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Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus

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posted on 2020-03-19, 12:30 authored by Nick Freemantle, Didac Mauricio, Andrea Giaccari, Timothy Bailey, Ronan Roussel, Denise Franco, Baptiste Berthou, Valerie Pilorget, Jukka Westerbacka, Zsolt Bosnyak, Mireille Bonnemaire, Anna M. G. Cali, My-Liên Nguyên-Pascal, Alfred Penfornis, Manuel Perez-Maraver, Jochen Seufert, Sean D. Sullivan, John Wilding, Carol Wysham, Melanie Davies
Objective: 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.Methods: In these open-label, parallel-group, pragmatic studies, patients (HbA1c > 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 HbA1c 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.Results: 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 HbA1c 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 HbA1c 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.Conclusions: 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.

History

Citation

Current Medical Research and Opinion, 2020, Article RT-0537.R1/1708287

Author affiliation

Diabetes Research Centre

Version

  • VoR (Version of Record)

Published in

Current Medical Research and Opinion

Publisher

Taylor & Francis

issn

0300-7995

eissn

1473-4877

Acceptance date

2019-12-17

Copyright date

2020

Available date

2020-01-19

Publisher version

https://www.tandfonline.com/doi/full/10.1080/03007995.2019.1708287

Language

en

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