Introduction & Objective: In a 16-week open-label trial (NCT05114590) of insulin naïve adults (≥ 18 yrs; 70.2% Hispanic/Latino) with T2D (mean A1c >10%) suboptimally controlled on ≥2 oral antihyperglycemic drugs (OADs) ± glucagon-like peptide-1 receptor agonist (GLP-1 RA), iGlarLixi increased TIR by 26.2% (P<0.001), as measured by blinded CGM. We report a post-hoc analysis of SU users vs non-SU users.
Methods: We quantified on-treatment hypoglycemia incidence and mean changes in CGM and glucose control endpoints from baseline to Week 16 in SU vs non-SU users (Table).
Results: In total 124 participants were enrolled, 91 (73%) used a background SU (76% self-identified as Hispanic/Latino). Total hypoglycemia incidence was low and similar for SU vs non-SU users with no reported severe events. Nocturnal hypoglycemia was only reported by SU users (Table). Mean improvements in CGM (including TIR) and glucose control endpoints were numerically greater in non-SU vs SU users (Table).
Conclusion: In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RA, iGlarLixi for 16 weeks improved glycemic control. Compared to SU users, non-SU users achieved greater improvements in glucose control without nocturnal hypoglycemia. To safely optimize T2D diabetes management, iGlarLixi may be best prescribed without a concurrent SU.
A. Ratzki-Leewing: Research Support; Sanofi. Advisory Panel; Dexcom, Inc. Consultant; Abbott. Advisory Panel; Sanofi-Aventis U.S. Other Relationship; American Diabetes Association. Consultant; Novo Nordisk, Eli Lilly and Company. T.A. Dex: Stock/Shareholder; Pfizer Inc. Employee; Sanofi. Stock/Shareholder; Viatris Inc., Teva Pharmaceutical Industries Ltd. L. Meneghini: Employee; Sanofi. A. Rodrigues: Consultant; Sanofi. J.P. Frias: Research Support; Akero Therapeutics, Inc. Consultant; Akero Therapeutics, Inc. Research Support; Altimmune Inc. Consultant; Altimmune Inc. Research Support; Boehringer-Ingelheim. Consultant; Boehringer-Ingelheim. Research Support; 89bio, Inc. Consultant; 89bio, Inc. Research Support; Eli Lilly and Company. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Merck & Co., Inc. Consultant; Merck & Co., Inc. Research Support; Novartis Pharmaceuticals Corporation. Consultant; Novartis Pharmaceuticals Corporation, Novo Nordisk. Board Member; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Consultant; Pfizer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Stock/Shareholder; Biomea Fusion, Inc. Employee; Biomea Fusion, Inc.
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