Simultaneous Versus Sequential Initiation of Lixisenatide and Basal Insulin for Type 2 Diabetes: Subgroup Analysis of a Japanese Post-Marketing Surveillance Study of Lixisenatide (PRANDIAL).

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.