Statistical considerations An incident rate of 2.5% per year of macro- and microvascular complications, of 1.5% for cancer and approximate 1% of over-all mortality is expected. Hypoglycaemic event rate is expected to be less than 0.4%. The expected incident rate of the composite endpoint is 5%, a power of 80% and a type I error of 0.05. A benefit of 20% with intervention is expected. Loss to follow-up: the database approach will limit this to a minimum. For a cumulated event rate of 5% during 10 years the estimated sample size is 1123 patients per group.