Study design
adult-onset autoimmune diabetes
The ADVENT (Adding DPP-4 inhibitor and vitamin D for adult-onset autoimmune diabetes) study is a prospective, multi-centre, open-label, randomized controlled trial, comprising a 6-week run-in period and then 24-month treatment period. The trial was conducted from September 2015 to December 2020 at 36 sites across 18 provinces and 3 province-level municipalities in China in accordance with the principles of the Declaration of Helsinki, and the International Conference on Harmonisation guidelines for Good Clinical Practice. Ethical committee approval was obtained at the Ethics Committee of the Second Xiangya Hospital, Central South University and each participating site. All participants provided signed, written informed consent before trial entry.