Ikeda Yukio, Tsukube Shoko, Kadowaki Takashi, Odawara Masato
Sanofi K.K., Tokyo Opera City Tower, 3-20-2 Nishi-shinjyuku, Shinjyuku-ku, Tokyo, 163-1488 Japan.
2Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan.
Diabetol Int. 2015 Oct 5;7(2):188-198. doi: 10.1007/s13340-015-0236-9. eCollection 2016 Jun.
We aimed to identify diabetes-related factors associated with achieving HbA1c <7.0 % after the initiation of basal supported oral therapy (BOT) in insulin-naïve type 2 diabetes patients with an HbA1c value of ≥6.5 % during the previous 4 weeks, using data from Add-on Lantus to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week observational study on Japanese type 2 diabetes patients.
Patients were categorized into two groups: HbA1c <7.0 % at the final evaluation point (at 24 weeks or the last visit) as HbA1c-target-achieved; HbA1c ≥7.0 % as target-not-achieved. Associations between baseline factors and HbA1c <7.0 % achievement were explored using logistic regression.
Of the 1520 patients in the study, 400 patients (26.3 %) achieved HbA1c <7.0 %. Patients with diabetes duration of <1 year and between ≥1 and <2 years [odds ratio (OR): 5.27, 95 % confidence interval (CI): 1.13-24.51; OR: 3.77, 95 % CI 1.19-11.93, respectively], those on one pre-study orally administered antidiabetic agent (OAD) (OR: 2.42, 95 % CI 1.12-5.22), and those with absence of diabetic neuropathy (OR: 2.54, 95 % CI 1.12-5.76) were more likely to achieve HbA1c <7.0 % than those with duration of ≤15 years, ≥4 pre-study OADs, and neuropathy, respectively. Achievement of HbA1c <7.0 % among patients increased by approximately 20 % for each 1 % decrease in HbA1c level at baseline.
Shorter diabetes duration, pre-study regimen of one OAD, absence of neuropathy, and lower HbA1c level at baseline were associated with achievement of HbA1c <7.0 %, suggesting that earlier initiation of BOT leads to good HbA1c control in insulin-naïve Japanese type 2 diabetes patients, consistent with our early ALOHA study.
我们旨在利用“甘精胰岛素联合口服降糖药2(ALOHA2)研究”的数据,确定在起始基础支持口服治疗(BOT)后糖化血红蛋白(HbA1c)<7.0%的糖尿病相关因素。该研究是一项针对日本2型糖尿病患者的为期24周的观察性研究,研究对象为之前4周内HbA1c值≥6.5%的初治2型糖尿病患者。
将患者分为两组:在最终评估点(24周或最后一次就诊时)HbA1c<7.0%为达到HbA1c目标;HbA1c≥7.0%为未达到目标。使用逻辑回归分析探索基线因素与HbA1c<7.0%达标之间的关联。
在该研究的1520例患者中,400例患者(26.3%)达到了HbA1c<7.0%。糖尿病病程<1年以及≥1至<2年的患者[比值比(OR):5.27,95%置信区间(CI):1.13 - 24.51;OR:3.77,95%CI 1.19 - 11.93]、研究前服用一种口服降糖药(OAD)的患者(OR:2.42,95%CI 1.12 - 5.22)以及无糖尿病神经病变的患者(OR:2.54,95%CI 1.12 - 5.76)分别比病程≤15年、研究前服用≥4种OAD以及有神经病变的患者更有可能达到HbA1c<7.0%。基线时HbA1c水平每降低1%,患者中达到HbA1c<7.0%的比例增加约20%。
较短的糖尿病病程、研究前服用一种OAD的治疗方案、无神经病变以及较低的基线HbA1c水平与HbA1c<7.0%的达标相关,这表明在初治的日本2型糖尿病患者中更早开始BOT可实现良好的HbA1c控制,这与我们早期的ALOHA研究结果一致。