Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus.
Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus.
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DOI：
10.1186/s12883-018-1014-7
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发表时间：
2018-01-15
期刊：
影响因子：
2.6
通讯作者：
CAROLINA® investigators
中科院分区：
文献类型：
--
作者：
Biessels GJ;Janssen J;van den Berg E;Zinman B;Espeland MA;Mattheus M;Johansen OE;CAROLINA® investigators
2型糖尿病与认知功能障碍和痴呆风险增加有关。利格列汀是一种二肽基肽酶-IV（DPP-IV）抑制剂类降糖药，特别关注其预防加速认知功能减退，因为除降糖作用外，利格列汀还可能通过多效性作用对大脑有益。本文介绍了一项旨在确定利格列汀在预防2型糖尿病患者认知功能加速下降方面是否上级磺脲类药物格列美脲的研究设计。认知子研究是正在进行的事件驱动、随机、双盲利格列汀心血管安全性（卡罗莱纳®）试验的组成部分，该试验评价了利格列汀与格列美脲治疗对心血管结局的影响。卡罗莱纳®包括血糖控制欠佳、心血管风险升高的2型糖尿病患者。该子研究将评价基线简易精神状态检查（MMSE）评分≥ 24、记录的正规教育年限以及基线和随访期间至少一次有效认知评估的随机化和治疗患者。主要认知结局是随访结束时认知功能加速下降。将使用logistic回归对两个治疗组进行比较。认知功能加速下降定义为认知功能下降率福尔斯等于或低于整个队列在MMSE或连线和语言流畅性测试的组合评分上下降的第16百分位数。使用基于回归的指数，在个体患者水平考虑潜在混杂因素。2010年12月至2012年12月期间，6042例患者接受随机分配，接受利格列汀（5 mg）或格列美脲（1-4 mg）每日一次卡罗莱纳®治疗。在基线时对近4500名参与者进行了认知测试，并计划在160周的随访和随访结束后进行两次后续评估。正在进行的卡罗莱纳®试验的这一子研究将确定利格列汀在预防2型糖尿病患者认知功能加速下降方面是否优于格列美脲（上级）。最终结果预计将于2019年公布。ClinicalTrials.gov标识符：NCT 01243424。本文的在线版本（10.1186/s12883-018-1014-7）包含补充材料，可供授权用户使用。
Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. The cognition substudy is an integral part of the ongoing event-driven, randomised, double blind CARdiOvascular safety of LINAgliptin (CAROLINA®) trial, which evaluates the effect of treatment with linagliptin versus glimepiride on cardiovascular outcomes. CAROLINA® includes patients with type 2 diabetes mellitus with sub-optimal glycaemic control at elevated cardiovascular risk. The substudy will evaluate patients randomised and treated who have a baseline Mini Mental State Examination (MMSE) score ≥ 24, documented years of formal education with at least one valid cognitive assessment at baseline and during follow-up. The primary cognitive outcome is the occurrence of accelerated cognitive decline at the end of follow-up. The two treatment groups will be compared by using a logistic regression. Accelerated cognitive decline is defined as a rate of cognitive decline that falls at or below the 16th percentile of decline for the whole cohort on either the MMSE or a combined score of the trail making and verbal fluency test. Potential confounders are taken into account at an individual patient level, using a regression based index. Between December 2010 and December 2012, 6042 patients were randomised and treated with either linagliptin (5 mg) or glimepiride (1-4 mg) once daily in CAROLINA®. Cognitive tests were conducted in nearly 4500 participants at baseline and are scheduled for two subsequent assessments, after 160 weeks of follow-up and end of follow-up. This substudy of the ongoing CAROLINA® trial will establish if linagliptin is superior to glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. Final results are expected in 2019. ClinicalTrials.gov Identifier: NCT 01243424. The online version of this article (10.1186/s12883-018-1014-7) contains supplementary material, which is available to authorized users.
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