Sheu Wayne H-H, Park Sung Woo, Gong Yan, Pinnetti Sabine, Bhattacharya Sudipta, Patel Sanjay, Seck Thomas, Woerle Hans-Juergen
Taichung Veterans General Hospital , Taichung , Taiwan.
Curr Med Res Opin. 2015 Mar;31(3):503-12. doi: 10.1185/03007995.2015.1010638. Epub 2015 Feb 13.
To evaluate the efficacy and long-term safety of linagliptin added to basal insulin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin with/without oral agents.
This was a post hoc analysis of Asian patients from a global ≥52 week study in which patients on basal insulin were randomized (1:1) to double-blind treatment with linagliptin 5 mg once daily or placebo (NCT00954447). Basal insulin dose remained stable for 24 weeks, after which adjustments could be made according to the investigator's discretion to improve glycemic control. The primary endpoint was the mean change in glycated hemoglobin (HbA1c) from baseline to 24 weeks.
Data were available for 154 Asian patients (80 linagliptin, 74 placebo). Baseline HbA1c (standard deviation [SD]) was 8.6 (0.9)% (70 [10] mmol/mol). The placebo-corrected mean change (standard error [SE]) in HbA1c from baseline was -0.9 (0.1)% (-10 [1] mmol/mol) (95% confidence interval [CI]: -1.2, -0.7; p<0.0001) at Week 24 and -0.9 (0.1)% (-10 [1] mmol/mol) (95% CI: -1.1, -0.6; p<0.0001) at Week 52. The frequency of adverse events (linagliptin 81.3%, placebo 91.9%) and hypoglycemia (Week 24: linagliptin 25.0%, placebo 25.7%; treatment end: linagliptin 28.8%, placebo 35.1%) was similar between groups. By Week 52, changes (SE) in mean body weight were similar in both groups (linagliptin -0.67 [0.26] kg, placebo -0.38 [0.25] kg).
This study was limited by the post hoc nature of the analysis and the small number of patients in the subgroup. However, the results suggest that linagliptin significantly improves glycemic control in Asian patients with T2DM inadequately controlled by basal insulin, without increasing the risk for hypoglycemia or weight gain. ClinicalTrials identifier: NCT00954447.
评估在亚洲2型糖尿病（T2DM）患者中，在基础胰岛素治疗（联合或不联合口服药物）血糖控制不佳时，加用利格列汀的疗效及长期安全性。
这是一项对来自一项全球≥52周研究中的亚洲患者的事后分析，在该研究中，接受基础胰岛素治疗的患者被随机（1:1）分为两组，分别接受每日一次5mg利格列汀的双盲治疗或安慰剂治疗（NCT00954447）。基础胰岛素剂量在24周内保持稳定，此后可根据研究者的判断进行调整以改善血糖控制。主要终点是糖化血红蛋白（HbA1c）从基线到24周的平均变化。
共有154例亚洲患者的数据可用（利格列汀组80例，安慰剂组74例）。基线HbA1c（标准差[SD]）为8.6（0.9）%（70[10]mmol/mol）。在第24周时，HbA1c从基线的安慰剂校正平均变化（标准误[SE]）为-0.9（0.1）%（-10[1]mmol/mol）（95%置信区间[CI]：-1.2，-0.7；p<0.0001），在第52周时为-0.9（0.1）%（-10[1]mmol/mol）（95%CI：-1.1，-0.6；p<0.0001）。两组间不良事件（利格列汀组81.3%，安慰剂组91.9%）和低血糖（第24周：利格列汀组25.0%，安慰剂组25.7%；治疗结束时：利格列汀组28.8%，安慰剂组35.1%）的发生率相似。到第52周时，两组平均体重的变化（SE）相似（利格列汀组-0.67[0.26]kg，安慰剂组-0.38[0.25]kg）。
本研究受分析的事后性质及亚组患者数量较少的限制。然而，结果表明，利格列汀可显著改善基础胰岛素治疗血糖控制不佳的亚洲T2DM患者的血糖控制，且不增加低血糖或体重增加的风险。临床试验标识符：NCT00954447。
