Abstract
PurposeIDegAsp, 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.MethodsARISE 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 HbA1c from baseline (wk 0) to study end (wk 26–36) and the proportion of patients achieving the target HbA1c level of <7% at the study end, respectively. A mixed model for repeated measurements will analyse the primary endpoint.ConclusionBetween-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.Trial registrationClinicalTrials.gov, NCT04042441. Registered 02 August 2014, https://clinicaltrials.gov/ct2/show/NCT04042441
Highlights
Type 2 diabetes (T2D) is a progressive disease characterised by insulin resistance and deterioration of beta-cell function over time
In patients with T2D who failed to achieve target glycaemic control with oral anti-diabetes drugs (OADs), the addition of basal or prandial insulin regimen led to overall similar reductions in HbA1c, but patients using basal insulin regimens achieved target glycaemic control with fewer hypoglycaemic episodes and less body weight gain than those using other insulin regimens [4]
Male and female patients aged ≥18 years initiated on IDegAsp treatment will be eligible to be enroled in the study if they were diagnosed with T2D and treated with any anti-hyperglycaemic agent in the past 26 weeks and had HbA1c level measured ≤12 wk prior to participation
Summary
Type 2 diabetes (T2D) is a progressive disease characterised by insulin resistance and deterioration of beta-cell function over time. IDegAsp effectively improved glycaemic control and overcame most of the limitations associated with the use of pre-mix or basal-bolus insulin regimens and demonstrated a simpler titration regimen [7,8,9,10,11]. In a 38wk step-by-step intensification trial in patients with T2D, IDegAsp achieved similar efficacy and significantly fewer nocturnal hypoglycaemic episodes but with a significantly lower insulin dose and fewer injections than insulin glargine U100 and insulin aspart administered as a basal-bolus regimen (see Additional file 1) [12]. We present the rationale and design of the ARISE study that aims to assess glycaemic control and other clinical parameters associated with the use of IDegAsp in patients with T2D who were initiated with IDegAsp treatment in real-world settings across six countries, complementing the findings of RCTs on IDegAsp
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
