Efficacy and safety of vildagliptin/pioglitazone combination therapy in Korean patients with diabetes

Table 1 Baseline demographics and background characteristics of Korean patients (randomized population)

Mean±SD	Vilda/Pio 100/30 mg q.d.	Vilda/Pio 50/15 mg q.d.	Vilda 100 mg q.d.	Pio 30 mg q.d.
N	34	34	36	36
Males, n (%)	23 (67.6)	25 (73.5)	32 (88.9)	30 (83.3)
Age (years)	52.9 ± 10.6	51.3 ± 10.3	49.8 ± 10.0	49.2 ± 9.4
BMI (kg/m2)	24.7 ± 2.8	24.7 ± 2.5	24.7 ± 2.2	24.3 ± 2.3
HbA1c (%)	8.4 ± 0.8	8.8 ± 0.9	8.6 ± 0.9	8.7 ± 0.9
FPG (mmol/L)	9.4 ± 2.0	10.1 ± 2.0	10.9 ± 2.6	9.8 ± 2.6
Duration of T2DM (years)	3.1 ± 3.6	1.6 ± 2.4	1.9 ± 2.5	2.1 ± 2.7

T2DM: type 2 diabetes mellitus; FPG: fasting plasma glucose; HbA_1c: hemoglobin A_1c; BMI: body mass index.

Table 2 Number (%) of Korean patients with adverse events, SAEs, and discontinuations (safety population)

	Vilda/Pio 100/30 mg q.d. (N = 34) n (%)	Vilda/Pio 50/15 mg q.d. (N = 34) n (%)	Vilda 100 mg q.d. (N = 35) n (%)	Pio 30 mg q.d. (N = 36) n (%)
Any primary system organ class AE	13 (38.2)	15 (44.1)	13 (37.1)	13 (36.1)
Common AEs
Nasopharyngitis	0	4 (11.8)	2 (5.7)	3 (8.3)
Dizziness	2 (5.9)	1 (2.9)	2 (5.7)	3 (8.3)
Headache	3 (8.8)	1 (2.9)	0	0
Upper respiratory tract infection	0	0	2 (5.7)	2 (5.6)
Asthenia	1 (2.9)	1 (2.9)	0	2 (5.6)
Constipation	0	0	2 (5.7)	1 (2.8)
AEs leading to discontinuations	2 (5.9)	2 (5.9)	1 (2.9)	1 (2.8)
Headache	1 (2.9)	0	0	0
Hepatitis	1 (2.9)	0	0	0
Cerebral hemorrhage	0	1 (2.9)	0	0
Colon cancer	0	1 (2.9)	1 (2.9)	0
Generalized edema	0	0	0	1 (2.8)
SAEs	1 (2.9)	2 (5.9)	1 (2.9)	0
Thermal burn	1 (2.9)	0	0	0
Cerebral hemorrhage	0	1 (2.9)	0	0
Colon cancer	0	1 (2.9)	1 (2.9)	0

AEs: adverse events.