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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Liraglutide
Intervention: Liraglutide (Drug)
Placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Time Frame: 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 Outcomes
- Glycemic Control(48 weeks)