Department of Diabetes, Endocrinology and Metabolism, Royal North Shore Hospital, Sydney, NSW, Australia.
Northern Clinical School, University of Sydney, Sydney, NSW, Australia.
Endocrine. 2021 Dec;74(3):530-537. doi: 10.1007/s12020-021-02887-8. Epub 2021 Oct 12.
IDegAsp, a co-formulation of long-acting basal (insulin degludec) and rapid-acting bolus (insulin aspart) insulin, provides separate prandial and basal glucose-lowering effects with relatively low risk of hypoglycaemia. Its efficacy and safety have been investigated in a large clinical trial programme (BOOST). We present the rationale and design of the ARISE study, which aims to assess glycaemic control and other clinical parameters associated with IDegAsp use in real world.
ARISE is a ~26-wk-long, prospective, non-interventional, single-arm study of patients with type 2 diabetes (T2D) initiating IDegAsp treatment. Approximately 1112 patients with T2D aged ≥18 years previously on anti-hyperglycaemic drugs except IDegAsp will be enroled across six countries from 15 Aug 2019 to 12 Nov 2020. IDegAsp treatment will be initiated at the physicians' discretion and as per the local label. Key exclusion criteria include previous participation, or previous IDegAsp treatment. The primary and secondary endpoints are change in HbA from baseline (wk 0) to study end (wk 26-36) and the proportion of patients achieving the target HbA level of <7% at the study end, respectively. A mixed model for repeated measurements will analyse the primary endpoint.
Between-country differences in the prescription patterns of glucose-lowering agents in people with T2D warrant examination of their clinical use in different geographical settings. The ARISE study is designed to assess the clinical use of IDegAsp from real world in six different countries. Findings from the ARISE study will supplement those of previous randomised controlled studies by establishing real-world evidence of IDegAsp use in the participating countries.
ClinicalTrials.gov, NCT04042441. Registered 02 August 2014, https://clinicaltrials.gov/ct2/show/NCT04042441.
IDegAsp 是一种长效基础（胰岛素德谷）和速效餐时（胰岛素门冬）胰岛素的联合制剂，具有相对较低的低血糖风险，可提供单独的餐时和基础血糖降低作用。其疗效和安全性已在一项大型临床试验项目（BOOST）中得到验证。我们介绍了 ARISE 研究的原理和设计，该研究旨在评估 IDegAsp 在真实世界中的使用与血糖控制和其他临床参数的相关性。
ARISE 是一项为期约 26 周的前瞻性、非干预性、单臂研究，纳入了起始 IDegAsp 治疗的 2 型糖尿病（T2D）患者。大约 1112 例年龄≥18 岁、既往接受过除 IDegAsp 以外的抗高血糖药物治疗的 T2D 患者将从 2019 年 8 月 15 日至 2020 年 11 月 12 日在六个国家入组。IDegAsp 的起始治疗将由医生根据患者情况决定，并遵循当地的说明书。主要排除标准包括既往参与研究或既往使用过 IDegAsp。主要和次要终点分别为从基线（第 0 周）到研究结束（第 26-36 周）时的 HbA1c 变化和研究结束时达到 HbA1c 目标值<7%的患者比例。混合重复测量模型将用于分析主要终点。
不同国家 2 型糖尿病患者中降糖药物的处方模式存在差异，因此需要在不同的地理环境下检查其临床应用。ARISE 研究旨在评估六个不同国家 IDegAsp 的临床应用，其结果将通过在参与国家建立 IDegAsp 使用的真实世界证据来补充之前的随机对照研究结果。
ClinicalTrials.gov，NCT04042441。于 2014 年 8 月 2 日注册，https://clinicaltrials.gov/ct2/show/NCT04042441。
