Prescription characteristics of the insulin glargine plus lixisenatide fixed-ratio combination in real-world clinical practice according to the Registry of Diabetes Mellitus in the Moscow Region

Background: An individualized approach to the treatment of type 2 diabetes mellitus (T2DM) in real-world clinical practice involves identification of patients groups with a maximal response to a certain type of therapeutic intervention. The assessment of clinical characteristics of T2DM patients selected for therapy with a fixed combination of insulin glargine and the glucagon-like peptide-1 receptor agonist (GLP-1 RAs) lixisenatide (iGlarLixi) in real world clinical practice allows for the determination of the appropriateness and rationale for the prescriptions, as well as their compliance with existing clinical guidelines. Aim: To evaluate the type of glucose-lowering therapy before and after the prescription of iGlarLixi, to identify factors that affect glycemic control and changes in body weight over time during treatment with iGlarLixi in the real-world clinical practice. Methods: We retrospectively analyzed the data extracted from the Diabetes Registry of the Moscow Region and evaluated the components of glucose-lowering therapy (GLT) in 495 T2DM patients before and after initiation of treatment with iGlarLixi in 01.25.2019 to 06.02.2021. In addition, glycated hemoglobin (HbA1c) level and body mass index (BMI) were assessed in 95 patients before iGlarLixi administration and on treatment with categorization depending on their insulin therapy at baseline. Results: The median age of the patients who were administered iGlarLixi was 61 [54.3; 68] years; most of them were women (n = 349, 70.5%). Before iGlarLixi was prescribed, 13.3% (n = 66) of the patients had not been receiving any GLT, 47.7% (n = 236) had been taking non-insulin agents (NIAs), and 39.0% (n = 193) had been on insulin therapy. The median HbA1c level was 7.6% [6.9; 8.7], and in 29.7% of patients, the HbA1c was below 7%. In the total sample, there was a significant decrease in BMI after the administration of iGlarLixi from 35.1 kg/m2 [31.2; 40.3] to 34.7 kg/m2 [30.5; 38.1] (p = 0.011), mainly among the patients who had been on insulin treatment before, with their BMI decreasing from 35.7 [31.6; 40.4] to 34.9 [31.4; 38.0] kg/m2; p = 0.007). Regardless of the changes in body weight over time and the initial GLT, treatment with iGlarLixi was associated with a significant decrease in the HbA1c levels compared to baseline: in the patients who had been on insulin treatment from 7.5% [6.9; 9.0] to 7.1% [6.5; 7.8] (p = 0.001) and in the initially non-insulin treated patients from 7.9% [7.0; 8.9] to 7.0% [6.5; 7.8] (p 0.001). Conclusion: The study results confirm the possibility to use iGlarLixi for the initiation of insulin therapy and as an alternative to the intensification of insulin treatment. The addition of iGlarLixi to GLT regimens in the patients who had been treated with a basal insulin, promoted a decrease in HbA1c and BMI levels. In most cases, iGlarLixi was prescribed in the cases with insufficient glycemic control.