Table 1.

Empagliflozin monotherapy studies: key efficacy data

Study	Study details	Regimen details	N	Treatment and dose	Efficacy parameters (change from baseline)a
					HbA1c (%)	FPG (mg/dL)	FPG (mmol/L)	Body weight (kg)	SBP (mmHg)
Roden et al15	Phase III, 24 wk	Monotherapy	228	Pbo	0.08	11.7	0.65	−0.33	−0.3
			224	EMPA 10	−0.66	−19.5	−1.08	−2.26	−2.9
			224	EMPA 25	−0.78	−24.5	−1.36	−2.48	−3.7
			223	SITA 100	−0.66	−6.8	−0.38	0.18	0.5
			87	EMPA 25 (HbA1c >10.0%)	−3.70	−87.6	−4.86	−2.43	−4.0
Ferrannini et al16	Phase II, 12 wk	Monotherapy	82	Pbo	0.1	0.72	0.04	−0.75	Not reported
			81	EMPA 5	−0.4	−23.24	−1.29	−1.81	Not reported
			81	EMPA 10	−0.5	−29.00	−1.61	−2.33	Not reported
			82	EMPA 25	−0.6	−30.99	−1.72	−2.03	Not reported
			80	MET (O/L)	−0.7	−29.91	−1.66	−1.32	Not reported
Kadowakiet al17	Phase II, 12 wk	Monotherapy	109	Pbo	0.30	4.06	0.23	−0.9	−1.38
			110	EMPA 5	−0.42	−22.65	−1.26	−2.5	−2.85
			109	EMPA 10	−0.40	−25.28	−1.40	−2.6	−5.57
			109	EMPA 25	−0.65	−33.70	−1.87	−2.9	−4.60
			110	EMPA 50	−0.61	−32.54	−1.81	−3.1	−5.21

Notes:

^awhere publications reported FPG in mg/dL, these were converted to mmol/L using a factor of 0.0555, and vice versa. To convert HbA_1c from % to mmol/mol, use the calculator from the NGSP (National Glycohemoglobin Standardization Program) available from http://www.ngsp.org/convert1.asp. 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; FPG, fasting plasma glucose; HbA_1c, glycated hemoglobin; MET, metformin; O/L, open label; Pbo, placebo; SBP, systolic blood pressure.