LIraglutide and Beta-cell RepAir (LIBRA) Study

Type 2 Diabetes Clinical Trial

— LIBRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270789
• Other study ID #: 10-0230-A
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2011
• Last updated: September 10, 2014
• Start date: January 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Liraglutide
Liraglutide administered as once daily sc injection
• placebo
placebo administered as once daily sc injection

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48-weeks	No
Secondary	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	48 weeks	No