How many people with type 2 diabetes fulfil the eligibility criteria for randomized, controlled trials of insulin glargine 300 U/mL in a real-world setting?
Mauricio Puente, Dídac (Institut d'Investigació Biomèdica Sant Pau)
Westerbacka, Jukka (Sanofi)
Nicholls, C. (Sanofi)
Wu, Jasmanda (Sanofi)
Gupta, R. (Accenture)
Eliasson, B. (Department of Medicine. University of Gothenburg. Sahlgrenska University Hospital)

Date:	2021
Abstract:	Randomized controlled trial (RCT) populations often do not reflect those typically seen in clinical practice. This retrospective, observational cohort study analysed the real-world data of people with type 2 diabetes (T2DM) prescribed basal insulin analogues from electronic medical records (EMRs) in the Explorys database, which includes data from 39 integrated healthcare systems in the United States, to determine how representative selected RCTs investigating insulin glargine 300 U/mL (Gla-300) are of T2DM populations in a real-world setting. Applying eligibility criteria derived from the EDITION 1, 2 and 3 (Gla-300 vs. insulin glargine 100 U/mL [Gla-100]) and BRIGHT (Gla-300 vs. insulin degludec) RCTs, we observed that only 17% (33 345/191 218) of people captured in the real-world database would have been eligible for such trials. Those who were ineligible tended to be older, had more comorbidities and a higher baseline hypoglycaemia rate than the eligible group. Using another large US EMR database (Optum Humedica) as corroboration, we found that 15% (36 285/235 697) would have been eligible to participate in the EDITION/BRIGHT RCTs. Furthermore, only 7% (1734/24 547) would have been eligible for the CONCLUDE (insulin degludec vs. Gla-300) RCT. Our findings remind us of the value of real-world data studies, complementing the results of RCTs, and providing additional insights into groups who would typically be excluded from RCTs.
Note:	Altres ajuts: Sanofi
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cohort study ; Database research ; Type 2 diabetes ; Basal insulin ; Randomized trial
Published in:	Diabetes, Obesity and Metabolism, Vol. 23 Núm. 3 (march 2021) , p. 838-843, ISSN 1463-1326

DOI: 10.1111/dom.14264
PMID: 33236461

6 p, 716.7 KB

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