NCT01270789

LIraglutide and Beta-cell RepAir (LIBRA) Study

A Randomized Controlled Study Assessing the Effect of Liraglutide on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes Mellitus: The LIraglutide and Beta-cell RepAir (LIBRA) Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). We propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM. This study may demonstrate an important beta-cell protective capacity of liraglutide.

Detailed description

In this study, patients with type 2 diabetes who meet randomization criteria will be randomized to either liraglutide or placebo, with serial assessment of beta-cell function over 48 weeks follow-up. The hypothesis under study is whether liraglutide can preserve beta-cell function.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Liraglutide	Liraglutide administered as once daily sc injection
DRUG	placebo	placebo administered as once daily sc injection

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-12-01
• Completion: 2014-05-01
• First posted: 2011-01-05
• Last updated: 2014-09-12

Locations

1 site across 1 country: Canada