Introduction & Objective: iGlarLixi, a once-daily injectable fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide, has demonstrated improved glycemic control in people with T2D vs its monocomponents and may be a simplified treatment option vs PI. The Soli-SWITCH study (EudraCT number 2021-003711-25) assessed the efficacy and safety of switching to iGlarLixi in people with T2D currently receiving PI.
Methods: In this phase 4, 24-week, single-arm study, participants switched from PI to iGlarLixi at baseline. Key inclusion criteria: age ≥18 years, diagnosed with T2D, received PI for ≥3 months and <10 years, ± oral antidiabetic drugs; HbA1c ≥7.5% to ≤10.0%. Those who experienced severe hypoglycemia <6 months before screening were excluded. The primary endpoint was change in HbA1c from baseline to Week 24. Key secondary endpoints included the proportion of participants achieving HbA1c <7% at Week 24 and safety.
Results: Overall, 162 participants received iGlarLixi (60% aged ≥65 years; 55% male; 88% PI twice-daily dosing; median duration of diabetes, 16.0 years). 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). Mean baseline HbA1c (8.5%) was reduced by 1.2% (SD 0.9%; 95% confidence interval [CI], -1.4, -1.1) at Week 24. At Week 24, 37.6% participants had achieved a HbA1c target of <7% (95% CI: 30.0, 45.7). Median body weight change from baseline to Week 24 was -0.9 kg (95% CI: -1.5, -0.3). 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 hypoglycemia occurred in 38.3% of participants (ADA level 1: 35.8%; ADA level 2: 15.4%; ADA level 3: 0.0%). No new safety signals were observed.
Conclusion: Switching from PI to iGlarLixi offered a simplified treatment option, with improved glycemic outcomes in people with T2D, with added weight benefits and low hypoglycemia risk.
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. 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. V. Corp dit Genti: Employee; Sanofi. O. Bakiner: None. S. Lim: None.
Sanofi
