ATOS is a prospective, 12-month, observational study assessing real-world effectiveness of the second-generation basal insulin analog Gla-300 in emerging markets. Insulin-naïve adults (≥18 years) with T2DM, HbA1c >7-≤11 % and previously treated with ≥1 oral antihyperglycemic drug were recruited in 18 countries. An interim analysis was undertaken when ≥50% of participants had 6-months’ follow-up data (cut-off July 1, 2019); this included 4527 eligible patients (Eastern Europe: 1748; Egypt: 214; India: 1269; Latin America and Caribbean: 317; Western Asia: 882; Southeast Asia: 46; Taiwan: 51). Mean (SD) age was 57.2 (10.8) years, BMI was 29.4 (5.3) kg/m2, and duration of diabetes was 10.2 (6.2) years; 48.4% were male. Physician-set individualized HbA1c (%) goals at baseline were <7: 13.7%; 7-<7.5: 70.3%; 7.5-<8: 11.9%; ≥8: 4.2%. The proportion of evaluable patients achieving HbA1c goal at Month 6 (primary outcome) was 25.1% (95% CI: 23.6 to 26.6); HbA1c decreases are shown in Table. Hypoglycemia incidence was low (<2%). Treatment-emergent adverse events (TEAEs) were reported in 230 (5.0%) patients, with 47 (1.0%) serious TEAEs (included population). ATOS showed high baseline HbA1c, suggesting delayed insulin initiation; introduction of Gla-300 led to marked improvements in HbA1c with a good safety profile in a real-world setting.
G.R. Galstyan: None. A. Bhansali: None. H. Vargas-Uricoechea: Speaker’s Bureau; Self; Sanofi-Aventis. A. Tirosh: Advisory Panel; Self; Novo Nordisk Inc., Sanofi. G. Sun: None. M. Naqvi: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. M. Coudert: Employee; Self; Roche Pharma, Sanofi-Aventis. D. Cherkasov: None. N. Khan: None.
Sanofi (ATOS/NCT03703869)
