Real-World Effectiveness and Safety of Insulin Glargine 300 U/mL in Insulin-Naïve People with Type 2 Diabetes: the ATOS Study

Gagik R. Galstyan, Amir Tirosh, Hernando Vargas-Uricoechea, Maria Aileen Mabunay, Mathieu Coudert, Mubarak Naqvi, Valerie Pilorget, Niaz Khan

Research output: Contribution to journalArticlepeer-review


Introduction: The clinical benefits of insulin glargine 300 U/mL (Gla-300) have been confirmed in randomised clinical trials (EDITION programme and BRIGHT) and real-world studies in the USA and Western Europe. ATOS evaluated the real-world effectiveness and safety of Gla-300 in wider geographic regions (Asia, the Middle East, North Africa, Latin America and Eastern Europe). Methods: This prospective observational, international study enrolled adults (≥ 18 years) with type 2 diabetes mellitus (T2DM) uncontrolled [haemoglobin A1c (HbA1c) > 7% to ≤ 11%] on one or more oral anti-hyperglycaemic drugs (OADs) who had been advised by their treating physician to add Gla-300 to their existing treatment. The primary endpoint was achievement of a pre-defined individualised HbA1c target at month 6. Results: Of the 4550 participants included, 4422 (51.8% female) were eligible for assessment. The mean ± standard deviation (SD) age was 57.2 ± 10.8 years, duration of diabetes was 10.2 ± 6.2 years and baseline HbA1c was 9.28 ± 1.0%. The proportion of participants reaching their individualised glycaemic target was 25.2% [95% confidence interval (CI) 23.8–26.6%] at month 6 and 44.5% (95% CI 42.9–46.1%) at month 12. At months 6 and 12, reductions were observed in HbA1c (−1.50% and −1.87%) and fasting plasma glucose (−3.42 and −3.94 mmol/L). Hypoglycaemia incidence was low, and body weight change was minimal. Adverse events were reported in 283 (6.4%) participants, with 57 (1.3%) experiencing serious adverse events. Conclusion: In a real-world setting, initiation of Gla-300 in people with T2DM uncontrolled on OADs resulted in improved glycaemic control and low rates of hypoglycaemia with minimal weight change. Trial Registration: number NCT03703869.

Original languageEnglish
Pages (from-to)1187-1202
Number of pages16
JournalDiabetes Therapy
Issue number6
StatePublished - Jun 2022


  • Basal insulin
  • Glycaemic control
  • Hypoglycaemia
  • Insulin glargine 300 U/mL
  • Real-world
  • Type 2 diabetes


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