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

Aim To evaluate the real-world effectiveness and safety of insulin glargine 300 U/ml (Gla-300) in achieving glycaemic goals in insulin-naive people with type 2 diabetes (T2D) in Mexico, Colombia and Peru (Latin America region) in the A Toujeo Observational Study (ATOS). Materials and Methods ATOS was a multicentre, prospective, 12-month observational study, which included 4422 insulin-naive adults (age >= 18 years) with T2D uncontrolled (HbA1c > 7% and <= 11%) on at least one oral antidiabetic drug (OAD) who initiated Gla-300 treatment as per routine practice. The primary endpoint was the percentage of participants achieving their predefined individualized HbA1c goal at month 6. Key secondary endpoints included change from baseline in HbA1c, fasting plasma glucose (FPG), fasting self-monitored blood glucose (SMBG), body weight and incidence of hypoglycaemia. Results In this subgroup analysis, a total of 314 participants with T2D received Gla-300. At baseline, mean +/- SD age was 56.0 +/- 11.6 years, duration of diabetes was 9.7 +/- 6.6 years and 65.9% of participants were on at least two OADs. The individualized HbA1c target was achieved by 25.8% of participants (95% confidence interval [CI]: 20.3-31.9) at month 6 and by 35.3% (95% CI: 28.5-42.5) at month 12. Gla-300 treatment improved glycaemic control with meaningful reductions in mean HbA1c, FPG and fasting SMBG. The incidence of hypoglycaemia reported was low and body weight remained stable. Conclusions In a real-world setting in the Latin America region, the initiation of Gla-300 in people with T2D uncontrolled on OADs resulted in improved glycaemic control with a low incidence of hypoglycaemia and no change in body weight.