Table 1.

Summary of study designs and patient populations

Study characteristics				Eligibility criteria				mITT population (FS-MMTT subset), n
Study	Treatment	Comparator	Durationa	Agec	HbA1c d	FPGe	eGFRf	PBO	CANA 100	CANA 300	SITA 100
1	Monotherapy [16]	PBO	26b	18–80	7.0–10.0 (53–86)	<15.0 (270)	≥50	192 (76)	195 (79)	197 (80)	NA
2	Add-on to MET + SU [18]	PBO	26b	18–80	7.0–10.5 (53–91)	<15.0 (270)	≥55g	156 (55)	157 (57)	156 (56)	NA
3	Add-on to MET + SU [15]	SITA	52	≥18	7.0–10.5 (53–91)	<16.7 (300)	≥55g	NA	NA	377 (125)	378 (124)

^aIn weeks

^bResults from the 26-week core treatment period are reported here; study also included a 26-week extension period

^cIn years

^dIn % (mmol/mol)

^eIn mmol/l (mg/dl)

^fIn ml min⁻¹ (1.73 m²)⁻¹

^geGFR ≥60 ml min⁻¹ (1.73 m²)⁻¹ if required, based on the local MET label

CANA 100, canagliflozin 100 mg; CANA 300, canagliflozin 300 mg; eGFR, estimated GFR; MET, metformin; NA, not applicable; PBO, placebo; SITA 100, sitagliptin 100 mg; SU, sulfonylurea