Introduction: Many individuals with type 2 diabetes (T2D) experience suboptimal glycemic control. Treatment intensification options include fixed-ratio combination products containing a basal insulin and a glucagon-like peptide-1 receptor agonist, such as iGlarLixi (insulin glargine 100 U/mL and lixisenatide). This study aimed to provide real-world evidence of the effect of iGlarLixi in Japanese clinical practice. Methods: SPARTA Japan was a non-comparative, observational study conducted at 27 institutions in Japan. Anonymized individuallevel data from adults with T2D receiving iGlar-Lixi in routine clinical practice were retrospectively collected. The primary study objective was to assess the impact of iGlarLixi on the change in glycated hemoglobin (HbA1c) at 6 months' posttreatment initiation, with preplanned subanalyses to determine the influence of baseline characteristics. Secondary and exploratory endpoints included assessment of the proportion of individuals achieving HbA1c targets, change in body weight, and incidence and severity of hypoglycemia and gastrointestinal events. Results: The full analysis set included 432 individuals, with data available at 6 months for 426. Of the 432 individuals, the mean (SD) age at baseline was 61.6 (12.8) years and the

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 glucoselowering 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

Introduction We aimed to assess the efficacy and safety of lixisenatide and basal insulin (BI) according to timing of treatment initiation, treatment compliance, and number of concomitant daily injections in Japanese individuals with type 2 diabetes (T2D). Methods Each substudy analyzed subgroup data from the 3-year post-marketing surveillance PRANDIAL study. Endpoints included glycated hemoglobin (HbA1c), postprandial glucose, treatment response (HbA1c < 7.0% at week 24 and 156), and safety. Changes in HbA1c levels were analyzed using paired t tests; between-group comparisons were made using analysis of variance (ANOVA). Results Of 2679 participants, 46.5% initiated BI before lixisenatide, 12.0% the same day, 2.7% between 1 and 90 days, and 2.8% at 91 or more days after lixisenatide; 36.0% did not receive BI. Overall, 85.4% of patients were compliant with lixisenatide treatment. The majority of patients (52.4%) received two injections/day (one was lixisenatide). Compared with other subgroups taking BI and lixisenatide, the subgroup starting them simultaneously had a mean change in HbA1c of − 0.69% [8 mmol/mol] (vs + 0.07% [0.8 mmol/mol] to − 0.79% [9 mmol/mol]) and numerically higher treatment response (21.0% vs 8.3–18.7%), but more hypoglycemia (8.1% vs 2.3–2.8%). Conclusions Japanese people with T2D achieved better glycemic control by simultaneous as opposed to sequential initiation of lixisenatide and BI. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02311-1.