- 作者：Jun-Sing Wang ; Chien-Ning Huang ; Yi-Jen Hung ; Ching-Fai Kwok ; Jui-Hung Sun ; Dee Pei ; Chwen-Yi Yang ; Ching-Chu Chen ; Ching-Ling Lin ; Wayne Huey-Herng Sheu ; the acarbose/metformin fixed-dose combination study investigators
- 关键词：Alpha-glucosidase inhibitor ; Combination ; Diabetes ; Glycaemic control ; Metformin
- 刊名：Diabetes Research and Clinical Practice
- 出版年：2013
- 出版时间：October, 2013
- 年：2013
- 卷：102
- 期：1
- 页码：16-24
- 全文大小：747 K
Aim
To compare the efficacy and safety of acarbose plus metformin fixed-dose combination (FDC) versus acarbose monotherapy for type 2 diabetes (T2D).Methods
Eligible T2D patients undergoing treatment with diet control only or oral antidiabetic medications were run-in on acarbose 50 mg thrice-daily for 4 weeks, then randomised either to continue this monotherapy, or to acarbose 50 mg plus metformin hydrochloride 500 mg FDC (acarbose/metformin FDC), each thrice-daily for 16 weeks.
Results
Acarbose/metformin FDC therapy significantly reduced HbA1c, fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) from baseline (all p < 0.0001) with superior efficacy compared with acarbose monotherapy (between-group differences; HbA1c ?1.35 % ; FPG ?29.5 mg/dl; PPG ?41.6 mg/dl; all p < 0.0001). Proportionally more patients treated with acarbose/metformin FDC achieved HbA1c <7.0 % (47.8 % vs. 10.7 % , p < 0.0001). Both treatments reduced bodyweight (p < 0.0001), with a significant between-group difference (?0.6 kg, p < 0.01) favouring acarbose/metformin FDC. Hypoglycaemia was not reported with either treatment, and the incidence of other adverse events did not differ significantly between the groups.
Conclusions
Compared with acarbose monotherapy, acarbose/metformin FDC has superior antihyperglycaemic efficacy, brings proportionally more T2D patients to HbA1c goal, and further reduces bodyweight. Acarbose/metformin FDC is well-tolerated without significant risk of hypoglycaemia and is a potentially advantageous therapy for T2D.