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Randomized Controlled Trial
. 2020 Apr;36(4):571-581.
doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

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

Nick Freemantle  1 , Didac Mauricio  2 , Andrea Giaccari  3 , Timothy Bailey  4 , Ronan Roussel  5   6   7 , Denise Franco  8 , Baptiste Berthou  9 , Valerie Pilorget  10 , Jukka Westerbacka  11 , Zsolt Bosnyak  11 , Mireille Bonnemaire  11 , Anna M G Cali  11 , My-Liên Nguyên-Pascal  10 , Alfred Penfornis  12 , Manuel Perez-Maraver  13 , Jochen Seufert  14 , Sean D Sullivan  15 , John Wilding  16 , Carol Wysham  17 , Melanie Davies  18
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Free article
Randomized Controlled Trial

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

Nick Freemantle et al. Curr Med Res Opin. 2020 Apr.
Free article

Abstract

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.

Keywords: Clinical trial; drug therapy; insulin; type 2 diabetes mellitus.

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