ADVANCE (intensive glucose control)
Trial question
What is the role of intensive glucose control in patients with T2DM?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 11140
11140 patients (4733 female, 6407 male)
Inclusion criteria: patients with T2DM
Key exclusion criteria: a definite indication for, or contraindication to, any of the study treatments or a definite indication for long-term insulin therapy at the time of study entry
Interventions
N=5571 intensive glucose control (using gliclazide, modified release 30-120 mg daily, and other drugs, targeting glycated hemoglobin value ≤ 6.5%)
N=5569 standard glucose control (target glycated hemoglobin levels defined on the basis of local guidelines)
Primary outcome
Macrovascular and microvascular events
18.1
20
20.0 %
15.0 %
10.0 %
5.0 %
0.0 %
Intensive glucose control
Standard glucose control
Significant decrease ▼
NNT = 52
Significant decrease in macrovascular and microvascular events (18.1% vs. 20%; HR 0.9, 95% CI 0.82 to 0.98)
Secondary outcomes
Significant decrease in major microvascular events (9.4% vs. 10.9%; HR 0.86, 95% CI 0.77 to 0.97)
Significant decrease in nephropathy (4.1% vs. 5.2%; HR 0.79, 95% CI 0.66 to 0.93)
No significant difference in death from any cause (8.9% vs. 9.6%; HR 0.93, 95% CI 0.83 to 1.06)
Safety outcomes
No significant difference in RRT or death from renal causes.
Significant difference in severe hypoglycemia (2.7% vs. 1.5%).
Conclusion
In patients with T2DM, intensive glucose control was superior to standard glucose control with respect to macrovascular and microvascular events.
Reference
ADVANCE Collaborative Group, Patel A, MacMahon S et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72.
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