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.
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.
Kansai Electric Power Hospital, 2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan; Kansai Electric Power Medical Research Institute, 1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan; Kobe University Graduate School of Medicine, 1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan. Electronic address: ydaisuke-kyoto@umin.ac.jp.
Daisuke
D
Yabe
North Estonia Medical Center, 19 Sütiste Street, 13419 Tallinn, Estonia. Electronic address: Anu.Ambos@regionaalhaigla.ee.
Anu
A
Ambos
The Thorax Institute, CHU Nantes, Boulevard Jacques Monod, F-44093 Nantes, France. Electronic address: Bertrand.Cariou@univ-nantes.fr.
Bertrand
B
Cariou
Vuk Vrhovac Clinic-Merkur University Hospital, University of Zagreb, Dugi dol 4a, 10000 Zagreb, Croatia. Electronic address: lduvnjak@idb.hr.
Lea
L
Duvnjak
University Hospital Llandough, Penlan Road Llandough, CF64 2XX, UK. Electronic address: marcevans4@sky.com.
Marc
M
Evans
Jalisco Institute of Diabetes and Obesity Research SC, Morelos 1952, Guadalajara, CP 44600, Mexico. Electronic address: doctorggg@gmail.com.
Guillermo
G
González-Gálvez
Novosys Health, 7 Crestmont Court, Flemington, NJ 08822, USA. Electronic address: jay.lin@novosyshealth.com.
Jay
J
Lin
Artech Information Systems, LLC, 360 Mt. Kemble Ave. #2000, Morristown, NJ 07960, USA. Electronic address: Elena.Nikonova@sanofi.com.
Elena V
EV
Nikonova
Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, Barranco de la Ballena sn, 35010 Las Palmas de Gran Canaria, Spain. Electronic address: pablos.velasco@ulpgc.es.
Pedro
P
de Pablos-Velasco
McGill University, 687 Pine Avenue West, Montréal, QC H3A 1A1, Canada. Electronic address: jean-francois.yale@mcgill.ca.
Jean-François
JF
Yale
Lund University, Sölvegatan 19, SE-22184 Lund, Sweden. Electronic address: bo.ahren@med.lu.se.
Bo
B
Ahrén
D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D050417:Insulin-Secreting Cells / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D000067758:Glucagon-Like Peptide-2 Receptor
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010455:Peptides; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
Antidiabetic drug; Beta cell; GLP-1 analog; Glycemic control; Type 2 diabetes