Introduction & Objective: iGlarLixi is a once-daily injectable fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide and may be a simplified treatment option vs PI. This sub-analysis of the Soli-SWITCH study (EudraCT number 2021-003711-25) assessed the efficacy and safety of switching to iGlarLixi in people with T2D from South Korea currently receiving once- or twice-daily PI.
Methods: In this phase 4, 24-week, single-arm study, participants switched from PI to iGlarLixi at baseline. Key inclusion criteria: participants aged ≥18 years diagnosed with T2D ≥6 months before the screening visit; had received PI for ≥3 months and <10 years ± oral antidiabetic drugs, with stable doses for 3 months. Participants who experienced severe hypoglycemia within <6 months prior to screening were excluded. The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included the proportion of participants achieving HbA1c <7% at Week 24 and safety.
Results: From 162 participants, 62 (38.3%) evaluable participants were from South Korea and received iGlarLixi. At baseline, mean HbA1c was 8.6%, standard deviation (SD) ± 0.7%. By Week 12, mean HbA1c had decreased by 1.4% (SD ± 0.8; 95% confidence interval [CI]: -1.5, -1.2). At Week 24, mean HbA1c was reduced from baseline by 1.3% (SD ± 1.0; 95% CI: -1.6, -1.1); similarly, in the total population, mean HbA1c reduced from baseline to Week 24 by 1.2% (SD ± 0.9%; 95% CI: -1.4, -1.1). In the overall population, confirmed symptomatic hypoglycemia occurred in 38.3% of total participants (ADA level 1: 35.8%; ADA level 2: 15.4%; ADA level 3: 0.0%). No new safety signals were observed.
Conclusion: In this sub-analysis of Soli-SWITCH, iGlarLixi demonstrated improved glycemic outcomes in South Korean participants living with T2D switching from PI, and may represent a simplified and efficacious treatment option vs PI in people of Asian ethnicity.
S. Lim: None. M. Haluzik: Advisory Panel; Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Johnson & Johnson Medical Devices Companies. Consultant; Merck & Co., Inc., Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Johnson & Johnson Medical Devices Companies, Novatin. Research Support; Sanofi. Speaker's Bureau; Sanofi, Novo Nordisk. J. Yun: None. J. Lee: None. S. Kim: Research Support; Sanofi, Novo Nordisk, Boryung, Hanmi Pharm. Co., Ltd., Handok, Deawoong. Speaker's Bureau; Boryung, Hanmi Pharm. Co., Ltd., Handok, Sanofi, Novo Nordisk. A. Alvarez: Employee; Sanofi. Stock/Shareholder; Sanofi. F. Lauand: Employee; Sanofi. Stock/Shareholder; Sanofi. Y. Ren: Consultant; Sanofi. Employee; Aixial. S. Yoo: None.
Sanofi
