Novel and emerging diabetes mellitus drug therapies for the type 2 diabetes patient

Table 5 Efficacy assessment of INCB13739 in combination with metformin[30]

	Placebo	5 mg	15 mg	50 mg	100 mg	200 mg
Baseline A1c (%)	8.3 ± 1	8.2 ± 1	8.3 ± 1	8.3 ± 1	8.2 ± 1	8.2 ± 1
LS mean change A1c (%) from baseline	0.09 ± 1	-0.21 ± 1be	-0.11 ± 1	-0.09 ± 2	-0.38 ± 1ae	0.47 ± 1dh
A1c > 8% (n)	-0.10 ± 0.2 (23)	-0.39 ± 0.2e (23)	-0.24 ± 0.2 (18)	-0.65 ± 0.3be (11)	-0.72 ± 0.2ae (16)	0.65 ± 0.2 (19)
A1c (%) for BMI > 30 mg/m2 (n)	0.17 ± 0.1 (29)	-0.24 ± 0.2bf (23)	-0.10 ± 0.2 (26)	-0.25 ± 0.2b (18)	-0.36 ± 0.2a (26)	-0.76 ± 0.2dh (18)
Baseline FPG (mg/dL)	179 ± 51	172 ± 41	175 ± 44	178 ± 53	170 ± 64	165 ± 41
LS mean change from baseline (mg/dL)	12.6 ± 6.1	6 ± 6.3	2.3 ± 6.4	-4.7 ± 7.2b	-1.6 ± 6.1b	-11.5 ± 6.2df
Weight (kg)	-0.2 ± 0.3	-0.5 ± 0.38	-0.6 ± 0.4e	0 ± 0.4	-1.1 ± 0.3be	-0.9 ± 0.3h
HOMA-IR	0.25 ± 0.4	-0.29 ± 0.4	0.33 ± 0.4	-0.42 ± 0.5	0.51 ± 0.4	-1.06 ± 0.4ae

Data are placebo adjusted least-squares (LS) mean change from baseline: mean ± SE.

^aP < 0.05,

^bP < 0.01,

^dP < 0.01, active vs Placebo,

^eP < 0.05,

^fP < 0.01,

^hP < 0.01, week 12 vs baseline. A1c: Hemoglobin A1c; FPG: Fasting plasma glucose; LS: Least squares; BMI: Body mass index; HOMA-IR: Homeostatic model assessment-insulin resistance.