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LIraglutide and Beta-cell RepAir (LIBRA) Study

NCT01270789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-09-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Liraglutide

Liraglutide administered as once daily sc injection

DRUG

placebo

placebo administered as once daily sc injection

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Ravi Retnakaran, MD · Mount Sinai Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2014-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01270789 on ClinicalTrials.gov