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Table 3 Hierarchical statistical methods

From: Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control

  Analysis Testing hierarchy for 52-week analysis (interim analysis) Testing hierarchy for 104-week analysis (main analysis)
1 Primary Non-inferiority in change from baseline in HbA1c Non-inferiority in change from baseline in HbA1c
2 Secondary Superiority in change from baseline in body weight Superiority in change from baseline in body weight
3   Superiority in incidence of confirmed hypoglycemic AEs Superiority in incidence of confirmed hypoglycemic AEs
4   Superiority in change from baseline in SBP Superiority in change from baseline in HbA1c
5   Superiority in change from baseline in DBP Superiority in change from baseline in SBP
6    Superiority in change from baseline in DBP
  1. Legend: HbA 1c glycosylated hemoglobin, AEs adverse events, SBP systolic blood pressure, DBP diastolic blood pressure.