Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal‐L‐C randomized trial

AIMS: To assess the effects on glycaemic control of lixisenatide vs placebo as add‐on treatment to basal insulin (BI) ± metformin and effects on glycated haemoglobin (HbA1c) reduction in patients with insufficiently controlled type 2 diabetes (T2D). METHODS: Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add‐on to BI ± metformin for 24 weeks after an 8‐week run‐in phase, during which BI was titrated to a target self‐monitored plasma glucose (SMPG; 4.4‐5.6 mmol/L). The primary endpoint was absolute change in HbA1c from baseline to week 24. Secondary efficacy endpoints included: percentage of responders; changes in 2‐hour postprandial plasma glucose (PPG); 7‐point SMPG (daily average); body weight (BW); total daily BI dose; fasting plasma glucose; and safety assessments. RESULTS: Baseline demographics were similar in the two treatment groups. After insulin optimization during run‐in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation {s.d.}, 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error {s.e.}] change −0.62% [0.09] vs −0.11% [0.09]; P < .0001, respectively) and higher proportions of patients achieved HbA1c targets. Two‐hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (−1.12 kg vs 0.04 kg [P < .0001]; −3.0 U vs −1.9 U [P = .0033], respectively). Treatment‐emergent adverse events were greater with lixisenatide than placebo (63.8% vs 40.8%, respectively). The incidence of symptomatic hypoglycaemia was similar (lixisenatide 15.6% vs placebo 13.5%). CONCLUSIONS: In Asian patients insufficiently controlled on BI ± metformin, lixisenatide was superior to placebo in glycaemic control, with a tolerability profile in line with other glucagon‐like peptide‐1 receptor agonists. CLINICAL TRIAL NUMBER: NCT01632163 (clinicaltrials.gov).