LIraglutide and Beta-cell RepAir (LIBRA) Study

Sponsor
Mount Sinai Hospital, Canada
Study ID
NCT01270789
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide administered as once daily sc injection
  • placebo — DRUG
    placebo administered as once daily sc injection

Study Details

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.

Key Dates

Start date
Jan 31, 2011
Status verified
Sep 2014
Primary completion
Dec 31, 2013
Completion
May 31, 2014

Study Design

Enrollment
63 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2) [ Time Frame: 48-weeks ]

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