LIraglutide and Beta-cell RepAir (LIBRA) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01270789
First received: January 4, 2011
Last updated: August 15, 2013
Last verified: July 2013
  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:


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 A/S
Investigators
Principal Investigator: Ravi Retnakaran, MD Mount Sinai Hospital, Toronto
  More Information

No publications provided by Mount Sinai Hospital, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 15, 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 April 16, 2014