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
Por:
Freemantle, N, Bonadonna, RC, Gourdy, P, Mauricio, D, Mueller-Wieland, D, Bigot, G, Ciocca, A, Mauquoi, C, Rollot, M and Bonnemaire, M
Publicada:
1 abr 2020
Ahead of Print:
28 abr 2020
Resumen:
Introduction 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 post-marketing interventional and observational studies.
Methods and analysis 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(1c), fasting plasma glucose, self-measured plasma glucose, body weight, insulin dose, incidence and rate of any-time-of-the-day and nocturnal hypoglycaemia. The data pool is being investigated using two complementary methodologies: a conventional descriptive, univariate and multivariable prognostic analysis; and a data-mining approach using subgroup discovery to identify phenotypic clusters of patients who are highly associated with the outcome of interest. By mid-2019, deidentified data of 7584 patients were included in the REALI database, with a further expected increase in patient number in 2020 as a result of pooling additional studies.
Ethics and dissemination 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.
Filiaciones:
Freemantle, N:
UCL, Inst Clin Trials & Methodol, London, England
Bonadonna, RC:
Azienda Osped Univ Parma, Parma, Emilia Romagna, Italy
Univ Parma, Sch Med, Parma, Emilia Romagna, Italy
Gourdy, P:
Univ Hosp Ctr Toulouse, Cardiovasc & Metab Med Sect, Toulouse, Midi Pyrenees, France
Paul Sabatier Univ, INSERM, Toulouse, Occitanie, France
:
Hosp Badalona Germans Trias & Pujol, Endocrinol & Nutr, Barcelona, Spain
Hosp Santa Creu & St Pau Inst Recerca, Barcelona, Catalunya, Spain
Mueller-Wieland, D:
Univ Hosp Aachen, Aachen, Nordrhein Westf, Germany
Bigot, G:
IVIDATA, Paris, France
Ciocca, A:
Sanofi SA, Global Diabet, Paris, Ile De France, France
Mauquoi, C:
IDDI SA, Louvain La Neuve, Belgium
Rollot, M:
Quinten, Paris, France
Bonnemaire, M:
Sanofi SA, Global Diabet, Paris, Ile De France, France
Green Published, gold
|