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

Table 3 Hierarchical statistical methods

	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 HbA_1c	Non-inferiority in change from baseline in HbA_1c
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 HbA_1c
5		Superiority in change from baseline in DBP	Superiority in change from baseline in SBP
6			Superiority in change from baseline in DBP

Legend: HbA_1c glycosylated hemoglobin, AEs adverse events, SBP systolic blood pressure, DBP diastolic blood pressure.

ISSN: 1475-2840