An investigator-initiated, double-blind, randomised, placebo-controlled, multicentre phase 2 clinical trial started recruitment in December 2017, with the aim of evaluating the efficacy and safety of GKT13783, in adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48 weeks.<h4>Methods/design</h4>The trial is currently recruiting in Australia and New Zealand, with recruitment expected to end on 30 June 2020. This evidence concerns the gene ALB and diabetes mellitus.