Efficacy and safety of vildagliptin in clinical practice-results of the PROVIL-study

Table 1 Baseline demographic and clinical characteristics

	Vildagliptin add-on to metformin		Vildagliptin + metformin (SPC)		Other OADs
	n	mean ± SD or n (%)	n	mean ± SD or n (%)	n	mean ± SD or n (%)
Sex
Male		338 (56.1)		1247 (56.7)		436 (51.5)
Female		263 (43.6)		938 (42.7)		404 (47.7)
Age (yr)
Total	578	63.0 ± 11.1	2115	62.4 ± 10.6	819	63.2 ± 11.0
Male	324	62.1 ± 10.8	1200	61.4 ± 10.2	422	62.5 ± 11.0
Female	252	64.1 ± 11.5	902	63.7 ± 11.0	392	64.0 ± 11.0
Weight (kg)
Total	601	89.3 ± 16.8	2183	90.6 ± 17.5	836	87.9 ± 16.5
Male	337	93.7 ± 16.3	1239	95.1 ± 17.0	432	92.3 ± 15.6
Female	262	83.7 ± 15.7	931	84.6 ± 16.3	397	83.0 ± 16.0
BMI (kg/m²)
Total	601	30.6 ± 5.3	2181	31.1 ± 5.5	836	30.3 ± 5.2
Male	337	30.4 ± 5.0	1239	30.7 ± 5.1	432	29.8 ± 4.7
Female	262	30.9 ± 5.6	929	31.6 ± 6.0	397	30.8 ± 5.6
Underweight/normal weight (BMI < 25)		70 (11.6)		174 (8.0)		90 (10.8)
Overweight/obese (BMI ≥ 25)		531 (88.4)		2007 (92.0)		746 (89.2)
Mean (Median) duration of type II diabetes mellitus (yr)	556	6.2 ± 5.3 (median: 5.0)	2010	6.2 ± 5.1 (median: 5.0)	588	5.9 ± 5.2 (median: 4.5)
< 1		78 (14.0)		235 (11.7)		93 (15.8)
≥ 1 and < 5		197 (35.4)		771 (38.4)		215 (36.6)
≥ 5		281 (50.5)		1004 (50.0)		280 (47.6)
HbA1c (%)	597	7.8 ± 1.2	2186	7.9 ± 1.3	832	7.6 ± 1.2
< 6.5		43 (7.2)		150 (6.9)		91 (10.9)
≥ 6.5 and < 7.5		222 (37.2)		747 (34.2)		357 (42.9)
≥ 7.5 and < 10		300 (50.3)		1119 (51.2)		353 (42.4)
≥ 10		32 (5.4)		167 (7.6)		31 (3.7)
Fasting plasma glucose (mg/dL)	560	158.6 ± 47.2	2091	160.4 ± 49.0	797	151.3 ± 46.5
Serum creatinine (μmol/L)	552	82.4 ± 21.4	2053	82.2 ± 19.0	769	84.4 ± 22.8

The number of patients (n) given in this table constitutes the number of patients who had data available for the respective parameters and thus differ from the number of patients in the cohorts given in Figure 1. BMI: Body mass index; HbA1c: Glycosylated hemoglobin; OADs: Oral antidiabetic drugs; SPC: Single pill combination.