Predictors of type 2 diabetes patients’ outcomes in the lixisenatide GetGoal clinical trials

Aims To explore the treatment outcomes in adult patients with type 2 diabetes (T2D) enrolled in the GetGoal trials of lixisenatide (LIXI), and the predictive effects of baseline characteristics on outcomes. Methods This study was a pooled analysis of patient-level data from LIXI GetGoal studies comparing LIXI and placebo. Patients were divided into baseline therapy groups: oral antihyperglycaemic drugs (OADs) at baseline (n = 2,760) or basal insulin at baseline (n = 1,198). Results LIXI treatment, compared to placebo, led to significantly greater reduction in glycated haemoglobin (HbA1c), and greater achievement of the composite endpoint of HbA1c <7.0% (53 mmol/mol) with no symptomatic hypoglycaemia and no weight gain in both the OAD (34% vs 18%, p < 0.0001) and basal insulin groups (19% vs 10%, p < 0.0001). Treatment with LIXI was associated with a greater percentage of patients experiencing a symptomatic hypoglycaemic event compared with placebo in both the OAD (5% vs 3%, p = 0.0098) and basal insulin (27% vs 17%, p < 0.0001) groups. In assessing baseline factors that were predictors of treatment outcomes, only baseline HbA1c and LIXI treatment were strong predictors of outcomes in both the OAD and basal insulin groups. No other baseline characteristic had as large or as consistent clinically relevant predictive effect across treatment outcomes. Conclusions The results from this study show that irrespective of baseline characteristics, LIXI treatment, as an add-on to OAD or basal insulin therapy, is effective in reducing HbA1c and achieving composite endpoints.