Efficacy, safety of acarbose combined with other anti-diabetic drugs in the treatment of type 2 diabetic patients: an open, self-controlled, non-randomized, multi-center study with other anti-diabetic drugs study

Abstract

Objective To evaluate the efficacy and safety of acarbose treatment in combination with other anti-diabetic drugs in Chinese type 2 diabetic patients under day-to-day practice conditions. Methods 493 patients were enrolled by 17 centers throughout China into an open,self-controlled,non-randomized,multi-center study. Main efficacious parameters were the changes in fasting blood glucose (FBG) and postprandial blood glucose (PBG) concentrations as well as in HbA1c levels after acarbose treatment. All patients had been previously treated with other oral anti-diabetic medication without achieving the glycemic target and received concomitant anti-diabetics during the observation period of 12 weeks. Results After 12 weeks of treatment, FBG and PBG after three meal, as well as HbA1c of all patients decreased 1.3 mmol/L,3.3 mmol/L,3.2 mmol/L,3.44 mmol/L,0.90% respectively(P＜0.001). The levels of FBG in the three sub-groups:acarbose combined with non-insulin secretagogues, acarbose combined with sulphonylurea or acarbose combined with glinide decreased 1.24 mmol/L, 1.30 mmol/L and 1.13 mmol/L respectively; PBG after breakfast decreased 3.36 mmol/L, 3.35 mmol/L and 2.25 mmol/L; PBG after lunch decreased 3.57 mmol/L,3.61 mmol/L and 3.15 mmol/L; PBG after dinner decreased 3.65 mmol/L,3.48 mmol/L and 3.09 mmol/L; HbAlc decreased 0.99% ,1.06% and 1.01% ,respectively in these three groups. No serious adverse effects such as serious hypoglycemia, hepatic dysfunction were observed except 3.6% patients complained abdominal distension,but all were tolerant. Conclusion Acarbose is efficacious, safe and well tolerant for Chinese type 2 diabetic patients under combination with other anti-diabetic drugs. Key words: Type 2 diabetes mellitus; Acarbose; Glycemic control; Combined medication