5 years ago

The 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

W. Yang, I. Li, A. Venkateshwar Rao, K. Min, E. Niemoeller, X. Xu, N. Zhang, D. Zhu, Z. Zhou, S. Shang, L. S. Murthy, L. Li
Aims To assess the effects on glycaemic control of lixisenatide versus placebo as add-on treatment to basal insulin (BI) ± metformin 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, total daily BI dose, fasting plasma glucose and safety assessments. Results Baseline demographics were similar across treatment groups. Following insulin optimization during run-in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation; 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error] change −0.62% [0.09] vs −0.11 [0.09]; p < 0.0001, respectively) and higher proportions of patients achieved HbA1c targets. 2-hour PPG, daily mean SMPG and body weight were reduced further and daily BI dose was lower with lixisenatide than placebo (–1.12 kg vs 0.04 kg [p < 0.0001]; –3.0 U vs –1.9 U [p = 0.0033], respectively). Treatment-emergent adverse events were greater with lixisenatide than placebo (63.8% vs 40.8%, respectively). The incidence of symptomatic hypoglycaemia was comparable (lixisenatide 15.6% vs placebo 13.5%). Conclusions In Asian patients insufficiently controlled on BI ± metformin, lixisenatide was superior versus placebo in glycaemic control, with a tolerability profile in line with other glucagon-like peptide-1 receptor agonists. Clinical trial number: NCT01632163 (clinicaltrials.gov).

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/dom.13072

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