LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

Summary

The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.

Timeline

Start

2017-03-03

Primary completion

2018-05-04

Completion

2018-05-08

Outcome

Met primary endpoint

registry analysis (superiority test); Liraglutide vs Placebo; p <.001; Treatment difference -0.68 (95% CI -0.89 to -0.48); pattern mixture model NCT02964247 ↗

paper Mean changes in HbA1c from baseline to week 26 with liraglutide (n = 202) and placebo (n = 100) were - 0.98% and - 0.30%, respectively PMID 31984646 ↗

Publications

• Results Blonde L, Belousova L, Fainberg U, Garcia-Hernandez PA, Jain SM, Kaltoft MS, Mosenzon O, Nafach J, Palle MS, Rea R. 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. Diabetes Obes Metab. 2020 Jun;22(6):929-937. doi: 10.1111/dom.13978. Epub 2020 Feb 14.
• Blonde L, Fainberg U, Kaltoft MS, Mosenzon O, Ramesh C, Rea R. Efficacy of liraglutide added to sodium-glucose cotransporter-2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post-hoc analysis of LIRA-ADD2SGLT2i. Diabetes Obes Metab. 2021 Oct;23(10):2234-2241. doi: 10.1111/dom.14464. Epub 2021 Jul 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	1.8 mg	Subcutaneous

Indications