TY - JOUR
T1 - A pilot clinical study to Evaluate Liraglutide-mediated Anti-platelet activity in patients with type-2 Diabetes (ELAID study)
AU - Loganathan, Jayasree
AU - Cohen, Adam C.
AU - Kaloupis, Georgia M.
AU - Harris, Carolyn
AU - Chronopoulos, Andriana
AU - James, Vanessa
AU - Hamilton, Justin
AU - Green, Sarah
AU - Wallis, Andrew
AU - Morgan, Susan
AU - Dauer, Raymond
AU - Gilfillan, Christopher
AU - Dear, Anthony E.
N1 - Funding Information:
This work was supported, in part, by an investigator-initiated research grant from Novo Nordisk . Novo Nordisk did not have any role in the study design or in the collection, analysis and interpretation of data or in the writing of the report or decision to submit for publication.
Funding Information:
A six-month, phase 4 (post-marketing), two-arm, single site, randomised, double-blind, placebo-controlled, pilot clinical trial was undertaken to evaluate the effect of liraglutide 1.8 mg/day on platelet aggregation in patients with well controlled type 2 diabetes (HbA1C 7.0–8.0%) 17 , without macrovascular disease or concurrent anti-platelet therapy. The study was conducted in accordance with Good Clinical Practice (GCP) guidelines as per International Conference of Harmonization requirements with the approval and oversight of the Eastern Health Ethics Committee (HREC/17/EH/34, E05-2017). The trial was allocated the universal trial number (UTN) 1111-1181-9567. The trial was, in part, funded by Novo Nordisk and conducted by the Principal Investigator A/Prof Anthony E Dear at Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Australia.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/5
Y1 - 2022/5
N2 - Background: Liraglutide is an effective treatment for the management of type 2 diabetes mellitus (T2DM). In addition to glycemic control and potential cardioprotective effects, recent studies suggest a possible role for liraglutide in the inhibition of platelet reactivity, further attenuating atherothrombotic risk in patients with T2DM. We evaluated the in-vivo antiplatelet effect of liraglutide in T2DM patients without macrovascular disease or concurrent anti-platelet therapy. Methods: A double-blind, placebo-controlled pilot study of 16 T2DM patients, 51–69 y/o, (mean age 60.4 y/o, 63.0% male) randomised to receive liraglutide (1.8 mg/day) or placebo (saline) for 6 months was conducted. Platelet aggregation studies at baseline and after initiation of the study intervention: days 1, 7, and 14 and months 1, 3 and 6 were performed. Results: Liraglutide (n = 7) and placebo (n = 9) treated patients demonstrated normal platelet aggregation responses although transient and significant attenuation in maximum slope of platelet aggregation in response to collagen (p ≤ 0.05), arachidonic acid (p ≤ 0.05) and ADP (p ≤ 0.02) was observed in liraglutide compared to placebo treated patients in the first week. Conclusions: In this pilot study of patients with T2DM liraglutide treatment was associated with a significant, early and transient decrease in maximum slope of platelet aggregation. The clinical significance of this effect is currently unknown and may warrant further investigation. Clinical Trial Registration Number: UTN 1111-1181-9567.
AB - Background: Liraglutide is an effective treatment for the management of type 2 diabetes mellitus (T2DM). In addition to glycemic control and potential cardioprotective effects, recent studies suggest a possible role for liraglutide in the inhibition of platelet reactivity, further attenuating atherothrombotic risk in patients with T2DM. We evaluated the in-vivo antiplatelet effect of liraglutide in T2DM patients without macrovascular disease or concurrent anti-platelet therapy. Methods: A double-blind, placebo-controlled pilot study of 16 T2DM patients, 51–69 y/o, (mean age 60.4 y/o, 63.0% male) randomised to receive liraglutide (1.8 mg/day) or placebo (saline) for 6 months was conducted. Platelet aggregation studies at baseline and after initiation of the study intervention: days 1, 7, and 14 and months 1, 3 and 6 were performed. Results: Liraglutide (n = 7) and placebo (n = 9) treated patients demonstrated normal platelet aggregation responses although transient and significant attenuation in maximum slope of platelet aggregation in response to collagen (p ≤ 0.05), arachidonic acid (p ≤ 0.05) and ADP (p ≤ 0.02) was observed in liraglutide compared to placebo treated patients in the first week. Conclusions: In this pilot study of patients with T2DM liraglutide treatment was associated with a significant, early and transient decrease in maximum slope of platelet aggregation. The clinical significance of this effect is currently unknown and may warrant further investigation. Clinical Trial Registration Number: UTN 1111-1181-9567.
KW - Antiplatelet
KW - Glucagon-like peptide-1 receptor (GLP-1R)
KW - Liraglutide
KW - Thrombosis
KW - Type 2 diabetes mellitus
UR - http://www.scopus.com/inward/record.url?scp=85127581137&partnerID=8YFLogxK
U2 - 10.1016/j.jdiacomp.2022.108188
DO - 10.1016/j.jdiacomp.2022.108188
M3 - Article
C2 - 35382966
AN - SCOPUS:85127581137
SN - 1056-8727
VL - 36
JO - Journal of Diabetes and its Complications
JF - Journal of Diabetes and its Complications
IS - 5
M1 - 108188
ER -