Efficacy of lixisenatide in patients with type 2 diabetes: a post hoc analysis of patients with diverse β-cell function in the GetGoal-M and GetGoal-S trials
Yabe, D.; Ambos, A.; Cariou, B.; Duvnjak, L.; Evans, M.; González-Gálvez, G.; Lin, J.; Nikonova, E.V.; de Pablos-Velasco, P.; Yale, J.-F.ço.; Ahrén, B.
Journal of Diabetes and its Complications 30(7): 1385-1392
ISSN/ISBN: 1873-460X PMID: 27267268 DOI: 10.1016/j.jdiacomp.2016.05.018
To evaluate the impact of β-cell function on the efficacy of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in patients with type 2 diabetes (T2D). In this post hoc analysis, patients from the Phase 3 GetGoal-M and GetGoal-S clinical trials randomized to lixisenatide 20μg once daily were stratified into quartiles by baseline β-cell function, as measured by the secretory units of islet in transplantation (SUIT) index. Patients (N=437) were distributed evenly among SUIT index quartiles 1 to 4 (lowest to highest β-cell function). Clinical outcomes improved from baseline across all SUIT quartiles; mean changes at week 24 were: glycated hemoglobin (HbA1c; % [mmol/mol]), -0.99 (-10.8), -0.87 (-9.5), -0.86 (-9.4), -0.83 (-9.1); and postprandial plasma glucose (PPG; mmol/L), -7.9, -5.6, -5.5, -4.3 (overall effect P<0.0001). Furthermore, postprandial glucagon was reduced in all SUIT quartiles, while insulinogenic index improved only in patients with higher baseline SUIT (overall effect P=0.0286). No severe symptomatic hypoglycemic events were reported. Lixisenatide treatment resulted in reductions in HbA1c and PPG levels across all SUIT quartiles. This suggests that non-insulin-related actions of lixisenatide contribute to improved glycemic control in T2D.