Beneficial effect of lixisenatide after 76 weeks of treatment in patients with type 2 diabetes mellitus: A meta‐analysis from the GetGoal programme

Aims To evaluate the long‐term efficacy and safety of lixisenatide, a short‐acting, prandial glucagon‐like peptide‐1 receptor agonists ( GLP ‐1 RA ) as add‐on therapy in type 2 diabetes mellitus. Methods A meta‐analysis of 76‐week results of 5 placebo‐controlled clinical trials from the GetGoal programme was performed, including 3000 inadequately controlled adult diabetic patients where lixisenatide 20 µg once‐daily was administered in combination with metformin ( GetGoal‐M and GetGoal‐F1 ), sulphonylurea ± metformin ( GetGoal‐S ), basal insulin ± metformin ( GetGoal‐L ) or pioglitazone ± metformin ( GetGoal‐P ). Results A significant reduction in HbA1c at 76 weeks was observed in the intervention arm compared to placebo ( LSM difference: −0.41%, 95% CI : −0.51, −0.32, P < .00001). Compared to placebo, lixisenatide induced a larger decrease in fasting plasma glucose ( LSM difference −0.49 mmol/L, 95% CI −0.71, −0.27, P < .0001) and postprandial glucose excursion after a standard test meal ( LSM difference −3.29 mmol/L, 95% CI −4.17, −2.42, P < .00001). A bodyweight reduction was observed in the lixisenatide arm ( LSM difference −0.40 kg, 95% CI : −0.8, −0.01, P = .05). The risk of hypoglycaemia was slightly higher with lixisenatide vs placebo (risk difference +0.02, 95% CI : 0, 0.04, P = .04). The most commonly observed non‐severe adverse events were nausea and vomiting, which after week 16 and week 8, were steadily <4% and <1% in the lixisenatide arm, respectively. Conclusions Lixisenatide, a once‐daily prandial GLP ‐1 RA , provides long‐term glycaemic control, a sustained beneficial effect on weight and with a good safety profile.