China-Japan Friendship Hospital, Beijing, China.
Shanxi Province People's Hospital, Taiyuan, China.
Lancet Diabetes Endocrinol. 2014 Jan;2(1):46-55. doi: 10.1016/S2213-8587(13)70021-4. Epub 2013 Oct 18.
Metformin is the only first-line oral hypoglycaemic drug for type 2 diabetes recommended by international guidelines with proven efficacy, safety, and cost-effectiveness. However, little information exists about its use in Asian populations. We aimed to ascertain the effectiveness of the α-glucosidase inhibitor acarbose, extensively adopted in China, compared with metformin as the alternative initial therapy for newly diagnosed type 2 diabetes.
In this 48-week, randomised, open-label, non-inferiority trial, patients who were newly diagnosed with type 2 diabetes, with a mean HbA1c of 7·5%, were enrolled from 11 sites in China. After a 4-week lifestyle modification run-in, patients were assigned to 24 weeks of monotherapy with metformin or acarbose as the initial treatment, followed by a 24-week therapy phase during which add-on therapy was used if prespecified glucose targets were not achieved. Primary endpoints were to establish whether acarbose was non-inferior to metformin in HbA1c reduction at week 24 and week 48 timepoints. The non-inferiority margin was 0·3%, with an expected null difference in the change from baseline to week 48 in HbA1c. Analysis was done on a modified intention-to-treat population. This study was registered with Chinese Clinical Trial Registry, number ChiCTR-TRC-08000231.
Of the 788 patients randomly assigned to treatment groups, 784 patients started the intended study drug. HbA1c reduction at week 24 was -1·17% in the acarbose group and -1·19% in the metformin group. At week 48, the HbA1c reduction was -1·11% (acarbose) and -1·12% (metformin) with difference 0·01% (95% CI -0·12 to 0·14, p=0·8999). Six (2%) patients in the acarbose group and seven (2%) patients in the metformin group had serious adverse events, and two (1%) and four (1%) had hypoglycaemic episodes.
This study provides evidence that acarbose is similar to metformin in efficacy, and is therefore a viable choice for initial therapy in Chinese patients newly diagnosed with type 2 diabetes.
Bayer Healthcare (China) and Double Crane Phama.
二甲双胍是国际指南推荐的唯一一种具有疗效、安全性和成本效益的一线口服降糖药，适用于 2 型糖尿病。然而，关于它在亚洲人群中的应用的信息很少。我们旨在确定广泛应用于中国的α-葡萄糖苷酶抑制剂阿卡波糖作为新诊断 2 型糖尿病的替代初始治疗，与二甲双胍相比是否具有有效性。
在这项为期 48 周的随机、开放标签、非劣效性试验中，招募了来自中国 11 个地点的新诊断为 2 型糖尿病、平均 HbA1c 为 7.5%的患者。经过 4 周的生活方式调整导入期后，患者被分配到为期 24 周的单药治疗，分别使用二甲双胍或阿卡波糖作为初始治疗，随后是 24 周的治疗期，如果未达到预设的血糖目标，则使用添加治疗。主要终点是确定阿卡波糖在第 24 周和第 48 周的 HbA1c 降低方面是否不劣于二甲双胍。非劣效性边界为 0.3%，预计 HbA1c 从基线到第 48 周的变化为零差异。分析采用改良意向治疗人群进行。这项研究在中国临床试验注册中心注册，编号 ChiCTR-TRC-08000231。
在随机分配到治疗组的 788 名患者中，784 名患者开始接受预期的研究药物治疗。阿卡波糖组在第 24 周的 HbA1c 降低为-1.17%，二甲双胍组为-1.19%。在第 48 周时，HbA1c 降低分别为-1.11%（阿卡波糖）和-1.12%（二甲双胍），差值为 0.01%（95%CI -0.12 至 0.14，p=0.8999）。阿卡波糖组有 6 名（2%）患者和二甲双胍组有 7 名（2%）患者发生严重不良事件，阿卡波糖组有 2 名（1%）和二甲双胍组有 4 名（1%）发生低血糖事件。
这项研究提供了证据表明，阿卡波糖在疗效上与二甲双胍相似，因此是中国新诊断为 2 型糖尿病患者初始治疗的可行选择。
拜耳医疗保健（中国）和双鹤药业。
