Diabetes Centre, Heart of England NHS Foundation Trust, Birmingham, UK; University of Birmingham, Birmingham, UK.
Lancet. 2013 Oct 26;382(9902):1413-23. doi: 10.1016/S0140-6736(13)61500-7. Epub 2013 Aug 13.
A substantial proportion of patients with type 2 diabetes are elderly (≥65 years) but this group has been largely excluded from clinical studies of glucose-lowering drugs. We aimed to assess the effectiveness of linagliptin, a dipeptidyl peptidase-4 inhibitor, in elderly patients with type 2 diabetes.
In this randomised, double-blind, parallel-group, multinational phase 3 study, patients aged 70 years or older with type 2 diabetes, glycated haemoglobin A1c (HbA1c) of 7·0% or more, receiving metformin, sulfonylureas, or basal insulin, or combinations of these drugs, were randomised (by computer-generated randomisation sequence, concealed with a voice-response system, stratified by HbA1c level [<8·5% vs ≥8·5%] and insulin use [yes vs no], block size four) in a 2:1 ratio to once-daily oral treatment with linagliptin 5 mg or matching placebo for 24 weeks. Investigators and participants were masked to assignment throughout the study. The primary endpoint was change in HbA1c from baseline to week 24. This trial is registered with ClinicalTrials.gov, number NCT01084005.
241 community-living outpatients were randomised (162 linagliptin, 79 placebo). Mean age was 74·9 years (SD 4·3). Mean HbA1c was 7·8% (SD 0·8). At week 24, placebo-adjusted mean change in HbA1c with linagliptin was -0·64% (95% CI -0·81 to -0·48, p<0·0001). Overall safety and tolerability were much the same between the linagliptin and placebo groups; 75·9% of patients in both groups had an adverse event (linagliptin n=123, placebo n=60). No deaths occurred. Serious adverse events occurred in 8·6% (14) of patients in the linagliptin group and 6·3% (five) patients in the placebo group; none were deemed related to study drug. Hypoglycaemia was the most common adverse event in both groups, but did not differ between groups (24·1% [39] in the linagliptin group, 16·5% [13] in the placebo group; odds ratio 1·58, 95% CI 0·78-3·78, p=0·2083).
In elderly patients with type 2 diabetes linagliptin was efficacious in lowering glucose with a safety profile similar to placebo. These findings could inform treatment decisions for achieving individualised glycaemic goals with minimal risk in this important population of patients.
Boehringer Ingelheim.
相当一部分 2 型糖尿病患者为老年人（≥65 岁），但这类人群在降糖药物的临床研究中基本被排除在外。我们旨在评估二肽基肽酶-4 抑制剂利格列汀在老年 2 型糖尿病患者中的疗效。
这是一项随机、双盲、平行分组、多国 3 期研究，纳入了年龄≥70 岁、糖化血红蛋白（HbA1c）水平≥7.0%、正在接受二甲双胍、磺酰脲类药物或基础胰岛素治疗或上述药物联合治疗的 2 型糖尿病患者，按 HbA1c 水平（＜8.5% vs. ≥8.5%）和是否使用胰岛素（是 vs. 否）分层，按 2:1 的比例随机分配，接受每日一次口服利格列汀 5mg 或匹配安慰剂治疗 24 周。研究人员和参与者在整个研究过程中对分组情况均设盲。主要终点为从基线到第 24 周时 HbA1c 的变化。该试验在 ClinicalTrials.gov 注册，编号为 NCT01084005。
241 例社区居住的门诊患者被随机分配（162 例利格列汀，79 例安慰剂）。平均年龄为 74.9 岁（SD 4.3）。平均 HbA1c 为 7.8%（SD 0.8）。第 24 周时，利格列汀治疗组 HbA1c 较基线的平均变化为-0.64%（95%CI -0.81 至-0.48，p＜0.0001）。利格列汀组和安慰剂组的总体安全性和耐受性基本相似；两组中均有 75.9%（123/162）的患者发生不良事件（利格列汀组 14 例死亡，安慰剂组 6 例）。无死亡事件发生。利格列汀组 8.6%（14/162）的患者和安慰剂组 6.3%（5/79）的患者发生严重不良事件，但均被认为与研究药物无关。低血糖是两组中最常见的不良事件，但两组间无差异（利格列汀组 24.1%[39/162]，安慰剂组 16.5%[13/79]；比值比 1.58，95%CI 0.78-3.78，p=0.2083）。
在老年 2 型糖尿病患者中，利格列汀能有效降低血糖，且安全性与安慰剂相似。这些发现可为这一重要患者人群实现个体化血糖目标并将风险最小化的治疗决策提供信息。
勃林格殷格翰。
