Background: Data suggests that the benefits of intensive glucose lowering may emerge over time. The primary aim of the ADVANCE-ON post-trial observational study is to define the long-term effects of intensive glucose control with a gliclazide MR-based regimen (targeting an HbA1c ≤6.5%) compared to standard glucose control on death and major macrovascular events in high-risk patients with established type 2 diabetes. Here we report on the characteristics of those patients recruited to date.Methods: The last visits in the ADVANCE trial were completed at the end of January 2008. All 10,063 surviving ADVANCE trial patients who returned to the care of their usual physicians after ceasing the randomised interventions have been invited to participate. A random sample of patients was selected for repeat measurement of HbA1c and BP levels. Results: By mid-May 2012, 8,194 patients (mean age 76 years, 43% female) had completed their first post-trial visit (22% Australasia, 38% China, 4% Canada, 16% Continental Europe and 20% Northern Europe). 622 of these patients had died (mortality rate: 1.82 per 100 person years) and 1,413 had repeat HbA1c and BP measurement. While treatment with glucose lowering drugs has converged, 36% of those in the original intensive glucose control group were still taking insulin compared to 31% in the standard group. At this time, the mean HbA1c levels of the original intensive and standard glucose control groups were 7.25% and 7.30% respectively, and the mean BP level in both the original perindopril indapamide and placebo groups was 137/75mmHg. Conclusion: As expected early after completion of the ADVANCE trial and cessation of the randomised interventions the patterns of glucose and BP control in the treatment groups have converged. Recruitment and data collection is now ongoing to ensure all post-trial patient outcomes are captured.