Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double-blinded, double-dummy positive controlled trial

• Published in: Journal of evidence-based medicine 2012-08, Vol.5 (3), p.134-138
• Main Authors: Wu, Qian Lin, Liu, Yu Ping, Lu, Ju Ming, Wang, Chang Jiang, Yang, Tao, Dong, Ji Xiang, Li, Cheng Jiang, Ma, Jian Hua, Xue, Yao Ming, Sun, Rui Hua, Wei, Dong, Tian, Hao Ming
• Format: Article
• Language: English
• Subjects: Acarbose; Acarbose - adverse effects; Acarbose - therapeutic use; Blood Glucose - analysis; chewable tablet; Diabetes Mellitus, Type 2 - drug therapy; Double-Blind Method; Glycated Hemoglobin A - analysis; Humans; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; multicentre randomized controlled trial; positive control; type 2 diabetes
• ISSN: 1756-5383; 1756-5391; 1756-5391
• DOI: 10.1111/j.1756-5391.2012.01188.x

Objective: To evaluate the effect and safety of HbA1c and glycemic control of acarbose chewable tablets in patients with type 2 diabetic. Method: A multicentre, randomized, double‐blinded, double‐dummy, positive controlled clinical trial was conducted. Two hundred thirty‐four Chinese patients with type 2 diabetic were enrolled in eight clinical centres, who were divided randomly into the acarbose chewable tablet group (experimental group, n = 116) and the acarbose treatment group (control group, n = 118). Results: Two hundred seven patients (88.5%) took part in the 12‐week trial. At the beginning and end of the clinical trial, HbA1c and blood glucose as well as safety indexes were measured. After the treatment, the level of finger two‐hour postprandial blood glucose (PPBG) was decreased 4.15 mmol/L (26.82%) and 3.54 mmol/L (22.77%), respectively, in the experiment group and the control group. The levels of venous two‐hour PPBG in the experiment group and the control group were decreased 4.04 mmol/L (25.38%) and 2.75 mmol/L (17.26%), respectively, with the means of HbA1c lowering 11.67% and 12.44%, respectively. Fasting blood glucose (FBG) also was reduced significantly in both groups. Patients in both groups showed obvious weight reduction (P < 0.0001). There were no significant differences in the incidence of adverse events between the two groups. Conclusion: In summary, acarbose chewable tablets have a definite curative effect in treating type 2 diabetic patients as HbA1c and blood glucose levels decreased significantly after the 12‐week treatment.