The safety and efficacy of lixisenatide (LIXI), a new once-daily prandial glucagon-like peptide-1 receptor agonist, has been evaluated as add-on to basal insulin ± oral antidiabetic drugs (OADs) in three Phase III, randomized, placebo (PBO)-controlled trials (GetGoal-L, -Duo1 and -L Asia) in Type 2 diabetes mellitus (T2DM). Endpoints included glycated hemoglobin (HbA_1c), weight, insulin dose, fasting blood glucose, postprandial glucose and hypoglycemia. A meta-analysis was performed on the safety and efficacy outcomes in 1198 patients (mean age: 57.2 yrs; diabetes duration: 11.7 yrs; Body Mass Index: 30.3 kg/m²) enrolled to these trials, using a random effects model (RevMan). A significantly higher proportion of LIXI-treated patients achieved HbA_1c<7% vs PBO (odds ratio [OR] 3.67, confidence interval [CI] 1.64, 8.19; p=0.002). Furthermore, LIXI was more than 3´ as likely to result in HbA_1c<7% and no weight gain (OR 3.35, CI 1.66, 6.77; p=0.0008), and more than 2.5 times as likely to result in either: i) HbA_1c<7% + no documented symptomatic hypoglycemia (OR 2.65, CI 1.30, 5.38; p=0.007); or ii) HbA_1c<7% + no weight gain + no documented symptomatic hypoglycemia (OR 2.64, CI 1.48, 4.70; p=0.0009) (Table). In patients with T2DM, LIXI as add-on to basal insulin ± OADs is significantly more effective than PBO in achieving HbA_1c <7%, and is more than 2.5´ as likely to result in HbA_1c<7% with no documented hypoglycemia and no weight gain; it is, therefore, an attractive potential option as add-on to treatment with basal insulin.