1869-LB: Efficacy and Safety of iGlarLixi vs. IDegAsp in Chinese People with Type 2 Diabetes (T2D) Suboptimally Controlled with Oral Antidiabetic Drug(s) (OAD)—The SoliD Randomized Controlled Trial

Introduction and Objective: SoliD (NCT05413369) compared the efficacy and safety of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide, vs insulin degludec + insulin aspart (IDegAsp) in Chinese people with T2D suboptimally controlled with OAD(s).

Methods: In this 24-week, multicenter, open-label, Phase 3 study, insulin-naïve people with HbA_1c 7-11% were randomized 1:1 to once-daily iGlarLixi (n=291) or IDegAsp (n=291), with continued metformin ± sodium-glucose co-transporter-2 inhibitors. The primary endpoint was noninferiority in HbA_1c change from baseline to Week 24. Secondary endpoints included superiority for HbA_1c change, body weight (BW) change, proportion of people with HbA_1c <7.0% at Week 24, composite endpoints, and hypoglycemia rates.

Results: At Week 24, iGlarLixi demonstrated noninferiority, with least squares (LS) mean difference −0.20 (95% confidence interval [CI]: −0.33, −0.07; p<0.001) and superiority (97.5% CI: −0.35, −0.05; p=0.003) vs IDegAsp in HbA_1c reduction. iGlarLixi resulted in a decrease in BW and IDegAsp resulted in an increase in BW from baseline to Week 24, with a LS mean difference of −1.49 kg (97.5% CI: −2.32, −0.66; p<0.001). Other secondary endpoints at Week 24 also favored iGlarLixi vs IDegAsp, respectively (p<0.001 for all): HbA_1c <7.0% (72.5% vs 59.8%); HbA_1c <7.0% + no BW gain (40.5% vs 21.3%); HbA_1c <7.0% + no BW gain + no hypoglycemic events (26.5% vs 13.4%). Event rates (per-person-year) for American Diabetes Association (ADA) Level 1, 2 or 3 hypoglycemia were lower for iGlarLixi (1.90) vs IDegAsp (2.72) (relative risk: 0.71; 95% CI: 0.52, 0.98). No ADA Level 3 hypoglycemia or unexpected safety findings were reported.

Conclusion: In Chinese people with T2D, suboptimally controlled on OAD(s), iGlarLixi achieved superior improvements in glycemic control, prevention of BW gain and a lower hypoglycemic event rate vs IDegAsp.