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LIBRA

CompletedPhase 3

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

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

63

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 5.5-9%

Primary endpoint

Preservation of beta-cell function

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01270789
Org study ID10-0230-A

Timeline

Milestones

Study first posted2011-01-05estimated
Last update posted2014-09-12estimated
Study start2011-01 (month precision)
Primary completion2013-12actual (month precision)
Study completion2014-05actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

men and women between the ages of 30 and 75 years inclusive
physician-diagnosed type 2 diabetes of </= 7 years duration
negative for anti-GAD antibodies
on 0-2 oral anti-diabetic medications
A1c at screening between 5.5% and 9.0% inclusive, if on oral anti-diabetic medications, or between 6.0% and 10.0% inclusive, if not on oral anti-diabetic medications

Exclusion criteria

use of insulin, GLP-1 agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitor
type 1 diabetes or secondary forms of diabetes
major illness with life expectancy < 5 years
involvement in another study requiring drug therapy
hypersensitivity to insulin, liraglutide, or metformin
renal dysfunction
hepatic dysfunction
history of pancreatitis
family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma
personal history of non-familial medullary thyroid carcinoma
malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
excessive alcohol consumption
unwillingness to undergo multiple daily insulin injection therapy
unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy
congestive heart failure
pregnancy

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)

Time frame:48-weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Glycemic Control

Time frame:48 weeks

descriptive, improvement

Publications (9)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.