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

Abstract

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 Clinicaltrials.gov number NCT03703869. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01266-4.

Real‐world effectiveness and safety of insulin glargine 300 U/ml in insulin‐naïve people with type 2 diabetes in the Latin America region: A subgroup analysis of the ATOS

“…Body weight remained stable throughout the study period in the LATAM participants; this finding is in line with previous global ATOS 23 and Toujeo-1 26 real-world studies. Nevertheless, this contrasts with the REACH trial 20 ($1.1 kg increase) and the EDITION 3 and BRIGHT RCTs, 15,19 which showed weight increases at 6 months following initiation of Gla-300 therapy ($0.5 and 2.0 kg, respectively).…”

“…The results of this subgroup analysis support the findings reported by other studies on Gla‐300 use in insulin‐naïve people with T2D, namely, the global ATOS, 23 DELIVER Naïve, 24 DELIVER Naïve‐D, 25 Toujeo‐1 26 and REACH 20 real‐world studies, and RCTs such as EDITION 3 15 and BRIGHT 19 . The primary outcome of HbA1c target achievement at month 6 in the current subgroup analysis (25.8%) was similar or slightly higher than that in the global ATOS 23 (25.2%), DELIVER Naïve 24 (25.0%) or DELIVER Naïve‐D 25 (23.8%). However, target achievement at month 6 was lower than that observed in Toujeo‐1 26 (33.4%) and REACH 20 (29%), or in RCTs such as EDITION 3 15 (43.1%) and BRIGHT 19 (48.7%).…”

“…In this subgroup analysis, the HbA1c reductions observed at months 6 and 12 were lower than those observed in the global ATOS 23 (the LS mean changes were −0.91% and −1.07% in ATOS LATAM vs. −1.50% and −1.87% in the global ATOS). This could be because of the higher baseline HbA1c (9.4% vs. 9.28%) and lower mean insulin doses at 6 months (20.3 vs. 21.8 U) and at 12 months (21.2 vs. 23.3 U).…”

ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation

“…Таким образом, доза инсулина была всего 0,3 ± 0,1 ЕД/кг массы тела. Во всей когорте пациентов исследования ATOS (по всем странам) результаты оказались сопоставимыми: стартовая доза Гла-300 -14,6 ± 6,5 ЕД/день, через и 12 месяцев дозы инсулина возрастали до 21,8 ± 9,5 и 23,3 ± 10,3 ЕД соответственно [11]. Похожие результаты были получены и в других исследованиях по применению аналогов инсулина в реальной клинической практике -и Гла-300, и Гла-100 [10,12,13].…”

“…В проведенном исследовании динамика массы тела была незначительной и к 12му месяцу терапии составила в среднем -0,4 кг (95% ДИ -0,6 --0,1), что клинически незначимо. Во всей когорте пациентов исследования ATOS результаты были сходными: динамика массы тела равнялась -0,0 (95% ДИ -0,1 -0,1) и -0,1 кг (95% ДИ -0,3 --0,0) через 6 и 12 месяцев соответственно [11].…”