Efficacy and safety of chiglitazar in type 2 diabetes: a multi-center, randomized, double-blind, and parallel group clinical trial

Objective To evaluate the efficacy and safety of chiglitazarin type 2 diabetic patients with pioglitazone as control group. Methods A multi-center (6 hospitals), randomized, double-blind, and parallel controlled clinical trial was carried out from November 2009 to November 2010. A total of 200 patients with newly diagnosed type 2 diabetes [glycated hemoglobin A1c (HbA1c): 7%-10%] were randomized to take 32, 40, 48 mg chiglitazar or 30 mg pioglitazone, respectively. At baseline and the 16th week, the levels of HbA1c, fasting plasma glucose (FPG), 2 h post prandial piasma glucose (2h-PPG), insulin and lipid profiles were measured and adverse events were observed. Analysis of variance was used for comparison between groups and paired t-test was used for intra-group comparison. Results The reduction differences were statistically significant from baseline to the 16th week at doses of 32, 40, 48 mg chiglitazar or 30 mg pioglitazone groups (t=-8.16-3.58, all P 0.05). The least squares mean and 95% confidence intervals of HbA1c, FPG and 2h-PPG in the four groups were as follow respectively: HbA1c [-1.03% (-1.30, -0.77)%, -1.22% (-1.48, -0.96)%, -1.11% (-1.37, -0.85)% and -1.18% (-1.44, -0.91)%]; FPG[-1.79 (-2.43, -1.16), -1.82 (-2.44, -1.20), -1.76 (-2.37, -1.14) and -2.01(-2.64, -1.39)] mmol/L; 2h-PPG[-2.42 (-3.37, -1.47), -2.09 (-3.01, -1.16), -2.77 (-3.70, -1.84) and -3.11 (-4.06, -2.17)] mmol/L. Significant reductions from baseline to the 16th week were observed in triglycerides dose of 40 and 48 mg chiglitazar group and in cholesterol at dose of 32 mg chiglitazar group, while a slightly significant increase in HDL-C was observed in each of these 4 groups (t=2.40-3.88, all P 0.05). Conclusion Chiglitazar is noninferior to pioglitazone in hypoglycemin effects for patients with type 2 diabetes. Both drugs have similar safety and tolerance. Key words: Diabetes mellitus, type 2; Chiglitazar; Effectiveness; Safety