Efficacy and safety of fixed combination insulin glargine 100 u/ml and lixisenatide in patients with type 2 diabetes mellitus depending on age and baseline HbA1C in the SOLO study

Background. The efficacy and safety of the fixed combination of insulin glargine 100 U/ml and lixisenatide for the treatment of patients with type 2 diabetes mellitus (DM2) have been demonstrated in a number of randomized clinical trials, including the SOLO study, a retrospective cohort study conducted on the territory of the Russian Federation (Moscow). Objective. Evaluation of the efficacy and safety of the fixed combination of glargine 100 and lixisenatide in certain categories of diabetic patients who participated in the SOLO retrospective cohort study, depending on the age of the patients and the initial glycated hemoglobin (HbA1c) level. Methods. SOLO was a retrospective cohort study that included 383 adult DM2 patients with HbA1c levels /7% before starting iGlarLixi, with available retrospective medical information for the period 6 months before the start of therapy with iGlarLixi and 6-12 months after. In this study, the analysis was carried out in groups of patients with different HbA1c levels before use of iGlarLixi (7-<8%, 8-<9%, /9%) and different age groups (<65 and /65 years). Results. The use of iGlarLixi in all analyzed subgroups of patients (with different HbA1c levels and aged <65 and /65 years) led to a decrease in fasting plasma glucose (FPG) and HbA1c after 6 and 12 months. After 12 months, the decrease in HbA1c levels was -0.86%, -1.33 and-2.26%, FPG -1.52mmol/L, -1.95 and -3.09 mmol/L in groups with baseline HbA1c 7<8%, 8<9%, /9%, respectively. After 12 months, the decrease in HbA1c in the group of patients <65 years was -1.76%, in the group /65 years - 1.68%; decrease in FPG -2.4, -2.68 mmol/l, respectively. In all analyzed cohorts of patients, a statistically significant decrease in body weight from baseline values was noted. The use of iGlarLixi was accompanied by a low risk of any hypoglycemia, incl. severe ones. Conclusion. In real outpatient practice, the use of a fixed combination of glargine 100 U/ml and lixisenatide in DM2 patients in groups with different HbA1c levels and age (<65 and /65 years) led to an improvement in glycemic control without increasing body weight and the number of hypoglycemic conditions.

fixed combination of glargine 100 U/ml and lixisenatide, type 2 diabetes mellitus, glargine, lixisenatide