OBJECTIVES: The fixed -ratio combination of insulin glargine (iGlar) plus lixisenatide (iGlarLixi) has proven efficacious in clinical trials; however, there is limited evidence of its benefits in diverse, real-world patients with type 2 Diabetes Mellitus (T2DM) who present in routine clinical practice.

METHODS: A large integrated claims and EHR database was used to identify two real-world cohorts (ages ≥18) with T2DM who were eligible for treatment with iGlarLixi. At baseline, the first cohort (insulin cohort) received insulins with or without oral antidiabetic drugs (OADs) and the second (OAD only cohort) received OADs only. A Monte Carlo patient-level simulation was applied to each cohort based on treatment strategies and efficacies from LixiLan- L and LixiLan-O trials to estimate reductions in glycated hemoglobin A1C (A1C) and the percentage achieving age-based A1C goals (≤7% for ages <65 and ≤8% for ages ≥65) at 30 weeks.

RESULTS: The real-world insulin (N=3,797) and OAD only (N=17,633) cohorts differed considerably in demographics, age, clinical characteristic, baseline A1C levels, and background OAD therapies compared to the populations in the Lixilan-L and Lixilan-O trials. Notwithstanding, in the insulin cohort simulation, A1C goals were achieved among 52.6% vs. 31.6% (p<0.001) of patients in the iGlarLixi vs. the iGlar arms, respectively and in the OAD only cohort simulation, A1C goals were achieved among 59.9% vs. 49.3% and 32.8% (p<0.001) of patients in the iGlarLixi vs. the iGlar, and lixisenatide arms, respectively.

CONCLUSIONS: In this patient-level simulation applied to real-world T2DM patient cohorts with different treatments at baseline, iGlarLixi was associated with greater improvement in A1C levels compared to iGlar or lixisenatide alone, suggesting that the benefits of iGlarLixi extend to clinically diverse real-world populations.