|
|
Placebo
(N=31) |
5 mg CCX140-B (N=63) |
10 mg CCX140-B (N=31) |
30 mg Pioglitazone (N=31) |
FPG (mg/dL) |
Baseline |
183.9 (9.61) |
166.0 (4.38) |
163.3 (6.77) |
169.8 (7.26) |
|
Change to Day 29a |
-10.7 (4.55) |
-4.3 (3.18) |
-16.1 (4.51) |
-21.4 (4.49) |
|
Difference from Placebob |
|
6.4 (-6.7, 19.6) |
-5.3 (-20.5, 9.9) |
-10.7 (-25.8, 4.4) |
HbA1c (%) |
Baseline |
7.58 (0.180) |
7.38 (0.095) |
7.33 (0.157) |
7.54 (0.153) |
|
Change to Day 29 |
-0.09 (0.050) |
-0.09 (0.035) |
-0.23 (0.052) |
-0.13 (0.051) |
|
Difference from Placebo |
|
0.00 (-0.14, 0.15) |
-0.14 (-0.31, 0.03)c |
-0.04 (-0.21, 0.12) |
Fructosamine (mmol/L) |
Baseline |
291.5 (9.27) |
284.1 (4.58) |
286.2 (8.73) |
289.4 (6.69) |
|
Change to Day 29 |
0.7 (4.12) |
-3.8 (2.94) |
-3.6 (4.41) |
-10.6 (4.19) |
|
Difference from Placebo |
|
-4.6 (-16.5, 7.4) |
-4.3 (-18.6, 10.0) |
-11.4 (-25.3, 2.5) |
OGTT Glucose AUC (mg/dL•hr) |
Baseline |
840 (33.5) |
801 (22.7) |
771 (28.5) |
809 (32.9) |
|
Change to Day 29 |
-35 (16.8) |
-18 (12.2) |
-29 (18.4) |
-115 (17.0) |
|
Difference from Placebo |
|
17 (-32, 66) |
6 (-53, 65) |
-80 (-136, -22)d |
OGTT Insulin AUC (mIU/mL•hr) |
Baseline |
142 (31.2) |
126 (12.2) |
130 (16.4) |
135 (36.4) |
|
Change to Day 29 |
-8.4 (10.4) |
-8.4 (7.3) |
9.7 (11.2) |
-33.5 (10.2) |
|
Difference from Placebo |
|
0 (-30, 30) |
18 (-18, 54) |
-25 (-59, 10) |
Fasting Plasma Insulin (mIU/mL) |
Baseline |
18.0 (2.17) |
15.3 (1.64) |
17.9 (3.19) |
13.3 (1.54) |
|
Change to Day 29 |
-1.8 (1.23) |
-0.7 (0.87) |
-2.5 (1.23) |
-3.1 (1.25) |
|
Difference from Placebo |
|
1.1 (-2.5, 4.7) |
-0.7 (-4.8, 3.4) |
-1.3 (-5.4, 2.9) |
HOMA-IR |
Baseline |
8.5 (1.21) |
6.6 (0.98) |
7.2 (1.28) |
5.6 (0.65) |
|
Change to Day 29 |
-1.4 (0.65) |
-0.5 (0.46) |
-1.9 (0.65) |
-1.9 (0.66) |
|
Difference from Placebo |
|
0.9 (-1.0, 2.8) |
-0.4 (-2.6, 1.7) |
-0.4 (-2.6, 1.8) |
amean (SEM); bleast-squares difference compared to placebo, mean (95% confidence interval); cp<0.050 (Wilcoxon Rank Sum test); dp<0.010 (ANOVA); 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 from baseline, as
pre-specified |
