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LIraglutide and Beta-cell RepAir (LIBRA) Study

Sponsor
Mount Sinai Hospital, Canada (Other)
Overall Status
Completed
CT.gov ID
NCT01270789
Collaborator
Novo Nordisk A/S (Industry)
63
Enrollment
1
Location
2
Arms
40
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liraglutide

Drug: Liraglutide
Liraglutide administered as once daily sc injection
Other Names:
  • Victoza

    		•
    Placebo Comparator: Placebo

    Drug: placebo
    placebo administered as once daily sc injection

    Outcome Measures

    Primary Outcome Measures

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

      ISSI-2 is a validated OGTT-derived measure of beta-cell function analogous to the disposition index obtained from the intravenous glucose tolerance test. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve (AUCins) to the area-under-the-glucose curve (AUCgluc) and (ii) insulin sensitivity measured by the Matsuda index.

    Secondary Outcome Measures

    1. Glycemic Control [48 weeks]

      A1c Fasting glucose, 2 hour glucose, and AUCgluc on OGTT Proportion of participants with A1c <7% at study end Glucose tolerance status at study end (NGT, pre-diabetes, diabetes) Proportion of participants with fasting glucose in non-diabetic range at study end (ie. <7.0 mmol/L) Time to loss of glycemic control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Hospital Toronto Ontario Canada M5G1X5

    Sponsors and Collaborators

    • Mount Sinai Hospital, Canada
    • Novo Nordisk A/S

    Investigators

    • Principal Investigator: Ravi Retnakaran, MD, Mount Sinai Hospital, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mount Sinai Hospital, Canada
    ClinicalTrials.gov Identifier:
    NCT01270789
    Other Study ID Numbers:
    • 10-0230-A
    First Posted:
    Jan 5, 2011
    Last Update Posted:
    Sep 12, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Mount Sinai Hospital, Canada
    beta-cell function
    GLP-1 analogue
    diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Liraglutide

    Study Results

    No Results Posted as of Sep 12, 2014