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
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-gener...
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BMJ Publishing Group
2020-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/4/e033659.full |
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| author | Nick Freemantle Didac Mauricio Riccardo C Bonadonna Pierre Gourdy Dirk Mueller-Wieland Gregory Bigot Alice Ciocca Celine Mauquoi Mélissa Rollot Mireille Bonnemaire |
| author_facet | Nick Freemantle Didac Mauricio Riccardo C Bonadonna Pierre Gourdy Dirk Mueller-Wieland Gregory Bigot Alice Ciocca Celine Mauquoi Mélissa Rollot Mireille Bonnemaire |
| author_sort | Nick Freemantle |
| collection | DOAJ |
| description | 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 postmarketing 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 A1c, 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. |
| format | Article |
| id | doaj-art-9cd5a7c486ed441fb0dcc88c31b873a9 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-9cd5a7c486ed441fb0dcc88c31b873a92025-08-20T02:19:54ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-033659Rationale and methodology for a European pooled analysis of postmarketing interventional and observational studies of insulin glargine 300 U/mL in diabetes: protocol of REALI projectNick Freemantle0Didac Mauricio1Riccardo C Bonadonna2Pierre Gourdy3Dirk Mueller-Wieland4Gregory Bigot5Alice Ciocca6Celine Mauquoi7Mélissa Rollot8Mireille Bonnemaire9professor of clinical epidemiology and biostatistics4 Department of Endocrinology & Nutrition, Hospital de la Santa Creu i Sant Pau, Barcelona, SpainAzienda Ospedaliero-Universitaria di Parma, Parma, Emilia-Romagna, ItalyDepartment of Diabetology, metabolic Diseases and Nutrition, CHU de Toulouse, Toulouse, FranceUniversity Hospital Aachen, Aachen, Nordrhein-Westfalen, GermanyIVIDATA, Paris, FranceGlobal Diabetes, Sanofi SA, Paris, Île-de-France, FranceIDDI SA, Louvain-la-Neuve, BelgiumQuinten, Paris, FranceGlobal Diabetes, Sanofi SA, Paris, Île-de-France, FranceIntroduction 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.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 A1c, 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.https://bmjopen.bmj.com/content/10/4/e033659.full |
| spellingShingle | Nick Freemantle Didac Mauricio Riccardo C Bonadonna Pierre Gourdy Dirk Mueller-Wieland Gregory Bigot Alice Ciocca Celine Mauquoi Mélissa Rollot Mireille Bonnemaire 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/4/e033659.full |
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