |
| On insulin at study end (%) (I vs. S)* |
77 vs. 55* |
40 vs. 24 |
89 vs. 74 |
| On TZD at study end (%) (I vs. S)* |
91 vs. 58* |
17 vs. 11 |
53 vs. 42 |
| On statin at study end (%) (I vs. S)* |
88 vs. 88* |
46 vs. 48 |
85 vs. 83 |
| On aspirin at study end (%) (I vs. S)* |
76 vs. 76* |
57 vs. 55 |
88 vs. 86 |
| Smokers at study end (%) |
10 |
8 |
8 |
| Mean blood pressure at study end (mmHg) |
|
|
|
| Intensive glycemic control arm |
126/67 |
136/74 |
127/68 |
| Standard glycemic control arm |
127/68 |
138/74 |
125/69 |
| Weight changes (kg) |
|
|
|
| Intensive glycemic control arm |
+3.5 |
–0.1 |
+7.8 |
| Standard glycemic control arm |
+0.4 |
–1.0 |
+3.4 |
| Severe hypoglycemia (participants with one or more episodes during study) (%) |
|
|
|
| Intensive glycemic control arm |
16.2 |
2.7 |
21.2 |
| Standard glycemic control arm |
5.1 |
1.5 |
9.9 |
| Outcomes |
|
|
|
| Definition of primary outcome |
Nonfatal MI, nonfatal stroke, CVD death |
Microvascular plus macrovascular (nonfatal MI, nonfatal stroke, CVD death) outcomes |
Nonfatal MI, nonfatal stroke, CVD death, hospitalization for heart failure, revascularization |
| HR for primary outcome (95% CI) |
0.90 (0.78–1.04) |
0.9 (0.82–0.98); macrovascular 0.94 (0.84–1.06) |
0.88 (0.74–1.05) |
| HR for mortality findings (95% CI) |
1.22 (1.01–1.46) |
0.93 (0.83–1.06) |
1.07 (0.81–1.42) |