Wu Honghua, Liu Jie, Lou Qingqing, Liu Jing, Shen Li, Zhang Mingxia, Lv Xiaofeng, Gu Mingjun, Guo Xiaohui
Department of Endocrinology, Peking University First Hospital, Beijing Department of Endocrinology, Shanxi Provincial People's Hospital, Taiyuan Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou Department of Endocrinology, Gansu Provincial People's Hospital, Lanzhou Department of Endocrinology, Peking University People's Hospital, Beijing Department of Endocrinology, Chinese PLA General Hospital, Beijing Department of Endocrinology, Shanghai Pudong New Area Gongli Hospital, Shanghai, China.
Medicine (Baltimore). 2017 Sep;96(35):e7533. doi: 10.1097/MD.0000000000007533.
This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin.This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376.The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint.Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia.
本研究是糖尿病胰岛素管理组织项目数据的亚组分析，旨在比较阿卡波糖和二甲双胍联合预混胰岛素使用时的疗效和安全性。该分析纳入了仅服用1种口服抗糖尿病药物的80例和192例患者，分别分为阿卡波糖组（接受阿卡波糖+胰岛素治疗）和二甲双胍组（接受二甲双胍+胰岛素治疗）。对组内和组间差异的疗效和安全性数据进行了分析。临床试验注册号为NCT01338376。经过16周治疗后，阿卡波糖组和二甲双胍组达到目标糖化血红蛋白（HbA1c）<7%的患者百分比分别为38.75%和30.73%。阿卡波糖组和二甲双胍组的平均HbA1c水平在基线时相当，且在研究结束时两组均显著下降。与基线时相比，两组在终点时所有7次血糖均显著下降。二甲双胍组的胰岛素总日用量和每千克体重的用量更高。两组低血糖发生率相似。两组从基线到终点体重均有显著变化，但组间无显著差异。两组在终点时的Morisky药物依从性量表平均得分均有所改善。胰岛素与阿卡波糖或二甲双胍联合使用可改善2型糖尿病患者的血糖控制。阿卡波糖和二甲双胍在疗效、体重增加和低血糖发生率方面相当。
