- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270789
LIraglutide and Beta-cell RepAir (LIBRA) Study (LIBRA)
September 10, 2014 updated by: Mount Sinai Hospital, Canada
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
placebo administered as once daily sc injection
|
Experimental: Liraglutide
|
Liraglutide administered as once daily sc injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)
Time Frame: 48-weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control
Time Frame: 48 weeks
|
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ravi Retnakaran, MD, Mount Sinai Hospital, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stein CM, Kramer CK, Zinman B, Choi H, Opsteen C, Retnakaran R. Clinical predictors and time course of the improvement in beta-cell function with short-term intensive insulin therapy in patients with Type 2 diabetes. Diabet Med. 2015 May;32(5):645-52. doi: 10.1111/dme.12671. Epub 2015 Jan 7.
- Nunez Lopez YO, Retnakaran R, Zinman B, Pratley RE, Seyhan AA. Predicting and understanding the response to short-term intensive insulin therapy in people with early type 2 diabetes. Mol Metab. 2019 Feb;20:63-78. doi: 10.1016/j.molmet.2018.11.003. Epub 2018 Nov 16.
- Kramer CK, Zinman B, Choi H, Connelly PW, Retnakaran R. Impact of the Glucagon Assay When Assessing the Effect of Chronic Liraglutide Therapy on Glucagon Secretion. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2729-2733. doi: 10.1210/jc.2017-00928.
- Kramer CK, Zinman B, Choi H, Retnakaran R. Predictors of sustained drug-free diabetes remission over 48 weeks following short-term intensive insulin therapy in early type 2 diabetes. BMJ Open Diabetes Res Care. 2016 Aug 1;4(1):e000270. doi: 10.1136/bmjdrc-2016-000270. eCollection 2016.
- Kramer CK, Zinman B, Choi H, Connelly PW, Retnakaran R. The Impact of Chronic Liraglutide Therapy on Glucagon Secretion in Type 2 Diabetes: Insight From the LIBRA Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3702-9. doi: 10.1210/jc.2015-2725. Epub 2015 Jul 31.
- Kramer CK, Zinman B, Choi H, Retnakaran R. Effect of Short-term Intensive Insulin Therapy on Post-challenge Hyperglucagonemia in Early Type 2 Diabetes. J Clin Endocrinol Metab. 2015 Aug;100(8):2987-95. doi: 10.1210/jc.2015-1947. Epub 2015 Jun 16.
- Retnakaran R, Kramer CK, Choi H, Swaminathan B, Zinman B. Liraglutide and the preservation of pancreatic beta-cell function in early type 2 diabetes: the LIBRA trial. Diabetes Care. 2014 Dec;37(12):3270-8. doi: 10.2337/dc14-0893. Epub 2014 Sep 23.
- Kramer CK, Choi H, Zinman B, Retnakaran R. Glycemic variability in patients with early type 2 diabetes: the impact of improvement in beta-cell function. Diabetes Care. 2014 Apr;37(4):1116-23. doi: 10.2337/dc13-2591. Epub 2014 Feb 18.
- Kramer CK, Choi H, Zinman B, Retnakaran R. Determinants of reversibility of beta-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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
January 4, 2011
First Submitted That Met QC Criteria
January 4, 2011
First Posted (Estimate)
January 5, 2011
Study Record Updates
Last Update Posted (Estimate)
September 12, 2014
Last Update Submitted That Met QC Criteria
September 10, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-0230-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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