Findings for iGlarLixi vs BIAsp 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics

Philip D. Home (Lead / Corresponding author), Rory J. McCrimmon, Julio Rosenstock, Matthias Blüher, Katrin Pegelow, Lydie Melas-Melt, Khier Djaballah, Francesco Giorgino,

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background: The SoliMix study reported improved HbA1c with weight benefit and less hypoglycaemia with iGlarLixi versus BIAsp 30 in adults with suboptimally controlled type 2 diabetes using basal insulin. Here we report pre-specified and post hoc analyses of the SoliMix dataset exploring the impact of baseline participant characteristics on the original SoliMix study outcomes, to enable informed treatment choices for people with different biomedical characteristics.

    Methods: SoliMix (EudraCT 2017-003370-13) compared once-daily iGlarLixi (a fixed-ratio combination of insulin glargine 100 U/mL and the GLP-1 receptor agonist lixisenatide) with twice-daily BIAsp 30 (30% insulin aspart and 70% insulin aspart protamine). In this analysis, the original primary outcomes of non-inferiority of iGlarLixi versus BIAsp 30 in HbA1c change and superiority in body weight change, together with change in basal insulin dose and hypoglycaemia outcomes, were investigated by baseline age, duration of diabetes, insulin dose, HbA1c, BMI, and renal function.

    Results: No evidence of difference in comparative treatment effect was detected across baseline age, duration of diabetes, insulin dose, HbA1c, BMI, and renal function subgroups for any endpoint (all heterogeneity p>0.05), except ADA Level 2 hypoglycaemia event rate when stratified by insulin dose (p=0.011), which may be a chance difference given multiple testing and the small numbers of Level 2 events.

    Conclusions: Treatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes, and renal function, supporting the use of iGlarLixi as an efficacious and well-tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics.
    Original languageEnglish
    JournalDiabetes, Obesity & Metabolism
    Early online date30 Oct 2022
    DOIs
    Publication statusE-pub ahead of print - 30 Oct 2022

    Keywords

    • iGlarLixi
    • GLP-1 analogue
    • basal insulin
    • insulin therapy
    • type 2 diabetes
    • glycaemic control
    • randomized trial
    • hypoglycaemia

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