LIraglutide and Beta-cell RepAir (LIBRA) Study

Mount Sinai Hospital, Canada

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: placebo

Drug: Liraglutide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01270789

10-0230-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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