Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus
Freemantle, Nick (University College London)
Mauricio Puente, Dídac (Institut d'Investigació Biomèdica Sant Pau)
Giaccari, Andrea (Università Cattolica del Sacro Cuore)
Bailey, Timothy (AMCR Institute)
Roussel, Ronan (UFR de Médecine. Paris University)
Franco, Denise (CPCLIN Clinical Research Center)
Berthou, Baptiste (IT&M Stats)
Pilorget, Valerie (Sanofi)
Westerbacka, Jukka (Sanofi)
Bosnyak, Zsolt (Sanofi)
Bonnemaire, Mireille (Sanofi)
Cali, Anna M.G (Sanofi)
Nguyên-Pascal, My-Liên (Sanofi)
Penfornis, Alfred (Corbeil-Essonnes and Université Paris Sud)
Perez-Maraver, Manuel (Hospital Universitari de Bellvitge)
Seufert, Jochen (University of Freiburg)
Sullivan, Sean D. (University of Washington)
Wilding, John (University of Liverpool)
Wysham, Carol (Multicare Rockwood Clinic)
Davies, Melanie (University of Leicester)
Universitat Autònoma de Barcelona

Fecha:	2020
Resumen:	To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naïve; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil. In these open-label, parallel-group, pragmatic studies, patients (HbA > 7. 0%) were randomized to Gla-300 or SoC BI for a 6-month treatment period (to demonstrate non-inferiority of Gla-300 vs SoC BIs for HbA change [non-inferiority margin 0. 3%]) and a 6-month extension period (continuing with their assigned treatment). Insulin titration/other medication changes were at investigator/patient discretion post-randomization. Overall, 703 patients were randomized to treatment in REACH (Gla-300, n = 352; SoC, n = 351) and 609 (Gla-300, n = 305, SoC, n = 304) in REGAIN. The primary outcome, non-inferiority of Gla-300 versus SoC for HbA change from baseline to month 6, was met in REACH (least squares [LS] mean difference 0. 12% [95% CI -0. 046 to 0. 281]) but not REGAIN (LS mean difference 0. 17% [0. 015-0. 329]); no between-treatment difference in HbA change was shown after 12 months in either study. BI dose increased minimally from baseline to 12 months in REACH (Gla-300, +0. 17 U/kg; SoC, +0. 15 U/kg) and REGAIN (Gla-300, +0. 11 U/kg; SoC, +0. 07 U/kg). Hypoglycemia incidence was low and similar between treatment arms in both studies. In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs were seen over 12 months. However, the suboptimal insulin titration in REACH and REGAIN limits comparisons of outcomes between treatment arms and suggests that more titration instruction/support may be required for patients to fully derive the benefits from newer basal insulin formulations.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Clinical trial ; Drug therapy ; Insulin ; Type 2 diabetes mellitus
Publicado en:	Current Medical Research and Opinion, Vol. 36 Núm. 4 (february 2020) , p. 571-581, ISSN 1473-4877

DOI: 10.1080/03007995.2019.1708287
PMID: 31865758

13 p, 1.6 MB

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