Five components of the estimand for both study hypotheses
hypoglycaemia
HYPOGLYCAEMIA, SIDE EFFECT, HYPOGLYCAEMIA
Primary analysis hypothesis 1. Absolute unadjusted values for HbA1c on pioglitazone and sitagliptin split by BMI strata and the corresponding mean difference between drugs, and between strata. P value assessed by a t test comparing the difference between drugs between strata.negative values favour pioglitazone.Primary analysis hypothesis 2. Absolute unadjusted values for HbA1c on sitagliptin and canagliflozin split by eGFR strata and the corresponding mean difference between drugs, and between strata. P value assessed by a t test comparing the difference between drugs between strata.negative values favour sitagliptin.Tolerability by Hypothesised Drug/Strata combinations. Proportions tolerating therapy (remaining on therapy for at least 12 weeks) for each of the drug/strata combinationsSide effects by Hypothesised Drug/Strata Combinations. Proportions experiencing at least one side effect for each of the hypothesised drug/strata combinations.Weight difference by drug and strata. P value assessed by a t test comparing the difference between drugs between strata.Hypoglycaemia by hypothesised drug/strata combinations. Proportions experiencing hypoglycaemia for each of the hypothesised drug/strata combinations.