ACCORD
Trial question
What is the role of intensive glycemic control therapy in high-risk patients with T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 10251
10251 patients (3895 female, 6356 male)
Inclusion criteria: patients with T2DM who had either established CVD or additional cardiovascular risk factors
Key exclusion criteria: frequent or recent serious hypoglycemic events, unwillingness to do home glucose monitoring or inject insulin, a body-mass index > 45, a serum creatinine level > 1.5 mg/dL (133 mcmol/L), or other serious illness
Interventions
N=5128 intensive glycemic control (targeting an HbA1C < 6.0%)
N=5123 standard glycemic control (targeting an HbA1C 7.0-7.9%)
Primary outcome
Nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes
6.9
7.2
7.2 %
5.4 %
3.6 %
1.8 %
0.0 %
Intensive glycemic control
Standard glycemic control
No significant difference ↔
No significant difference in nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes (6.9% vs. 7.2%; HR 0.9, 95% CI 0.78 to 1.04)
Secondary outcomes
Significant increase in the rate of death at a mean follow-up of 3.5 years (5% vs. 4%; HR 1.22, 95% CI 1.01 to 1.46)
Safety outcomes
Significant differences in hypoglycemia requiring assistance (16.2% vs. 5.1%, p < 0.001) and weight gain > 10 kg (27.8% vs. 14.1%, p < 0.001).
Conclusion
In patients with T2DM who had either established CVD or additional cardiovascular risk factors, intensive glycemic control was not superior to standard glycemic control with respect to nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes.
Reference
Action to Control Cardiovascular Risk in Diabetes Study Group, Gerstein HC, Miller ME et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59.
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