Cox regression to analyze time to first MACE, CV death, non-CV death or all-cause mortality with either SH at any time (yes/no) as a factors or with hypoglycaemia (SH or confirmed, yes/no) as a time-dependent covariate.Adjustments for randomized treatment, basline covariates, concomitant insulin use, HbA1c during trial, concomitant sufonylurea/glinide use, eGFR and event adjudication committee-confirmed hospitalization for heart failure during the trial (time-dependent covariates). The gene discussed is INS; the disease is Hypoglycemia.