Table 1.

Baseline demographics of the Intention-to-Treat and Per Protocol populations.

		Placebo	LU	B420	LU + B420	Total
Intention-to-Treat	n	56	53	48	52	209
Gender	n, Male/Female	12/44	12/41	9/39	9/43	42/167
Ethnicity	n, Caucasian/Other	55/1	52/1	48/0	51/1	206/3
Age, years	mean ± SD	49.9 ± 8.5	48.8 ± 10.5	50.6 ± 10.6	47.0 ± 11.1	49.1 ± 10.2
Weight, kg	mean ± SD	88.5 ± 12.2	89.4 ± 9.1	88.7 ± 9.3	87.8 ± 11.0	88.6 ± 10.4
BMI, kg/m2	mean ± SD	31.2 ± 2.2	31.2 ± 1.6	31.5 ± 2.2	31.3 ± 2.0	31.3 ± 2.0
Waist circumference, cm	mean ± SD	103.0 ± 8.4	103.4 ± 6.1	102.6 ± 6.9	102.5 ± 6.9	102.9 ± 7.1
Blood glucose, mmol/l	mean ± SD	5.24 ± 0.50	5.20 ± 0.62	5.18 ± 0.43	5.19 ± 0.42	5.20 ± 0.50
Total Cholesterol, mmol/l	mean ± SD	5.23 ± 0.87	5.22 ± 1.00	5.26 ± 1.08	5.50 ± 0.96	5.30 ± 0.97
LDL Cholesterol, mmol/l	mean ± SD	3.10 ± 0.77	3.08 ± 0.82	3.25 ± 0.91	3.38 ± 0.89	3.20 ± 0.85
Triglycerides, mmol/l	mean ± SD	1.22 ± 0.61	1.27 ± 0.53	1.27 ± 0.56	1.29 ± 0.61	1.26 ± 0.58
Per-Protocol	n	36	36	25	37	134
Gender	n, Male/Female	10/26	8/28	7/18	6/31	31/103
Ethnicity	n, Caucasian/Other	36/0	35/1	25/0	37/0	133/1
Age, years	mean ± SD	48.3 ± 8.6	48.6 ± 10.9	49.1 ± 11.9	47.1 ± 10.9	48.2 ± 10.4
Weight, kg	mean ± SD	88.7 ± 12.5	89.7 ± 9.4	88.9 ± 10.3	87.7 ± 11.3	88.7 ± 10.9
BMI, kg/m2	mean ± SD	31.0 ± 2.2	31.2 ± 1.6	30.9 ± 1.9	31.2 ± 2.0	31.1 ± 1.9
Waist circumference, cm	mean ± SD	102.1 ± 7.5	103.3 ± 6.6	103.3 ± 7.5	102.1 ± 7.3	102.7 ± 7.2
Blood glucose, mmol/l	mean ± SD	5.21 ± 0.54	5.18 ± 0.68	5.16 ± 0.35	5.22 ± 0.42	5.20 ± 0.52
Total Cholesterol, mmol/l	mean ± SD	5.16 ± 0.86	5.24 ± 1.01	5.14 ± 0.86	5.58 ± 0.90	5.29 ± 0.92
LDL Cholesterol, mmol/l	mean ± SD	3.05 ± 0.75	3.12 ± 0.73	3.12 ± 0.66	3.39 ± 0.84	3.17 ± 0.76
Triglycerides, mmol/l	mean ± SD	1.20 ± 0.67	1.25 ± 0.54	1.33 ± 0.58	1.36 ± 0.66	1.28 ± 0.62