Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

Summary

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Timeline

Start

2012-04-05

Primary completion

2012-11-01

Completion

2013-03-27

Outcome

Met primary endpoint

registry Lira + Insulin vs Placebo + Insulin; p <0.0001; Estimated treatment difference, Mean -1.30 (95% CI -1.47 to -1.13); ANCOVA NCT01572740 ↗

paper Superiority of liraglutide plus insulin versus insulin monotherapy was confirmed PMID 27182042 ↗

Publications

• Results Seino Y, Kaneko S, Fukuda S, Osonoi T, Shiraiwa T, Nishijima K, Bosch-Traberg H, Kaku K. Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial. J Diabetes Investig. 2016 Jul;7(4):565-73. doi: 10.1111/jdi.12457. Epub 2016 Jan 23.
• Results Kaneko S, Nishijima K, Bosch-Traberg H, Kaku K, Seino Y. Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial. J Diabetes Investig. 2018 Jul;9(4):840-849. doi: 10.1111/jdi.12793. Epub 2018 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	0.9 mg	Subcutaneous
Background	Insulin	Protein / enzyme biologic	—	—

Indications