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 effective-ness 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 target achievement after 6 months was 27.7%. This figure increased to 51.2% after 12 months. In individuals ³65 years, the HbA1c target achievement after 6 and 12 months was 36% and 52%, respectively. The mean HbA1c% reduced from a baseline value of 9.45 (0.94) to 7.36 (0.60) after 6 months and 6.97 (±0.55) after 12 months of Gla-300 treatment. No major or serious adverse events (AEs) were reported during the follow-up period. Two participants (0.9%) had hypoglyc-emic events, with only oneexperiencing severe hypoglycemia. Conclusion: Insulin treatment with Glar-300 in Egyptian individuals with T2D Muncontrolled on OADs improved glycemic control, and target HbA1c level was achieved in 27.7% after 6 months with a very low risk of hypoglycemia and other treatment-related AEs. People with T2DM who are uncontrolled on OADs may benefit from therapy with Gla-300. Our study results are in line with the results of previously conducted studies.