- Baseline to 12 months post-baseline ±6 weeks The primary outcome will be analysed using logistic regression adjusted for the stratification factors (site, entry therapy ((1) monotherapy (2) dual therapy metformin plus pioglitazone (3) dual therapy metformin plus either a sulphonylurea or repaglinide)). The dependent variable will be defined as those achieving all of the composite end point targets. The same analysis method will be used for the secondary composite outcomes.