Introduction and Objective: The Soli-SWITCH study assessed the efficacy and safety of switching to iGlarLixi, an injectable fixed-ratio combination therapy of insulin glargine 100 U/mL + lixisenatide, in people with T2DM uncontrolled on premix insulin in a clinical trial setting. The aim of the study is to assess the efficacy and safety of such transition of regimen in a real world setting.Methods: Patients with T2DM who switched from premix insulin regimen to iGlarLixi in Taipei Veterans General Hospital from July 2020 to February 2023 were enrolled. FPG and HbA1c were assessed at baseline, three and six months following transition. HOMA-IR was also calculated. Demographic information and other diabetes-related biochemical indices were collected.Results: A total of 42 patients with a mean age of 68.9 ± 10.8 years switched from premix insulin regimen to iGlarLixi. The baseline FPG was 159.0 ± 58.1 mg/dL, HbA1c was 8.5 ± 2.0% on premix insulin dose of 43.1 ± 21.8 units. After 6 months, HbA1c was 7.86±1.61%, with 29.7% achieving HbA1c <7.0%. Injection frequency decreased from 2.1±0.5 to 1.3±0.7 times (p<0.001) and total insulin dose lowered from 43.9±22.2 to 25.4±16.9 units (p<0.001). Among them, 31.0% (n=13) changed regimen due to hypoglycemia and 69.0% (n=29) switched due to uncontrolled hyperglycemia, defined as a HbA1c ≥7.5%. For the group with HbA1c ≥7.5%, a significant reduction in HbA1c was observed at 6 months (9.4±1.5% to 8.3±1.6%, p=0.01). Patients with total daily dose of 40-50 units of premix insulin experienced the greatest HbA1c reduction, from 10.0±1.8% to 8.3±1.4% (p = 0.037). A multivariate logistic regression considering age, gender, diabetes duration, premix total daily dose, and HOMA-IR identified HOMA-IR as a significant factor (p = 0.049) for achieving HbA1c < 7.5% at 6 months.Conclusion: Switching from premix insulin to iGlarLixi in patients with T2DM serve as a safe and effective approach to simplify treatment complexity and improve glycemic control.
C. Huang: None. S. Yang: None. H. Chen: None.
National Science and Technology Council, R.O.C (NSTC 112-2314-B-075 -025 -)
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