LIraglutide and Beta-cell RepAir (LIBRA) Study

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

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