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://ichgcp.net/clinical-trials-registry/NCT04042441.

Keywords: Co-formulation; Insulin aspart; Insulin degludec; Real world; Type 2 diabetes.

Conflict of interest statement

G.R.F. has received honoraria, teaching and research sponsorship/grants from AstraZeneca, Boehringer Ingelheim, Janssen, MSD, Novartis, Novo Nordisk and Sanofi-Aventis. H.J., J.S.P. and L.L. are employees of and hold shares at Novo Nordisk. K.P.S. has no conflicts of interests to disclose. M.M. received research contracts from Novo Nordisk and Eli Lilly and is a member of the local advisory board for Novo Nordisk, Eli Lilly and Sanofi. N.A.N. is a member of the local advisory board of Novo Nordisk, AstraZeneca, Merck and Torrent and received speaker honoraria from Novo Nordisk, AstraZeneca, Merck, Torrent, Eli Lilly, Sanofi, LRI-Therapharma and Servier. S.J.A.-J. has no conflicts of interests to disclose. A.K. has been involved in various advisory boards for Abbott, Adcock Ingram, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, Merck, Merck Sharp & Dohme, Mundipharma, Novartis, Novo Nordisk, Pfizer and Sanofi and is a speaker panel member for Abbott, Aspen–GlaxoSmithKline, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen Pharmaceuticals, Merck, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pharmaplan, Pfizer and Sanofi and is involved in research with AstraZeneca, Merck Sharp & Dohme, Novo Nordisk and Pfizer. A.K. has received speaker or consulting honoraria from Novo Nordisk, Eli Lilly, AstraZeneca, Boehringer Ingelheim, Merck Sharp & Dohme, Sanofi, Amgen, Abbott, GlaxoSmithKline and Servier. A.K. served as a consultant and speaker panel member for Novo Nordisk.

© 2021. The Author(s).

Figures

Fig. 1

Study design