This study reports the effects of an intensive therapeutic strategy (targeting a glycated haemoglobin level >6.0%) on mortality and major cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors. 10,251 patients with a median glycated haemoglobin level of 8.1% were assigned to receive intensive therapy or standard therapy (targeting a level from 7.0 to 7.9%). Stable median glycated haemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively, at 1 year and were maintained throughout the 3.5-year follow-up period. Compared with standard therapy, the use of intensive therapy was associated with significantly higher rates of hypoglycaemia, weight gain, and fluid retention. The rate of death from any cause was significantly higher in the intensive-therapy group than in the standard-therapy group, and major cardiovascular events were not significantly reduced with intensive therapy.
