Dr. Awadhesh Kumar Singh: ATOS Study
ATOS is a 12 month prospective, observational, real-world study conducted in 18 countries outside the United States and Western Europe, including India.
A posthoc analysis of ATOS was carried out to determine the titration patterns for the 6 and 12 month periods for patients who were administered insulin glargine 300 U/mL. The endpoints were analyzed and further categorized into four subgroups.
- Group A: Patients receiving 2 units of insulin for three months
- Group B: Patients receiving 2-6 units of insulin for three months
- Group C: Patients receiving 6-10 units of insulin for three months
- Group D: Patients receiving >10 units of insulin for three months
Primary and Secondary endpoint
The study outcomes were first captured at 6 months to measure the primary outcome, which was calculated as the percentage of participants achieving a predefined, individualized HbA1c goal, and the secondary outcome was measured at 6 and 12 months of the study.
HbA1c target achievement and HbA1c change from baseline
It was interesting to note that patients in group D who were titrated at a higher dose had the greatest drop in HbA1c value compared to other groups. Despite the better HbA1c value, there was a minimal increment in hypoglycemia compared to other groups.
Thus, it suggests that in the real-world clinical setting, Gla-300 was effective in reducing HbA1c, FPG and SMPG levels with low rates of hypoglycemia, regardless of the magnitude of insulin titration. This study highlights that insulin treatment should be individualized and that titration could be further optimized in patients treated for type 2 diabetes. Physicians often struggle to begin the treatment with insulin and titrate it later for fear of hypoglycemia. The significance of the ATOS Study is that hypoglycemia was rarely observed, even if a high dose of 10 units was administered over three months.
In this subgroup analysis of the ATOS study, the titration of Gla-300 in people with T2D is effective in achieving HbA1c goals and improving glycemic control with a low incidence of reported hypoglycaemia.