Rationale and methodology for a European pooled analysis of postmarketing interventional and observational studies of insulin glargine 300 U/mL in diabetes: protocol of REALI project.

Type 2 diabetes mellitus (T2DM) is a common and heterogeneous disease. Using advanced analytic approaches to explore real-world data may identify different disease characteristics, responses to treatment and progression patterns. Insulin glargine 300 units/mL (Gla-300) is a second-generation basal insulin analogue with preserved glucose-lowering efficacy but reduced risk of hypoglycaemia. The purpose of the REALI pooled analysis described in this paper is to advance the understanding of the effectiveness and real-world safety of Gla-300 based on a large European patient database of postmarketing interventional and observational studies. In the current round of pooling, REALI will include data from up to 10 000 subjects with diabetes mellitus (mostly T2DM) from 20 European countries. Outcomes of interest include change from baseline to week 24 in haemoglobin A The proposed study does not involve collection of primary data. Moreover, all individual study protocols were approved by independent local ethics committees, and all study participants provided written informed consent. Furthermore, patient data is deidentified before inclusion in the REALI database. Hence, there is no requirement for ethical approval. Results will be disseminated via peer-reviewed publications and presentations at international congresses as data are analysed.

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: NF: research, travel or consultancy: Takeda, Pfizer, Biogen, Tesaro, Allergan, Ipsen, Sanofi and AstraZeneca. RCB: speakers’ bureau: Sanofi, Merck, Sharp & Dohme, Bristol-Myers Squibb, AstraZeneca and Janssen; Advisory panel: Merck, Sharp & Dohme, Eli Lilly, Sanofi and Johnson & Johnson. PG: research: AstraZeneca, Novo Nordisk and Sanofi; speakers' bureau and consultancy: Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi, Servier and Takeda. DM: consultancy and/or speakers’ bureau: Almirall, Ascensia, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Eli Lilly, Ferrer, Janssen, Menarini, Merck, Sharp & Dohme, Novartis, Novo Nordisk and Sanofi. DMW: speakers’ bureau and consultancy/advisory panel: Amgen, AstraZeneca, Boehringer Ingelheim, MSD (Merck & Co.), Novartis, Novo Nordisk and Sanofi. GB: IVIDATA employee on behalf of Sanofi. CM: IDDI employee. MR: Quinten employee. AC and MB: Sanofi employees.