Quality of life, patient satisfaction, and cardiovascular outcomes of the randomised 2 x 3 factorial Copenhagen insulin and Metformin therapy (CIMT) trial – A detailed statistical analysis plan

An updated literature search 28th of January 2022 did not identify any additional randomised clinical trials evaluating the effects of adding metformin to insulin in people with type 2 diabetes. Therefore, the CIMT trial is the hitherto largest and longest randomised clinical trial assessing the effects of metformin in addition to insulin in people with type 2 diabetes on quality of life, well-being, and development of cardiovascular complications.