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
Daisuke Yabe, Anu Ambos, Bertrand Cariou, Lea Duvnjak, Marc Evans, Guillermo González-Gálvez, Jay Lin, Elena V Nikonova, Pedro de Pablos-Velasco, Jean-François Yale, Bo Ahrén, Daisuke Yabe, Anu Ambos, Bertrand Cariou, Lea Duvnjak, Marc Evans, Guillermo González-Gálvez, Jay Lin, Elena V Nikonova, Pedro de Pablos-Velasco, Jean-François Yale, Bo Ahrén
Abstract
Aims: 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).
Materials and methods: 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.
Results: 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.
Conclusions: 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.
Trial registration: ClinicalTrials.gov NCT00712673 NCT00713830.
Keywords: Antidiabetic drug; Beta cell; GLP-1 analog; Glycemic control; Type 2 diabetes.
Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed