|
|
Placebo
(N=31) |
5 mg CCX140-B (N=63) |
10 mg CCX140-B (N=31) |
30 mg Pioglitazone (N=31) |
Total adiponectin (mg/mL) |
Baseline |
6.4 (0.66) |
6.1 (0.43) |
6.3 (0.49) |
6.1 (0.65) |
|
Change to Day 29 |
-0.5 (0.54) |
0.1 (0.38) |
0.2 (0.54) |
6.3 (0.55) |
|
Difference from Placebo |
|
0.6 (-0.9, 2.2) |
0.8 (-1.0, 2.6) |
6.9 (5.1, 8.7)c |
Plasma MCP-1 (pg/mL) |
Baseline |
445 (23.3) |
431 (17.7) |
384 (14.3) |
421 (14.8) |
|
Change to Day 29 |
11 (12.2) |
21 (8.6) |
26 (12.5) |
-27 (12.4) |
|
Difference from Placebo |
|
9 (-26, 44) |
14 (-27, 56) |
-39 (-80, 3) |
CRP (mg/L) |
Baseline |
4.3 (1.08) |
6.3 (1.49) |
3.2 (0.53) |
7.1 (1.76) |
|
Change to Day 29 |
-1.2 (0.98) |
-1.2 (0.69) |
-1.5 (1.00) |
-1.2 (1.00) |
|
Difference from Placebo |
|
0.0 (-2.9, 2.8) |
-0.3 (-3.6, 3.0) |
0.0 (-3.3, 3.3)d |
Total Cholesterol (mg/dL) |
Baseline |
180.4 (6.91) |
180.4 (4.86) |
184.2 (5.53) |
182.3 (6.55) |
|
% Change to Day 29 |
0.7% (2.64) |
0.1% (1.87) |
-1.9% (2.64) |
0.3% (2.64) |
|
% Difference from Placebo |
|
-0.6% (-8.3, 7.0) |
-2.6% (-11.4, 6.3) |
-0.4% (-9.2, 8.4) |
HDL cholesterol (mg/dL) |
Baseline |
44.7 (2.35) |
45.6 (1.60) |
43.8 (2.15) |
44.1 (1.68) |
|
% Change to Day 29 |
5.2% (2.33) |
0.1% (1.65) |
3.2% (2.46) |
13.1% (2.33) |
|
% Difference from Placebo |
|
-5.1% (-11.9, 1.6) |
-1.9% (-9.9, 6.1) |
7.9% (0.1, 15.7)e |
LDL cholesterol (mg/dL) |
Baseline |
99.7 (5.96) |
101.9 (5.06) |
98.0 (5.38) |
107.4 (5.86) |
|
% Change to Day 29 |
2.1% (3.49) |
-0.4% (2.51) |
1.1% (3.77) |
-0.4% (3.50) |
|
% Difference from Placebo |
|
-2.5% (-12.7, 7.7) |
-1.0% (-13.2, 11.1) |
-2.5% (-14.2, 9.2) |
Triglycerides (mg/dL) |
Baseline |
194.9 (16.35) |
185.4 (14.48) |
205.5 (15.66) |
157.6 (14.64) |
|
% Change to Day 29 |
-0.2% (6.61) |
10.6% (4.67) |
-0.8% (6.86) |
-9.3% (6.66) |
|
% Difference from Placebo |
|
10.8% (-8.3, 29.9) |
-0.6% (-23.1, 21.9) |
-9.1% (-31.4, 13.1) |
NEFAs (mmol/L) |
Baseline |
0.67 (0.044) |
0.67 (0.034) |
0.64 (0.048) |
0.58 (0.040) |
|
% Change to Day 29 |
-1.7% (5.81) |
1.4% (4.14) |
9.0% (6.11) |
-17.5% (6.04) |
|
% Difference from Placebo |
|
3.1% (-13.8, 20.0) |
10.7% (-9.3, 30.7) |
-15.9% (-35.8, 4.1) |
Monocyte count (x103/mL) |
Baseline |
0.45 (0.146) |
0.46 (0.172) |
0.49 (0.167) |
0.46 (0.164) |
|
Day 29 |
0.42 (0.171) |
0.45 (0.155) |
0.47 (0.183) |
0.44 (0.143) |
Hematocrit (%) |
Baseline |
42.5 (3.58) |
42.5 (3.37) |
42.3 (3.00) |
42.0 (3.26) |
|
Day 29 |
42.5 (3.51) |
41.9 (2.89) |
42.1 (2.73) |
41.2 (2.58) |
Body Weight (kg) |
Baseline |
93.3 (15.6) |
94.1 (17.0) |
95.1 (19.7) |
91.8 (15.9) |
|
Day 29 |
93.2 (15.6) |
93.7 (17.3) |
94.8 (20.0) |
91.6 (16.0) |
amean (SEM); bleast-squares difference compared to placebo, mean (95% confidence interval); cp<0.0001 (Wilcoxon Rank Sum test); dp<0.001 (Wilcoxon Rank Sum
test); ep<0.01 (Wilcoxon Rank Sum test); If Kolmogorov-Smirnov test for normality of residuals was ≤ 0.010, non-parametric testing results are reported, as pre-specified.
LS changes shown are actual changes except for lipids which are shown as percentage change from baseline, as pre-specified. |