Background and Aims

The clinical benefits of Insulin glargine 300U/mL (Gla-300), a second-generation basal insulin analog, have been confirmed in real-world studies in the US and Western Europe. However real-world effectiveness and safety of Gla-300 in wider geographic regions is needed. ATOS is a prospective, 12-month, observational study assessing real-world effectiveness and safety of Gla-300 in countries outside US and Western Europe.

Methods

Adults (≥18 years) with T2DM, uncontrolled (HbA_1c >7–≤11%) on ≥1 oral antihyperglycaemic drug (OAD) in whom the treating physician had decided to add Gla-300 were recruited from Asia, Middle East and Africa, Eastern Europe and Latin America.

Results

Overall, 4422 participants (51.8% females) were eligible. Mean (SD) age was 57.2 (10.8) years, duration of diabetes was 10.2 (6.2) years and baseline HbA_1c was 9.28 (1.00)%. Physician-set individualized HbA_1c(%) goals at baseline were <7: 13.7%; 7–<7.5: 70.4%; 7.5–<8: 11.8%; ≥8: 4.1%. The proportion of patients achieving their HbA_1c goal at Month 6 (primary endpoint) and Month 12 was 25.2% (95%CI: 23.8-26.6) and 44.5% respectively; HbA_1c reductions from baseline to Month 6 and 12 were -1.50 and -1.87 respectively. The documented hypoglycaemia incidence (<2%) and change in body weight (LSM, -0.1 (95%CI: -0.3-0.0) at Month 12) was low. Treatment-emergent adverse events (TEAEs) were reported in 283 (6.4%) patients, with 57 (1.3%) serious TEAEs.

Conclusions

In a real-life setting in countries outside US and Western Europe, 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.

Data first submitted to AACE-GulfChapter 2020.