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Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i

AIMS: The LIRA‐ADD2SGLT2i trial demonstrated that liraglutide + sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) ± metformin significantly improved glycaemic control (not body weight) versus placebo in adults with type 2 diabetes (T2D). This post‐hoc analysis assessed whether baseline characteris...

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Autores principales: Blonde, Lawrence, Fainberg, Udi, Kaltoft, Margit S., Mosenzon, Ofri, Ramesh, Chethana, Rea, Rosangela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518913/
https://www.ncbi.nlm.nih.gov/pubmed/34132018
http://dx.doi.org/10.1111/dom.14464
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author Blonde, Lawrence
Fainberg, Udi
Kaltoft, Margit S.
Mosenzon, Ofri
Ramesh, Chethana
Rea, Rosangela
author_facet Blonde, Lawrence
Fainberg, Udi
Kaltoft, Margit S.
Mosenzon, Ofri
Ramesh, Chethana
Rea, Rosangela
author_sort Blonde, Lawrence
collection PubMed
description AIMS: The LIRA‐ADD2SGLT2i trial demonstrated that liraglutide + sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) ± metformin significantly improved glycaemic control (not body weight) versus placebo in adults with type 2 diabetes (T2D). This post‐hoc analysis assessed whether baseline characteristics influenced these findings. MATERIALS AND METHODS: LIRA‐ADD2SGLT2i (NCT02964247) was a placebo‐controlled, double‐blind, multinational trial, wherein participants received liraglutide (≤1.8 mg/day) or placebo (randomized 2:1). Changes from baseline to week 26 in haemoglobin A1c (HbA1c), body weight and waist circumference stratified by HbA1c, body mass index (BMI), diabetes duration, duration of pre‐trial SGLT2i use and Homeostatic Model Assessment of Insulin Resistance (HOMA‐IR) were analysed. These five baseline characteristics were divided into tertiles, and the treatment effect was evaluated using the trial product estimand. RESULTS: Data from all 303 participants were analysed. There was a significant interaction between baseline HbA1c tertiles (7.0%‐<7.6%; 7.6%‐8.1%; ≥8.2%‐9.5%) and glycaemic control at week 26 (p ([interaction]) = .011), with the lowest HbA1c estimated treatment difference (95% confidence interval) observed in patients with lowest baseline HbA1c [−0.20% (−0.59, 0.19); −0.68% (−1.03, −0.33); −0.98% (−1.33, −0.64), respectively]. There were no significant interactions in glycaemic control across baseline BMI, diabetes duration, insulin resistance determined by HOMA‐IR or SGLT2i use duration (p ([interaction]) > .05, all). Across the five characteristics assessed, no significant interactions were found for body weight or waist circumference changes from baseline (p ([interaction]) > .05, all). CONCLUSION: For individuals with T2D and inadequate glycaemic control despite therapy with SGLT2is ± metformin, liraglutide 1.8 mg would provide an effective treatment intensification option, irrespective of HbA1c, BMI, diabetes duration, insulin resistance determined by HOMA‐IR and SGLT2i use duration.
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spelling pubmed-85189132021-10-21 Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i Blonde, Lawrence Fainberg, Udi Kaltoft, Margit S. Mosenzon, Ofri Ramesh, Chethana Rea, Rosangela Diabetes Obes Metab Original Articles AIMS: The LIRA‐ADD2SGLT2i trial demonstrated that liraglutide + sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) ± metformin significantly improved glycaemic control (not body weight) versus placebo in adults with type 2 diabetes (T2D). This post‐hoc analysis assessed whether baseline characteristics influenced these findings. MATERIALS AND METHODS: LIRA‐ADD2SGLT2i (NCT02964247) was a placebo‐controlled, double‐blind, multinational trial, wherein participants received liraglutide (≤1.8 mg/day) or placebo (randomized 2:1). Changes from baseline to week 26 in haemoglobin A1c (HbA1c), body weight and waist circumference stratified by HbA1c, body mass index (BMI), diabetes duration, duration of pre‐trial SGLT2i use and Homeostatic Model Assessment of Insulin Resistance (HOMA‐IR) were analysed. These five baseline characteristics were divided into tertiles, and the treatment effect was evaluated using the trial product estimand. RESULTS: Data from all 303 participants were analysed. There was a significant interaction between baseline HbA1c tertiles (7.0%‐<7.6%; 7.6%‐8.1%; ≥8.2%‐9.5%) and glycaemic control at week 26 (p ([interaction]) = .011), with the lowest HbA1c estimated treatment difference (95% confidence interval) observed in patients with lowest baseline HbA1c [−0.20% (−0.59, 0.19); −0.68% (−1.03, −0.33); −0.98% (−1.33, −0.64), respectively]. There were no significant interactions in glycaemic control across baseline BMI, diabetes duration, insulin resistance determined by HOMA‐IR or SGLT2i use duration (p ([interaction]) > .05, all). Across the five characteristics assessed, no significant interactions were found for body weight or waist circumference changes from baseline (p ([interaction]) > .05, all). CONCLUSION: For individuals with T2D and inadequate glycaemic control despite therapy with SGLT2is ± metformin, liraglutide 1.8 mg would provide an effective treatment intensification option, irrespective of HbA1c, BMI, diabetes duration, insulin resistance determined by HOMA‐IR and SGLT2i use duration. Blackwell Publishing Ltd 2021-07-08 2021-10 /pmc/articles/PMC8518913/ /pubmed/34132018 http://dx.doi.org/10.1111/dom.14464 Text en © 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Blonde, Lawrence
Fainberg, Udi
Kaltoft, Margit S.
Mosenzon, Ofri
Ramesh, Chethana
Rea, Rosangela
Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i
title Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i
title_full Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i
title_fullStr Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i
title_full_unstemmed Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i
title_short Efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post‐hoc analysis of LIRA‐ADD2SGLT2i
title_sort efficacy of liraglutide added to sodium‐glucose cotransporter‐2 inhibitors in type 2 diabetes, stratified by baseline characteristics: post‐hoc analysis of lira‐add2sglt2i
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518913/
https://www.ncbi.nlm.nih.gov/pubmed/34132018
http://dx.doi.org/10.1111/dom.14464
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