ARISE—a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: rationale and design

Abstract

Purpose 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. Methods 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 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. Conclusion 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. Trial registration ClinicalTrials.gov, NCT04042441. Registered 02 August 2014, https://clinicaltrials.gov/ct2/show/NCT04042441

Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries

“…The study design has been published previously [ 15 ]. Briefly, this was a 26-week, multicentre, prospective, open-label, non-interventional study investigating clinical outcomes in people with T2D after initiating or switching to IDegAsp as per the local label at the discretion of their treating physician (ClinicalTrials.gov, NCT04042441).…”

Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes in Malaysia: Results from a Prospective, Non-Interventional Real-World Study

“…Statistical basis for determining the number of enrolled patients for the ARISE study has been described previously. 9 The primary endpoint was analyzed via adjusted mixed models for repeated measurements (MMRM). This analysis was conducted using an 'in-study' observation period that included all patients in the FAS with at least one post-baseline HbA1c measurement regardless whether they discontinued IDegAsp or not.…”

“…The detailed study design has already been published. 9 Briefly, it was an open-label, 26-week multicenter, prospective, non-interventional study conducted from August 2019 through December 2020 in patients with T2DM. Data were collected from 14 sites in Malaysia.…”

“…8 Treatment with IDegAsp is convenient as it requires minimal injections without resuspension and facilitates accurate dosing. 9 Multiple randomized controlled trials (RCTs) have shown the efficacy and safety of IDegAsp, 6,10 as seen in the BOOST clinical trial program. [11][12][13][14] A post hoc pooled investigation of five phase 3, open-label, treat-to-target, 26-week RCTs comparing twice-daily (BID) IDegAsp with premixed insulin BID regimen or IDeg OD +IAsp confirmed the safety and efficacy of IDegAsp in a broad patient population with varying characteristics.…”

“…India, Saudi Arabia, Australia and the Philippines who were either initiated or switched to IDegAsp. 9 We present the results from the Malaysian cohort from a subgroup analysis of the ARISE study.…”