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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 the  LIXI GetGoal  studies comparing  LIXI  and placebo. Patients were divided into baseline therapy groups: those receiving oral antidiabetes drugs ( OADs ) at baseline (n = 2760) or those receiving basal insulin at baseline (n = 1198).    Results  Compared with placebo,  LIXI  treatment led to significantly greater reductions 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 either the  OAD  (34% vs 18%;  P  < .0001) or the basal insulin groups (19% vs 10%;  P  < .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  = .0098) and basal insulin groups (27% vs 17%;  P  < .0001). 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 such a large or 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.

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