Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

NCT01907854 ↗

Phase 4 Completed 407 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.

Timeline

Start: 2013-12-02
Primary completion: 2015-06-15
Completion: 2015-06-15

Outcome

Met primary endpoint

registry analysis (superiority or other test); Liraglutide vs Sitagliptin; p <0.0001; Treatment difference -0.61 (95% CI -0.82 to -0.40); Mixed Models Analysis NCT01907854 ↗

paper Greater reduction in mean HbA1c was achieved with liraglutide than with continued sitagliptin PMID 27381275 ↗

Publications

Results Bailey TS, Takacs R, Tinahones FJ, Rao PV, Tsoukas GM, Thomsen AB, Kaltoft MS, Maislos M. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016 Dec;18(12):1191-1198. doi: 10.1111/dom.12736. Epub 2016 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	1.8 mg	Subcutaneous
Subject	Sitagliptin	Small molecule	100 mg	—