Table 4.

Adverse events, including genital infections and urinary tract infections and hypoglycemia,^* with dapagliflozin in Phase III trials.

				Patients, %
				Dapagliflozin, mg/d
Trial	Duration, weeks	AE	Placebo or control	5	10
Monotherapy (NCT00528372) [47]	24	≥1 AE	60	58	69
		Genital	1	8	13
		Urinary	4	13	6
		Hypoglycemia	3	0	3
Add-on to MET (NCT00528879) [46]	24	≥1 AE	64	69	73
		Genital	5	13	9
		Urinary	8	7	8
		Hypoglycemia	3	4	4
Add-on to glimepiride (NCT00680745) [48]	24	≥1 AE	47	48	50
		Genital	1	6	7
		Urinary	6	7	5
		Hypoglycemia	5	7	8
Add-on to pioglitazone (NCT00683878) [49]	24	≥1 AE	67	68	71
		Genital	3	9	9
		Urinary	8	9	5
		Hypoglycemia	1	2	0
Add-on to sitagliptin ± MET (NCT00984867) [57]	24	≥1 AE	48	ND	53
		Genital	<1	ND	8
		Urinary	4	ND	5
		Hypoglycemia	3	ND	2
Add-on to insulin (NCT00673231) [50]	24	≥1 AE	73	72	74
		Genital	3	10	11
		Urinary	5	11	10
		Hypoglycemia	52	56	54
Add-on to MET vs glipizide add-on to MET (NCT00660907) [40]	52	≥1 AE	78	ND	78
		Genital	3	ND	12
		Urinary	6	ND	11
		Hypoglycemia	41	ND	4
Add-on to MET + SU (NCT01392677) [78]	24	≥1 AE	51	ND	49
		Genital	0	ND	6
		Urinary	6	ND	6
		Hypoglycemia	4	ND	13
Dapagliflozin 5 mg combined with MET XR as initial therapy (NCT00643851) [41]	24	≥1 AE	59	69	ND
		Genital	2	7	ND
		Urinary	8	8	ND
		Hypoglycemia	0	3	ND
Dapagliflozin 10 mg combined with MET XR as initial therapy (NCT00859898) [41]	24	≥1 AE	57	ND	60
		Genital	2	ND	9
		Urinary	4	ND	8
		Hypoglycemia	3	ND	3

^*Hypoglycemia defined as symptoms suggestive of hypoglycemia or asymptomatic/symptomatic with plasma glucose <63 mg/dL.

AE, adverse event; MET, metformin; ND, not determined; SU, sulfonylurea; XR, extended release.