Advancing therapy in people with suboptimally controlled basal insulin‐treated type 2 diabetes: Subanalysis of the SoliMix trial in participants in Latin American countries

Abstract

AbstractAimsThis subanalysis of the SoliMix trial assessed the efficacy and safety of advancing basal insulin (BI) therapy with iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D) living in Latin American (LATAM) countries, i.e. Argentina and Mexico (N = 160).Materials and MethodsSoliMix (EudraCT: 2017‐003370‐13) was a 26‐week, open‐label, multicentre study, where adults with T2D suboptimally controlled with BI plus one or two oral glucose‐lowering drugs and glycated haemoglobin (HbA1c) ≥7.5% to ≤10% were randomized to once‐daily iGlarLixi or twice‐daily BIAsp 30. Primary efficacy endpoints were non‐inferiority in HbA1c reduction (margin 0.3%) or superiority in body weight change for iGlarLixi versus BIAsp 30.ResultsBoth primary efficacy endpoints were met in the LATAM region. After 26 weeks, HbA1c was reduced by 1.8% with iGlarLixi and 1.4% with BIAsp 30, meeting non‐inferiority [least squares mean difference −0.47% (95% confidence interval: −0.82, −0.11); p < .001]. iGlarLixi was superior to BIAsp 30 for body weight change [least squares mean difference −1.27% (95% confidence interval: −2.41, −0.14); p = .028]. iGlarLixi was also superior to BIAsp 30 for HbA1c reduction (p = .010). A greater proportion of participants achieved HbA1c <7% without weight gain and HbA1c <7% without weight gain and without hypoglycaemia with iGlarLixi versus BIAsp 30. Incidence and rates of American Diabetes Association Level 1 and 2 hypoglycaemia were lower with iGlarLixi versus BIAsp 30.ConclusionsOnce‐daily iGlarLixi provided better glycaemic control with weight benefit and less hypoglycaemia than twice‐daily premix BIAsp 30. iGlarLixi may be a favourable alternative to premix BIAsp 30 in people with suboptimally controlled T2D to advance BI therapy in the LATAM region.