LIraglutide and Beta-cell RepAir (LIBRA) Study
Information source: Mount Sinai Hospital, Canada
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Liraglutide (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Mount Sinai Hospital, Canada Official(s) and/or principal investigator(s):
Ravi Retnakaran, MD, Principal Investigator, Affiliation: Mount Sinai Hospital, New York
Overall contact:
Ravi Retnakaran, MD, Phone: 416-586-4800, Ext: 3941, Email: rretnakaran@mtsinai.on.ca
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Secondary outcome: Glycemic Control
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.
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- men and women between the ages of 30 and 75 years inclusive
- physician-diagnosed type 2 diabetes of
- 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
Locations and Contacts
Ravi Retnakaran, MD, Phone: 416-586-4800, Ext: 3941, Email: rretnakaran@mtsinai.on.ca
Mount Sinai Hospital, Toronto, Ontario M5G1X5, Canada; Recruiting
Ravi Retnakaran, MD, Principal Investigator
Bernard Zinman, MD, Principal Investigator
Additional Information
Starting date: January 2011
Last updated: December 19, 2012
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