Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes: Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial

Julio Rosenstock (Lead / Corresponding author), Rifat Emral, Leobardo Sauque-Reyna, Viswanathan Mohan, Carlos Trescolí, Saud Al Sifri, Nebojsa Lalic, Agustina Alvarez, Pascaline Picard, Mireille Bonnemaire, Nacima Demil, Rory J. McCrimmon,

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    13 Citations (Scopus)
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    Abstract

    Objective: To directly compare the efficacy and safety of a fixed-ratio combination, iGlarLixi, with a premix insulin analog (BIAsp 30) as treatment advancement in type 2 diabetes suboptimally controlled on basal insulin plus oral antihyperglycemic drugs (OADs).

    Research Design and Methods: SoliMix, a 26-week, open-label, multicenter study, randomized adults with suboptimally controlled basal insulin-treated type 2 diabetes (HbA1c ≥7.5 % and ≤10 %) to once-daily iGlarLixi or twice-daily BIAsp 30. Primary efficacy endpoints were non-inferiority in HbA1c reduction (margin 0.3 %) or superiority in bodyweight change for iGlarLixi versus BIAsp 30.

    Results: Both primary efficacy endpoints were met: after 26 weeks, baseline HbA1c (8.6 %) was reduced by 1.3 % with iGlarLixi and 1.1 % with BIAsp 30, meeting non-inferiority (least squares [LS] mean difference [97.5% CI]: -0.2 [-0.4, -0.1] %; p<0.001). iGlarLixi was also superior to BIAsp 30 for bodyweight change (LS mean difference [95% CI] -1.9 [-2.3, -1.4] kg) and percentage of participants achieving HbA1c <7 % without weight gain and HbA1c <7 % without weight gain and without hypoglycemia (all p<0.001). iGlarLixi was also superior versus BIAsp 30 for HbA1c reduction (p<0.001). Incidence and rates of ADA Level 1 and 2 hypoglycemia were lower with iGlarLixi versus BIAsp 30.

    Conclusions: Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia than twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 in suboptimally controlled type 2 diabetes requiring treatment beyond basal insulin plus OAD therapy.
    Original languageEnglish
    Pages (from-to)2361-2370
    Number of pages10
    JournalDiabetes Care
    Volume44
    Issue number10
    DOIs
    Publication statusPublished - Oct 2021

    Keywords

    • Premix insulin
    • basal insulins
    • Type 2
    • glycemic control
    • GLP-1 agonist
    • hypoglycemia
    • bodyweight
    • therapy
    • therapy intensification
    • GLP-1 RA
    • fixed-ratio combination

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