NCT02964247

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	liraglutide	Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks
DRUG	placebo	Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-05-04
• Completion: 2018-05-08
• First posted: 2016-11-16
• Last updated: 2020-11-17
• Results posted: 2019-07-10

Locations

82 sites across 7 countries: United States, Brazil, India, Israel, Puerto Rico, Russia, United Arab Emirates

Regulatory

• FDA-regulated drug study