ATOS, a prospective, 12-month observational study in 18 countries outside US and Western Europe, showed that initiation of Gla-300 in people with T2DM resulted in improved glycemic control with low rates of hypoglycemia and minimal weight change. Here we present the results from a subgroup analysis in participants with (N=581) or without (N=3841) a history of RI (~70% microalbuminuria, Table). Patients with RI were older (62.2±10.3 vs. 56.4±10.7 years), had a longer duration of T2DM (mean: 12.7±6.9 vs. 9.8±6.0 years) and more comorbidities than patients without RI. Baseline HbA1c was comparable between groups (9.3%). Physician-set individualized HbA1c (%) goals at baseline in the RI vs. non-RI groups were <7: 7.2 vs. 14.6%; 7-<7.5: 60.4 vs. 72.0%; 7.5-<8: 25.0 vs. 9.8%; ≥8: 7.4 vs. 3.6%. HbA1c target achievement at Month 6 was 27.5% (95% CI: 23.7-31.6) in RI group and 24.8% (95% CI: 23.4-26.3) in the non-RI group. There was no difference between groups in HbA1c reductions from baseline to Month 6 (-1.50 vs. -1.50%) and 12 (-1.84 vs. -1.88%). The reported hypoglycemia incidence was low although higher in the RI group (Table). Incidence of treatment-emergent adverse events was low in both RI (9.8%) and non-RI (5.9%) groups. Initiation of Gla-300 is effective with low risk of hypoglycemia in T2DM patients with and without RI.
A. Tirosh: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; Self; DreaMed Diabetes, Ltd. N. Khan: None. H. Vargas-uricoechea: Advisory Panel; Spouse/Partner; Sanofi. M. N. Mabunay: Employee; Self; Sanofi, Stock/Shareholder; Self; Sanofi. M. Coudert: Employee; Self; Sanofi. V. Pilorget: Employee; Self; Sanofi. G. R. Galstyan: None.