Advancing therapy with iGlarLixi versus Premix 70/30 in basal insulin‐treated type 2 diabetes: Design and baseline characteristics of the SoliMix randomised controlled trial

Aims Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulin glargine 100 units/mL (iGlar) and the GLP-1 RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomised controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue (70/30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. Materials and methods This is an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomised to switch to either iGlarLixi once daily, or premix (BiAsp) 70/30 twice daily, for 26 weeks. Results Overall, 887 participants have been enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D ≥10 years, and the mean HbA1c at baseline was 8.6 %. Conclusions The study directly compares efficacy and safety of iGlarLixi versus premix 70/30 in people with T2D uncontrolled on basal insulin and one or more oral agents. These results will provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy. This article is protected by copyright. All rights reserved.