Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes

Background The effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain. Methods We randomly assigned 1791 military veterans ( mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive- therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard- therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene. Results The median follow- up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard- therapy group and 6.9% in the intensive- therapy group. The primary outcome occurred in 264 patients in the standard- therapy group and 235 patients in the intensive- therapy group (hazard ratio in the intensive- therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P = 0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause ( hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P = 0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard- therapy group and 24.1% in the intensive- therapy group. Conclusions Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications. (ClinicalTrials. gov number, NCT00032487.).