Introduction & Objective: iGlarLixi is a once-daily injectable fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide. This sub-analysis of Soli-SWITCH (EudraCT number 2021-003711-25) assessed the efficacy and safety of switching from BID administration to once-daily iGlarLixi in people with T2D.
Methods: In this phase 4, 24-week, single-arm study, participants switched from PI to iGlarLixi at baseline. Key inclusion criteria included participants aged ≥18 years who had been diagnosed with T2D for ≥6 months and had received PI for ≥3 months and <10 years. In this sub-analysis we assessed the change in HbA1c (baseline to Week 24) in participants with previous BID PI dosing. The analyses also included the proportion of participants achieving HbA1c <7% at Week 24 and safety.
Results: Overall, 162 participants received iGlarLixi (88.3% BID PI dosing). In the overall population, mean PI dose at baseline was 39.5 units (U) (standard deviation [SD] 13.4), mean iGlarLixi dose at Week 24 was 40.6 U (SD 13.3). In evaluable participants with BID PI dosing at baseline and at Week 24 (n=126), mean HbA1c reduced from baseline to Week 24 by 1.2% (standard deviation [SD] 0.9%); similarly, in the total population, mean HbA1c reduced from baseline to Week 24 (n=145) by 1.2% ([SD] 0.9%). At Week 24, 36.2% of participants with prior BID PI dosing and 37.6% of participants in the total population achieved a HbA1c target of <7%. Confirmed symptomatic hypoglycemia occurred in 38.3% of all participants (ADA level 1: 35.8%; ADA level 2: 15.4%; ADA level 3: 0.0%). No new safety signals were observed in overall population.
Conclusion: iGlarLixi demonstrated improved glycemic outcomes in participants switching to iGlarLixi from BID PI dosing. These data suggest that iGlarLixi may be a potentially simplified treatment alternative for people with T2D currently receiving two daily injections of PIs.
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. K. Min: None. K. Cypryk: Research Support; Novo Nordisk, Sanofi. Speaker's Bureau; Novo Nordisk, Eli Lilly and Company, Sanofi, Merck & Co., Inc. A. Alvarez: Employee; Sanofi. Stock/Shareholder; Sanofi. F. Lauand: Employee; Sanofi. Stock/Shareholder; Sanofi. Y. Ren: Consultant; Sanofi. Employee; Aixial. O. Bakiner: None.
Sanofi
