LIraglutide and Beta-cell RepAir (LIBRA) Study (LIBRA)
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ClinicalTrials.gov Identifier: NCT01270789 |
Recruitment Status :
Completed
First Posted : January 5, 2011
Last Update Posted : September 12, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: Liraglutide Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- 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.
- Glycemic Control [ Time Frame: 48 weeks ]
- 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

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270789
Canada, Ontario | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G1X5 |
Principal Investigator: | Ravi Retnakaran, MD | Mount Sinai Hospital, Canada |
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 |
First Posted: | January 5, 2011 Key Record Dates |
Last Update Posted: | September 12, 2014 |
Last Verified: | September 2014 |
Keywords provided by Mount Sinai Hospital, Canada:
beta-cell function GLP-1 analogue diabetes |
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |