Efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes: The Soli‐SWITCH study

Abstract Aims To assess the efficacy and safety of switching from premixed insulin to a once‐daily, fixed‐ratio combination of insulin glargine 100 U/mL + lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D). Methods In this phase 4, 24‐week, single‐arm study, participants switched from once‐daily or twice‐daily premixed insulin to iGlarLixi (EudraCT number 2021–003711‐25). Key inclusion criteria: ≥18 years; premixed insulin therapy for ≥3 months and < 10 years; ± 1–2 oral antidiabetic drugs (OADs); HbA1c ≥7.5% to ≤10.0%. The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included: participants achieving HbA1c <7% and change in body weight at Week 24, and safety. Results Overall, 162 participants switched to iGlarLixi (89.5% from twice‐daily premixed insulin); mean duration of diabetes was 15.7 (standard deviation [SD]: 8.3) years. Mean baseline HbA1c (8.5%) reduced by least squares (LS) mean of 1.2% (95% confidence interval [CI]: −1.4, −1.1) at Week 24, and 37.6% of participants had achieved an HbA1c target of <7% (95% CI: 30.0, 45.7). LS mean body weight change from baseline to Week 24 was −1.0 kg (95% CI: −1.6, −0.5). Fasting and post‐prandial plasma glucose decreased from baseline to Week 24 by 45.6 mg/dL (SD ± 52.4) and 67.6 mg/dL (SD ± 65.1), respectively. Confirmed symptomatic hypoglycaemia occurred in 38.3% of participants (ADA level 1: 35.8%; level 2: 15.4%; level 3: 0.0%). Conclusions iGlarLixi initiation was associated with improved glycaemic control, without body weight gain or increased hypoglycaemia over 24 weeks.