Table 3.
Change from baseline in glycosylated hemoglobin and fasting plasma glucose between treatment groups
Efficacy outcome | Week | Treatment | n | Mean ± SD | LS mean difference of change from baseline saroglitazar vs. pioglitazone |
|||
---|---|---|---|---|---|---|---|---|
Estimate | Standard error | 95% confidence interval | p-values | |||||
HbA1C (%) | week 12 | Saroglitazar 2 mg | 192 | 8.77 ± 1.86 | 0.40 | 0.17 | (0.08, 0.73) | 0.0156 |
Saroglitazar 4 mg | 206 | 8.51 ± 1.57 | 0.18 | 0.15 | (− 0.12, 0.48) | 0.2368 | ||
week 24 | Saroglitazar 2 mg | 192 | 8.38 ± 1.66 | 0.23 | 0.16 | (− 0.08, 0.54) | 0.1536 | |
Saroglitazar 4 mg | 206 | 8.25 ± 1.61 | 0.10 | 0.15 | (− 0.19, 0.40) | 0.4924 | ||
week 56 | Saroglitazar 2 mg | 192 | 8.42 ± 1.84 | 0.31 | 0.17 | (− 0.03, 0.65) | 0.0698 | |
Saroglitazar 4 mg | 206 | 8.23 ± 1.73 | 0.15 | 0.16 | (− 0.18, 0.47) | 0.3742 | ||
FPG (mg/dL) | week 12 | Saroglitazar 2 mg | 192 | 163.15 ± 70.14 | 13.31 | 6.26 | (1.00, 25.61) | 0.0341 |
Saroglitazar 4 mg | 206 | 156.18 ± 60.92 | 6.55 | 5.72 | (− 4.69, 17.79) | 0.2524 | ||
week 24 | Saroglitazar 2 mg | 192 | 165.98 ± 67.44 | 13.28 | 6.24 | (1.01, 25.54) | 0.0340 | |
Saroglitazar 4 mg | 206 | 157.32 ± 67.98 | 4.85 | 6.23 | (− 7.39, 17.09) | 0.4363 | ||
week 56 | Saroglitazar 2 mg | 192 | 148.95 ± 52.41 | 4.76 | 5.18 | (− 5.42, 14.93) | 0.3587 | |
Saroglitazar 4 mg | 206 | 148.22 ± 60.25 | 4.18 | 5.47 | (− 6.57, 14.94) | 0.4447 |
Estimate, standard error, p-values and 95% CI are calculated based on ANCOVA (Analysis of Covariance)
n number of subjects in the specified category, LS least square