Liraglutide as add-on to sodium-glucose co-transporter-2 inhibitors in patients with inadequately controlled type 2 diabetes: LIRA-ADD2SGLT2i, a 26-week, randomized, double-blind, placebo-controlled trial Article

Full Text via DOI: 10.1111/dom.13978 PMID: 31984646 Web of Science: 000513198700001
Industry Collaboration International Collaboration

Cited authors

  • Blonde, Lawrence; Belousova, Lidia; Fainberg, Udi; Garcia-Hernandez, Pedro A.; Jain, Sunil M.; Kaltoft, Margit S.; Mosenzon, Ofri; Nafach, Jalal; Palle, Mads Sundby; Rea, Rosangela

Abstract

  • Aim To compare the effect of liraglutide or placebo added on to sodium-glucose co-transporter-2 inhibitor (SGLT2i) +/- metformin on glycaemic control in patients with type 2 diabetes.; Materials and Methods Patients with type 2 diabetes on a stable SGLT2i dose +/- metformin (with HbA1c 7.0%-9.5% and body mass index [BMI] >= 20 kg/m(2)) were randomized 2:1 to add-on liraglutide 1.8 mg/day or placebo in this parallel, double-blind, multinational trial. Primary and confirmatory secondary endpoints were changes in HbA1c and body weight from baseline to week 26, respectively. The proportions of patients achieving HbA1c (<7.0%) targets and safety events after week 26 were also assessed.; Results Of 303 patients randomized (one in error), 280 completed treatment. Mean changes in HbA1c from baseline to week 26 with liraglutide (n = 202) and placebo (n = 100) were -0.98% and -0.30%, respectively (estimated treatment difference [ETD]: -0.68% [95% CI: -0.89, -0.48]; P < 0.001). Mean body weight changes from baseline were -2.81 versus -1.99 kg, respectively (ETD: -0.82 kg [95% CI: -1.73, 0.09]; P = 0.077); 51.8% of liraglutide-treated patients achieved HbA1c <7.0% versus 23.2% receiving placebo (odds ratio: 5.1 [95% CI: 2.67, 9.87]; P < 0.001). More patients treated with liraglutide reported >= 1 treatment-emergent adverse events (66.3%) versus placebo (47.0%).; Conclusions Liraglutide significantly improved glycaemic control compared with placebo in patients with type 2 diabetes, insufficiently controlled with SGLT2is with/without metformin, with no unexpected safety findings.

Publication date

  • 2020

Published in

International Standard Serial Number (ISSN)

  • 1462-8902

Start page

  • 929

End page

  • 937

Volume

  • 22

Issue

  • 6