RESUMEN
OBJECTIVE: To assess the efficacy, tolerability, and safety of the domestic Acarbose capsule (DAC, produced by Luzhou Baoguang Pharmaceutical Co. LTD) in treating patients with type 2 diabetes mellitus. METHODS: One hundred and seventy nine type 2 diabetic patients were randomly divided into DAC (group A, 89 patients) and Glucoby (group B, 90 patients) treatment groups. The trial consisted of a 2-4 weeks equilibrated period followed by an 8 week course of treatments. All of the patients were followed up at the 4th week and 8th week after the commencement of the treatments. One hundred and sixty five patients completed the trial, with 81 in group A and 84 in group B. RESULTS: At the 4th week of the treatments, an average reduction of 1.81 and 2.08 mmol/L of fasting blood glucose (FBG) was found in group A and group B, respectively (P > 0.05); and an average reduction of 5.43 and 5.09 mmol/ L of postprandial blood glucose (PBG) was found in group A and group B, respectively (P > 0.05). At the 8th week, an average reduction of 2.35 and 2.62 mmol/L FBG was found in group A and group B, respectively (P > 0.05); and an average of reduction of 5.93 and 5.98 mmol/L of PBG was found in group A and group B, respectively (P > 0.05); The mean HbA(1c) was lowered by 1.07% and 1.20% by DAC and Glucoby respectively (P > 0.05). The incidence rate of side effects in group A was 32.53%, less than that in group B (48.81%). Flatulence was the most common side effect. The clinical effects of both Glucoby and DAC were more significant at the 8th week than at the 4th week. CONCLUSION: DAC is as effective and safe as Glucobay for treating type 2 diabetic patients.