LIraglutide and Beta-cell RepAir (LIBRA) Study

Mount Sinai Hospital, Canada63 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

LiraglutideDRUG

Liraglutide administered as once daily sc injection

placeboDRUG

placebo administered as once daily sc injection

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)

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.

Time frame: 48-weeks

Secondary Outcomes

Glycemic Control

* 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

Time frame: 48 weeks

Data from ClinicalTrials.gov

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