Objective To demonstrate the efficacy, tolerability, and safety of domestic Acarbose tablet compared with Glucobay (Acarbose tablet produced by Bayer company) in patients with type 2 diabetic patients.
Method A multicenter randomized controlled parallel-group comparison study was conducted. 177 Chinese type 2 diabetic patients were recruited from 4 clinical centers. The patients were divided randomly into domestic Acarbose tablet (A group) or Glucoby (B group) treatment group. The trial consisted of a 2-4 weeks equilibrated period followed by an 8 week course of treatment.
Results 165 patients have finished the trial (81 in A group and 84 in B group). After 4 weeks of treatment, the mean of fasting blood glucose (FBG) in A and B group were reduced 1.61 and 2.08 mmol/L respectively, and mean of postprandial blood glucose (PBG) lowered 5.06 and 5.09mmol/L respectively. After 8 weeks of treatment, the mean of FBG were reduced 1.95 and 2.62mmol/L respectively, and mean of PBG lowered 4.88 and 5.98 mmol/L, respectively, and mean of HbA1c were lowered 1.13% and 1.20% respectively in A and B group. The differences in reduction of FBG, PBG, and HbA1c between A and B group were no statistic significance. The serum triglyceride levels and BMI were decreased significantly in both A, B groups. 3 patients who drinking wine during trial on A group had asymptomatic elevations in serum transaminases that normalized in 2 weeks after stopped drinking and Acarbose withdrawal. Flatulence was the most common side effect.
Conclusions In this multicenter study, domestic Acarbose tablet 50 mg t.i.d. was an effective, safe, and generally well-tolerated therapy as similar as Glucobay in type 2 diabetic patients.
Citation： TIAN Haoming,LU Yuechan,WU Tong,LI Weidon,RAN Xingwu,HAN Rei,YU Hongling,REN Yan,CHENG Ping,PU Ling,YIN Xiaohong. Comparison of efficacy and safety of the domestic acarbose tablet with glucoby in type 2 diabetic patients--randomized controlled trial. Chinese Journal of Evidence-Based Medicine, 2003, 03(1): 10-17. doi: Copy