The first published trial was a 26 week double-blind, double-dummy RCT including 247 insulin-naive participants with type 2 diabetes inadequately controlled [HbA1c 53–80 mmol/mol (7.0–9.5%)] on metformin with or without a dipeptidyl peptidase-4 inhibitor (DPP4i) [23]. This evidence concerns the gene INS and type 2 diabetes mellitus.