Original Article
Efficacy and safety of chiglitazar in type 2 diabetes: a multi-center, randomized, double-blind, and parallel group clinical trial
Xiaofeng Lyu, Yongyi Gao, Lyuyun Zhu, Gangyi Yang, Changjiang Wang, Zuojie Luo
Published 2019-05-27
Cite as Chin J Diabetes Mellitus, 2019, 11(5): 334-340. DOI: 10.3760/cma.j.issn.1674-5809.2019.05.005
Abstract
ObjectiveTo evaluate the efficacy and safety of chiglitazarin type 2 diabetic patients with pioglitazone as control group.
MethodsA 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.
ResultsThe 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), but not among these 4 groups (F=0.40-0.75, 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). Moreover, the incidences of adverse events were similar among these 4 groups (P>0.05).
ConclusionChiglitazar 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
Contributor Information
Xiaofeng Lyu
Department of Endocrinology, The Seventh Medical Center of PLA General Hospital, Beijing 100700, China
Yongyi Gao
Department of Endocrinology, Hainan Provincial People′s Hospital, Haikou 570311, China
Lyuyun Zhu
Department of Endocrinology, Bethune International Peace Hospital of PLA, Shijiazhuang 500082, China
Gangyi Yang
Department of Endocrinology, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China
Changjiang Wang
Department of Endocrinology, First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
Zuojie Luo
Department of Endocrinology, First Affiliated Hospital of Guangxi Medical University, Nanning 530021, China