Introduction: iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and the glucagon-like peptide 1 receptor agonist (GLP-1 RA) lixisenatide, is one option for treatment intensification in individuals with type 2 diabetes (T2D) who are unable to achieve targeted glycaemic control with their current glucose-lowering agent. Real-world data on the impact of prior treatment on the effectiveness and safety of iGlarLixi may be useful to guide individualised treatment decisions.
Methods: This analysis of the 6-month, retrospective, observational SPARTA Japan study compared glycated haemoglobin (HbA1c), body weight and safety for pre-specified subgroups defined by prior treatment: post oral antidiabetic agent (OAD), GLP-1 RA, basal insulin (BI) + OADs (BOT), GLP-1 RA + BI or multiple daily injections (MDI). The post BOT and MDI subgroups were further divided on the basis of prior dipeptidyl peptidase 4 inhibitor (DPP-4i) use, and the post MDI group was divided on the basis of whether participants continued bolus insulin.
Results: Of the 432 participants in the full analysis set (FAS), 337 were included in this subgroup analysis. Across subgroups, mean baseline HbA1c ranged from 8.49% to 9.18%. iGlarLixi significantly (p < 0.05) reduced mean HbA1c from baseline in all but the post GLP-1 RA + BI group. At 6 months, these significant reductions ranged from 0.47% to 1.27%. Prior DPP-4i exposure had no impact on the HbA1c-lowering effect of iGlarLixi. Mean body weight decreased significantly in the FAS (0.5 kg) and the post BOT (1.2 kg) and MDI (1.5 and 1.9 kg) subgroups but increased in the post GLP-1 RA subgroup (1.3 kg). iGlarLixi treatment was generally well tolerated, with very few participants discontinuing because of hypoglycaemia or gastrointestinal events.
Conclusion: In participants with suboptimal glycaemic control on various regimens, 6 months of iGlarLixi treatment improved HbA1c in all but one prior treatment subgroup (GLP-1 RA + BI), and was generally well tolerated.
Trial registration: UMIN-CTR Trials Registry, UMIN000044126; registered 10 May 2021.
Keywords: Fixed-ratio combination; Insulin glargine; Japan; Lixisenatide; Real-world data; Type 2 diabetes mellitus; iGlarLixi.
Plain language summary
Despite initially receiving oral treatment for their diabetes, many individuals with type 2 diabetes are unable to achieve their blood glucose targets and require treatment intensification as their disease progresses. In these individuals, options for treatment intensification include adding an injectable therapy, such as a glucagon-like peptide 1 receptor agonist or basal insulin, or the combination of both. However, the impact of previously received treatments on the ability of treatment intensification to improve outcomes in these individuals has yet to be evaluated. Here, we report the findings of an analysis that aimed to determine the influence of different treatment backgrounds on the effectiveness and safety of iGlarLixi, a fixed-ratio combination (i.e. combined as a single subcutaneous injection) of the glucagon-like peptide 1 receptor agonist lixisenatide and basal insulin glargine 100 U/mL, in Japanese individuals with type 2 diabetes. We found that iGlarLixi improved glycaemic control and was well tolerated in most individuals, regardless of previously received treatments. These results suggest that iGlarLixi may offer an effective option for improving outcomes in Japanese individuals with type 2 diabetes who require treatment intensification.
© 2023. The Author(s).
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