ACCORD | ADVANCE | VADT | |
Participant characteristics | |||
n | 10,251 | 11,140 | 1791 |
Mean age (years) | 62 | 66 | 60 |
Duration of diabetes (years) | 10 | 8 | 11.5 |
History of CVD (%) | 35 | 32 | 40 |
Median baseline A1C (%) | 8.1 | 7.2 | 9.4 |
On insulin at baseline (%) | 35 | 1.5 | 52 |
Protocol characteristics | |||
A1C goals (%; I versus S)* | <6.0 versus 7.0-7.9 | ≤6.5 versus "based on local guidelines" | <6.0 (action if >6.5) versus planned separation of 1.5 |
Protocol for glycemic control (I versus S)* | Multiple drugs in both arms | Multiple drugs added to gliclizide versus 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 | |||
Achieved median A1C (%; I versus S) | 6.4 versus 7.5 | 6.3 versus 7.0 | 6.9 versus 8.5 |
On insulin at study end (%) (I versus S)* | 77 versus 55* | 40 versus 24 | 89 versus 74 |
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; %) | |||
| 16.2 | 2.7 | 21.2 |
| 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) |
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