LIraglutide and Beta-cell RepAir (LIBRA) Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Liraglutide Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Liraglutide

U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:

Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2) [ Time Frame: 48-weeks ] [ Designated as safety issue: No ]
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:

Glycemic Control [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- 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

Enrollment:	63
Study Start Date:	January 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Liraglutide	Drug: Liraglutide Liraglutide administered as once daily sc injection Other Name: Victoza
Placebo Comparator: Placebo	Drug: placebo placebo administered as once daily sc injection

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.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270789

Locations

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5

Sponsors and Collaborators

Mount Sinai Hospital, Canada

Novo Nordisk

Investigators

Principal Investigator:

Ravi Retnakaran, MD

Mount Sinai Hospital, New York

More Information

No publications provided

Responsible Party:	Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:	NCT01270789 History of Changes
Other Study ID Numbers:	10-0230-A
Study First Received:	January 4, 2011
Last Updated:	April 8, 2013
Health Authority:	Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:

beta-cell function
GLP-1 analogue
diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1

Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013