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
Table 3: Summary of Glycemic Parameter Outcomes.