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LIraglutide and Beta-cell RepAir (LIBRA) Study

This study has been completed.
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: September 10, 2014
Last verified: September 2014

January 4, 2011
September 10, 2014
January 2011
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01270789 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
LIraglutide and Beta-cell RepAir (LIBRA) Study
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Liraglutide
    Liraglutide administered as once daily sc injection
    Other Name: Victoza
  • Drug: placebo
    placebo administered as once daily sc injection
  • Experimental: Liraglutide
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Kramer CK, Choi H, Zinman B, Retnakaran R. Determinants of reversibility of β-cell dysfunction in response to short-term intensive insulin therapy in patients with early type 2 diabetes. Am J Physiol Endocrinol Metab. 2013 Dec 1;305(11):E1398-407. doi: 10.1152/ajpendo.00447.2013. Epub 2013 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01270789
10-0230-A
No
Mount Sinai Hospital, Canada
Mount Sinai Hospital, Canada
Novo Nordisk A/S
Principal Investigator: Ravi Retnakaran, MD Mount Sinai Hospital, Toronto
Mount Sinai Hospital, Canada
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP