[A multicenter randomized controlled clinical trial on blood glucose lowering effects of domestic Acarbose (capsule) in type 2 diabetic patients].
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.


CONCLUSIONS
DAC is as effective and safe as Glucobay for treating type 2 diabetic patients.
Ran
Xing-wu
XW
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China.
Zhang
De-cui
DC
Tian
Hao-ming
HM
Chen
Ping
P
Pu
Lin
L
Li
Wei-dong
WD
D020909:Acarbose / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D001786:Blood Glucose / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D020909:Acarbose