Effect of vildagliptin as add-on therapy to a low-dose metformin

Table 1 Demographic and baseline characteristics (randomized population)

Demographic variable	Vilda 100 mg qd/metformin 500 mg bid N = 456	Metformin up to 1000 mg bid N = 458	Total N = 914
Gender; female, n (%)	226 (49.6)	252 (55)	478 (52.3)
Age; mean ± SD (years)	56.9 ± 9.76	57.0 ± 10.02	57.0 ± 9.89
Age group (≥ 65 years), n (%)	106 (23.2%)	114 (24.9%)	220 (24.1%)
Race
Caucasian	242 (53.1%)	237 (51.7%)	479 (52.4%)
Asian (non-indian subcontinent)	44 (9.6%)	44 (9.6%)	88 (9.6%)
Hispanic or latino	147 (32.2%)	145 (31.7%)	292 (31.9%)
Black	9 (2.0%)	12 (2.6%)	21 (2.3%)
Asian (indian subcontinent)	3 (0.7%)	5 (1.1%)	8 (0.9%)
Native american	1 (0.2%)	2 (0.4%)	3 (0.3%)
Other	10 (2.2%)	13 (2.8%)	23 (2.5%)
Body weight; mean ± SD (kg)	84.6 ± 17.01	84.4 ± 18.94	84.5 ± 17.99
BMI (kg/m2); mean ± SD	31.1 ± 5.11	31.2 ± 5.47	31.1 ± 5.29
HbA1c (%); mean ± SD	7.4 ± 0.78	7.3 ± 0.79a	7.3 ± 0.79
FPG (mmol/L); mean ± SD	8.7 ± 2.28	8.5 ± 2.25	8.6 ± 2.27
Duration of type 2 diabetes; mean ± SD (years)	4.6 ± 4.91	4.7 ± 4.94	4.7 ± 4.92

Demographic information is collected on the day of the screening measurement (Week-4, Visit 1).

^aHemoglobin A_1c (HbA_1c) measurements at Visit 1 not available for one patient (n = 457). FPG: Fasting plasma glucose; BMI: Body mass index.

Table 2 Number (%) of patients reporting common AEs (≥ 2% in any group) and biochemistry abnormalities (safety population)

Preferred term	Vilda 100 mg qd/metformin 500 mg bid N = 456 n (%)	Metformin up to 1000 mg bid N = 458 n (%)
Any preferred term	220 (48.2)	237 (51.7)
Diarrhea	21 (4.6)	39 (8.5)
Headache	18 (3.9)	28 (6.1)
Nasopharyngitis	15 (3.3)	13 (2.8)
Back pain	14 (3.1)	18 (3.9)
Dizziness	14 (3.1)	16 (3.5)
Flatulence	13 (2.9)	8 (1.7)
Upper respiratory tract infection	13 (2.9)	10 (2.2)
Arthralgia	11 (2.4)	6 (1.3)
Hypertension	11 (2.4)	12 (2.6)
Nausea	11 (2.4)	22 (4.8)
Pharyngitis	10 (2.2)	12 (2.6)
Pain in extremity	8 (1.8)	10 (2.2)
Urinary tract infection	8 (1.8)	24 (5.2)
Dyspepsia	7 (1.5)	11 (2.4)
Influenza	7 (1.5)	11 (2.4)
Abdominal pain	5 (1.1)	12 (2.6)
Laboratory evaluation
Any notable abnormalitya	14 (3.2)	14 (3.2)
Alkaline phosphatase ≥ 3 × ULN	0 (0.0)	0 (0.0)
ALT (Alanine aminotransferase) ≥ 3 × ULN	1 (0.2)	1 (0.2)
AST (aspartate aminotransferase) ≥ 3 × ULN	1 (0.2)	2 (0.5)
Bilirubin (direct/conjugated) ≥ 3 × ULN	0 (0.0)	0 (0.0)
Blood Urea Nitrogen (BUN) ≥ 9.99 mmol/L	9 (2.0)	6 (1.4)b
Creatine phosphokinase (CPK) ≥ 5 × ULN	1 (0.2)	0 (0.0)b
Creatinine ≥ 176.8 μmol/L	0 (0.0)	0 (0.0)b
Potassium ≤ 3.0 or ≥ 6.0 mmol/Ll	3 (0.7)c	5 (1.1)b
Sodium ≤ 125 or ≥ 160 mmol/L	1 (0.2)	0 (0.0)b

^aNo. of patients with evaluable criterion in both categories is 441.

^bNo. of patients with evaluable criterion is 437.

^cNo. of patients with evaluable criterion is 440. AEs: Adverse events; ULN: Upper limits of normal.