Effect of saroglitazar 2 mg and 4 mg on glycemic control, lipid profile and cardiovascular disease risk in patients with type 2 diabetes mellitus: a 56-week, randomized, double blind, phase 3 study (PRESS XII study)

Table 2 Absolute change in glycemic parameters at week 12, week 24, and week 56 from baseline

Efficacy outcome	Laboratory assessment at study time point	Saroglitazar 2 mg (n = 192) m ± SD	Saroglitazar 4 mg (n = 206) m ± SD	Pioglitazone 30 mg (n = 206) m ± SD
HbA_1C (%)	Absolute change at week 12	− 0.99 ± 1.84*	− 1.21 ± 1.85*	− 1.25 ± 1.88*
	Absolute change at week 24	− 1.38 ± 1.99*	− 1.47 ± 1.92*	− 1.41 ± 1.86*
	Absolute change at week 56	− 1.34 ± 2.01*	− 1.49 ± 1.97*	− 1.47 ± 2.01*
FPG (mg/dL)	Absolute change at week 12	− 2.93 ± 73.34	− 9.23 ± 70.73	− 15.46 ± 69.68*
	Absolute change at week 24	− 0.09 ± 72.72	− 8.09 ± 78.76	− 12.70 ± 67.98*
	Absolute change at week 56	− 17.13 ± 62.04*	− 17.19 ± 70.29*	− 21.13 ± 65.02*
PPG (mg/dL)	Absolute change at week 12	− 33.59 ± 107.06*	− 42.86 ± 102.22*	− 48.60 ± 100.38*
	Absolute change at week 24	− 35.46 ± 108.81*	− 44.36 ± 103.73*	− 45.52 ± 101.73*
	Absolute change at week 56	− 45.98 ± 106.45*	− 43.33 ± 97.54*	− 51.33 ± 107.36*

Absolute change at week 12 = value at week 12 − value at baseline
Absolute change at week 24 = value at week 24 − value at baseline
Absolute change at week 56 = value at week 56 − value at baseline
Primary efficacy endpoint was the absolute change from baseline to week-24 in HbA1c for saroglitazar 2 mg, saroglitazar 4 mg and pioglitazone 30 mg
dL decilitre, FPG fasting plasma glucose, HbA1c glycosylated hemoglobin, mg milligram, m mean, n number of patients, PPG postprandial plasma glucose, SD standard deviation
* Significant difference compared to baseline using paired t-test (p value < 0.05 which is < 0.016 for each treatment group)

ISSN: 1475-2840