Effectiveness and Safety of Insulin Glargine 300 U/ml in High-Risk Subgroups (Renal Impairment and Older Age ≥ 70 years) of Insulin-Naïve People with Type 2 Diabetes: A Post hoc Analysis of Real-World ATOS Study

Introduction: This post hoc analysis of an A Toujeo^® Observational Study (ATOS) aims to evaluate the real-world effectiveness and safety of insulin glargine 300 U/ml (Gla-300) in high-risk subgroups of insulin-naïve people with type 2 diabetes (PwT2D) from multiple geographical regions (Asia, the Middle East, North Africa, Latin America, and Eastern Europe). Methods: In these post hoc analyses of ATOS, a real-world, 12-month, prospective study included 4422 insulin-naïve adults (age ≥ 18 years) with type 2 diabetes (T2D) uncontrolled (HbA_1c > 7% and ≤ 11%) on one or more oral antidiabetic drugs (OADs) who initiated Gla-300 treatment as per routine practice. Primary and secondary endpoints were studied according to renal impairment (RI) status (without or with) and age group (</≥ 70 years). Results: At baseline, participants with a history of RI (N = 581, 13.1%) and older participants (aged ≥ 70 years, N = 514, 11.6%) had a longer duration of diabetes and were more likely to present diabetic complications compared to without RI and younger participants (aged < 70 years). At month 6, the individualized HbA_1c target (as determined by their treating physician) was achieved in 27.5% of participants with RI compared to 24.8% of participants without RI whereas 32.3% of older participants achieved their individualized HbA_1c target compared to 24.2% of younger participants. In this post hoc analysis, Gla-300 treatment improved glycemic control with meaningful reductions in HbA_1c, fasting plasma glucose (FPG) and fasting self-monitored blood glucose (SMBG) across all subgroups. The incidence of hypoglycemia was low and changes in body weight were minimal across all subgroups. Conclusions: In a real-world setting, the initiation of Gla-300 in insulin-naïve PwT2D uncontrolled on OADs resulted in improved glycemic control with a low incidence of hypoglycemia and minimal weight change in participants with a history of RI and in older participants. Trial Registration: Clinicaltrials.gov number NCT03703869.