VADT
Trial question
What is the role of intensive glucose control in patients with poorly controlled T2DM?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
3.0% female
97.0% male
N = 1791
1791 patients (52 female, 1739 male).
Inclusion criteria: military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for T2DM.
Key exclusion criteria: glycated hemoglobin level < 7.5%, occurrence of a cardiovascular event during the previous 6 months, advanced congestive HF, severe angina, a life expectancy < 7 years, or body-mass index > 40.
Interventions
N=892 intensive therapy (target to achieve a glycated hemoglobin level of < 6%).
N=899 standard therapy (target to achieve a glycated hemoglobin level of < 9%).
Primary outcome
CV events
235
264
264.0
198.0
132.0
66.0
0.0
Intensive
therapy
Standard
therapy
No significant
difference ↔
No significant difference in CV events (235 vs. 264; HR 0.88, 95% CI 0.74 to 1.05).
Secondary outcomes
No significant difference in death from any cause (102 vs. 95; HR 1.07, 95% CI 0.81 to 1.42).
Safety outcomes
Significant differences in serious adverse events (24.1% vs. 17.6%, p = 0.05), including dyspnea (p = 0.006).
Conclusion
In military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for T2DM, intensive therapy was not superior to standard therapy with respect to CV events.
Reference
Duckworth W, Abraira C, Moritz T et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan 8;360(2):129-39.
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