Table 1.

Difference versus placebo or comparator in change from baseline in HbA1c, FPG, and PPG with saxagliptin in 24-week phase 3 clinical trials

	Saxagliptin	HbA1c (%)		FPG (mg/dL)		PPG (mg/dL)
		2.5 mg/day	5 mg/day	2.5 mg/day	5 mg/day	2.5 mg/day	5 mg/day
SAXA vs PBO, treatment-naïve patients
NCT00121641 [19]	Difference vs PBO	−0.62	−0.65	−21	−15	−39	−37
N = 401a	P value	<0.0001	<0.0001	0.0002	0.007	0.0007	0.0009
NCT00316082 [16]	Difference vs PBO	−0.45	−0.40	−15	−14	−30	−31
N = 365a	P value	0.002	0.006	0.020	0.027	0.019	0.019
NCT00698932 [18]	Difference vs PBO	–	−0.50	–	−13	–	−24
N = 568a	P value		<0.0001		<0.0001		NT
NCT00918879 [17]	Difference vs PBO	–	−0.46	–	−10	–	–
N = 213a	P value		0.0011		NS
SAXA vs PBO, add-on to MET
NCT00121667 [21]	Difference vs PBO	−0.73	−0.83	−16	−23	−44	−40
N = 743a	P value	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001
NCT00661362 [23]	Difference vs PBO	–	−0.42	–	−10	–	−18
N = 570a	P value		<0.0001		0.0002		NT
NCT00327015 [24]	Difference vs PBO	–	−0.5	–	−13	–	−41
N = 1306a	P value		<0.0001		0.0002		<0.0001
NCT01006590 [22]	Difference vs PBO	–	−0.10	–	0	–	–
N = 286a	P value		NS		NT
SAXA vs PBO add-on to TZD
NCT00295633 [25]	Difference vs PBO	−0.36	−0.63	−11	−14	−36	−5
N = 565a	P value	0.0007	<0.0001	0.005	0.0005	<0.0001	<0.0001
SAXA vs PBO, add-on to insulin ± MET
NCT00757588 [27]	Difference vs PBO	–	−0.41	–	−4	–	−23
N = 455a	P value		<0.0001		NS		0.0016
SAXA vs PBO, add-on to glyburide
NCT00313313 [26]	Difference vs PBO	−0.62	−0.72	−8	−11	−39	−42
N = 768a	P value	<0.0001	<0.0001	0.02	0.002	<0.0001	<0.0001
SAXA vs PBO, add-on to MET + SU
NCT01128153 [28]	Difference vs PBO	–	−0.66	–	−8	–	−17
N = 257a	P value		0.0001		NS		0.03
SAXA vs glipizide, add-on to MET (noninferiority trial)b
NCT00575588 [29]	Difference vs glipizide	–	0.06	–	6	–	−21
N = 858a	P value		NS		NT		NT

FPG fasting plasma glucose, HbA1c glycated hemoglobin, MET metformin, NS not significant, NT not tested, PBO placebo, PPG postprandial glucose 120 min following a test meal, SAXA saxagliptin, SU sulfonylurea, TZD thiazolidinedione

^aNumber of patients randomized and treated

^bTrial was 52 weeks in duration