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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
Author(s) -
Blonde Lawrence,
Fainberg Udi,
Kaltoft Margit S.,
Mosenzon Ofri,
Ramesh Chethana,
Rea Rosangela
Publication year - 2021
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.14464
Subject(s) - liraglutide , medicine , type 2 diabetes , waist , placebo , post hoc analysis , body mass index , insulin resistance , diabetes mellitus , lira , confidence interval , metformin , obesity , endocrinology , insulin , alternative medicine , pathology , exchange rate , economics , macroeconomics
Abstract 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.