Secondary analyses relating to stratification hypotheses
hypoglycaemia
REGRESSION, SECONDARY, HYPOGLYCAEMIA
Tolerability: We tested whether the odds of each of tolerability, side effects (any versus none), and hypoglycaemia (any versus none) differed by the two hypothesised drug/stratum combinations. Each of these secondary outcomes were binary variables, so analysis followed the same approach as primary analysis using the same predictors but using mixed effects logistic regression models instead. As before, the drug*strata interaction represented the effect size of interest but this time the output was an odds ratio, as the data were binary.Weight: We assessed differences in weight by drug/stratum as in the primary analysis hypotheses using similar mixed effects models to that used in primary analysis but with weight as the outcome.Patient preference: For each hypothesis, we examined whether patient’s preferred drug differed by strata. All other analysis relating to patient preference is reported in an additional paper submitted separately (reference). For each hypothesis, we compared whether the proportions preferring each of the two drugs of interest differed by strata using the chi-squared test.