LIraglutide and Beta-cell RepAir (LIBRA) Study
- Registration Number
- NCT01270789
- Lead Sponsor
- Mount Sinai Hospital, Canada
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Liraglutide Liraglutide -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada