Table 2.

Empagliflozin monotherapy studies: key safety data

Study	Study details	Regimen details	N	Treatment and dose (mg/d)	Safety parameters (number and percentage of patients with a special interest adverse event)
					Hypoglycemia, n (%)	Urinary tract infection, n (%) [males and females, n (%) if stated]	Genital infection, n (%) [males and females, n (%) if stated]	Volume depletion, n (%)
Roden et al15	Phase III, 24 wk	Monotherapy	228	Pbo	1 (<1)	12 (5) [M3/124 (2), F9/105 (9)]	0 [M0/124, F0/105]	Not reported
			224	EMPA 10	1 (<1)	15 (7) [M3/142 (2), F12/82 (15)]	7 (3) [M4/142 (3), F3/82 (4)]	Not reported
			224	EMPA 25	1 (<1)	12 (5) [M2/144 (1), F10/79 (13)]	9 (4) [M2/144 (1), F7/79 (9)]	Not reported
			223	SITA 100	1 (<1)	11 (5) [M4/141 (3), F7/82 (9)]	2 (1) [M1/141 (1), F1/82 (1)]	Not reported
			87	EMPA 25 (HbA1c >10.0%)	0	3 (3) [M2/64 (3), F1/23 (4)]	1 (1) [M1/64 (2), F0/23]	Not reported
Ferrannini et al16	Phase II, 12 wk	Monotherapy	82	Pbo	1 (1.2)	1 (1.2)	0	Not reported
			81	EMPA 5	0	2 (2.5)	0	Not reported
			81	EMPA 10	0	1 (1.2)	3 (3.7)	Not reported
			82	EMPA 25	0	1 (1.2)	2 (2.4)	Not reported
			80	MET (O/L)	1 (1.2)	2 (2.5)	0	Not reported
Kadowaki et al17	Phase II, 12 wk	Monotherapy	109	Pbo	0	1 (0.9) [M1/80 (1.3), F0/29]	0 [M0/80, F0/29]	1 (0.9)
			110	EMPA 5	0	0 [M0/84, F0/26]	1 (0.9) [M1/84 (1.2), F0/26]	0
			109	EMPA 10	0	1 (0.9) [M1/77 (1.3), F0/32]	1 (0.9) [M1/77 (1.3), F0/32]	1 (0.9)
			109	EMPA 25	1 (0.9)	1 (0.9) [M0/84, F1/25 (4.0)]	0 [M0/84, F0/25]	1 (0.9)
			110	EMPA 50	1 (0.9)	1 (0.9) [M0/85, F1/25 (4.0)]	1 (0.9) [M1/85 (1.2), F0/25]	0

Note: Number of male and female patients in the safety set was not available for all studies; in those cases only percentages are shown. MET dosing: 1000 mg/d for 4 weeks, thereafter increased to 1000 mg twice daily, or up to maximum tolerated dose, if needed.

Abbreviations: EMPA, empagliflozin; F, female; HbA_1c, glycated hemoglobin; M, male; MET, metformin; O/L, open label; Pbo, placebo.