Table 4.

Micronucleus frequency induced by vildagliptin and sitagliptin in cultured human lymphocytes

Test substance (µg/ml)	Concentration (µg/ml)	Period	S9 mix	BN cells according to MN number					% MN ± SE	Distribution of cells according to nucleus number				NBI ± SE
				0	1	2	3	>3		1	2	3	4
DMSO	1	24 h	–	7970	30	–	–	–	0.38 ± 0.08	731	2916	53	300	1.98 ± 0.07
MMC	0.16	24 h	–	7779	216	5	–	–	2.76 ± 0.44	1917	2077	1	9	1.53 ± 0.13
Vildagliptin	125	24 h	–	7972	25	3	–	–	0.35 ± 0.05	781	2844	60	320	1.98 ± 0.05
Vildagliptin	250	24 h	–	7977	23	–	–	–	0.29 ± 0.06	767	2918	47	266	1.95 ± 0.07
Vildagliptin	500	24 h	–	7980	19	1	–	–	0.25 ± 0.07	1041	2682	71	236	1.89 ± 0.16
DMSO	1	48 h	–	7965	32	2	1	–	0.44 ± 0.13	731	2916	53	300	1.98 ± 0.03
MMC	0.16	48 h	–	6755	1088	143	–	–	15.39 ± 3.00	1917	2077	1	9	1.41 ± 0.06
Vildagliptin	125	48 h	–	7978	22	–	–	–	0.28 ± 0.07	781	2844	60	320	1.91 ± 0.09
Vildagliptin	250	48 h	–	7968	29	–	–	–	0.36 ± 0.07	767	2918	47	266	1.89 ± 0.07
Vildagliptin	500	48 h	–	7983	15	2	–	–	0.21 ± 0.07	1041	2682	71	236	1.99 ± 0.05
DMSO	1	3 h	+	7968	29	3	–	–	0.40 ± 0.11	731	2916	53	300	1.97 ± 0.09
CP	45	3 h	+	7831	161	8	–	–	2.11 ± 0.26	1968	1722	135	175	1.63 ± 0.09
Vildagliptin	125	3 h	+	7967	31	2	–	–	0.41 ± 0.13	781	2844	60	320	1.99 ± 0.05
Vildagliptin	250	3 h	+	7974	23	3	–	–	0.33 ± 0.13	767	2918	47	266	1.98 ± 0.10
Vildagliptin	500	3 h	+	7985	14	1	–	–	0.19 ± 0.09	1041	2682	71	236	1.96 ± 0.05
DMSO	1	24 h	–	7979	20	1	0	0	0.26 ± 0.04	590	3220	59	228	2.03 ± 0.08
MMC	0.16	24 h	–	7735	255	8	1	1	3.31 ± 1.06	1512	2450	8	10	1.62 ± 0.06
Sitagliptin	250	24 h	–	7964	35	1	0	0	0.45 ± 0.24	579	3173	48	200	1.97 ± 0.04
Sitagliptin	500	24 h	–	7969	29	2	0	0	0.39 ± 0.19	812	3035	39	114	1.86 ± 0.08
Sitagliptin	1000	24 h	–	7976	24	0	0	0	0.30 ± 0.07	1289	2664	8	25	1.69 ± 0.08*
DMSO	1	48 h	–	7948	48	4	0	0	0.65 ± 0.34	631	3089	50	230	1.97 ± 0.05
MMC	0.16	48 h	–	6361	1448	163	24	4	20.49 ± 3.83	2130	1798	57	15	1.49 ± 0.08
Sitagliptin	250	48 h	–	7968	31	1	0	0	0.40 ± 0.15	871	3062	17	50	1.81 ± 0.06
Sitagliptin	500	48 h	–	7961	36	3	0	0	0.49 ± 0.20	1536	2446	6	12	1.62 ± 0.10
Sitagliptin	1000	48 h	–	7968	32	0	0	0	0.40 ± 0.09	3259	737	4	0	1.19 ± 0.05*
DMSO	1	3 h	+	7979	20	1	0	0	0.26 ± 0.04	590	3110	59	228	1.97 ± 0.08
CP	45	3 h	+	7831	161	8	–	–	2.11 ± 0.26	1968	1722	135	175	1.63 ± 0.09
Sitagliptin	250	3 h	+	7976	24	0	0	0	0.30 ± 0.12	525	3220	50	202	1.98 ± 0.05
Sitagliptin	500	3 h	+	7981	17	2	0	0	0.24 ± 0.09	577	3132	62	233	1.99 ± 0.05
Sitagliptin	1000	3 h	+	7974	26	0	0	0	0.33 ± 0.06	598	3256	22	119	1.91 ± 0.05

* Significantly different from the solvent control p < 0.05 (ANOVA)