A 12-Month Prospective Observational Study Assessing the Real-World Clinical Effectiveness and Safety of Insulin Glargine 300 U/mLInitiation After Oral Antidiabetic Drug Failure in Insulin-Naïve Individuals with Type 2 Diabetes Mellitus in Egypt: A Posthoc Subgroup Analysis [ATOS Study]

Abstract

Background: Reaching the HbA1c target and keeping the euglycemic state are major challenges in the management of individuals with diabetes. Given the high rate of failure of oral antidiabetic drugs (OADs) to control the glycemic state of individuals with type-2 diabetes mellitus (T2DM), other new options have emerged to replace the traditional treatments in such cases. Second-generation basal insulin glarginehas proven its safety and efficacy in improving glycemic control in individuals with uncontrolled T2DM in multiple randomized clinical trials (RCTs). Aim of Study: This study aims to assess the effectiveness and safety of insulin glargine 300U/mL (Gla-300) when added to OADs and titrated to individualized goals in real-world practice. Patient and Methods: The ATOS study was a prospective, observational, international, multicenter study to collect information on 4422 individuals with T2DMinitiating Gla-300 across 18 countries in different geographical regions, and which routinely assessed glycated hemoglobin (HbA1c) at least every 6 months (NCT03703869). Our posthocsub group analysis is a part of this large-scale multinational study that analyzed the data collected from Egypt, one of the countries representing the South African region, to assess the real-world effectiveness of Gla-300 in Egyptian individuals with T2DM. The primary outcomes include an assessment of the effectiveness of Gla-300 in achieving glycemic goals measured by HbA1c after 6 months. The secondary objectives include effectiveness and safety during the extended follow-up period (12 months). Results: This posthocsubgroup analysis included 216 individuals with T2DM in Egypt with a mean age of 52.7 ( – 9.8) years. The mean body weight and bodymass index (BMI) were 86.8 ( – 13.6) and 30.6 ( – 5.0), respectively. Most included participants were on more than one concomitant OAD (mostly metformin and sulfonylureas). The HbA1c