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Trial · Interventional

CompletedPhase 3Registry data

LIraglutide and Beta-cell RepAir (LIBRA) Study

Short name LIBRA

NCTNCT01270789 (opens ClinicalTrials.gov in a new tab)Other id10-0230-A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
63 participants (actual)
Sponsor
Mount Sinai Hospital, Canada · Other
Design
Randomized · Quadruple masking
Countries
1 country

Canada

Start
Jan 2011
Primary completion
Dec 2013
Completion
May 2014
First posted
5 Jan 2011 (estimated)
Last update posted
12 Sept 2014 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 3

    LIBRA

    NCT01270789

    Jan 2011 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)

    Time frame · 48-weeks

    Registry description

    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 outcomes(1)

  1. Glycemic Control

    Time frame · 48 weeks

    Registry description

    * 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

4 results

The Impact of Chronic Liraglutide Therapy on Glucagon Secretion in Type 2 Diabetes: Insight From the LIBRA Trial.

Kramer et al. 2015The Journal of clinical endocrinology and metabolismcited by 41

PMID 26230296DOI 10.1210/jc.2015-2725PUB-26230296

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2014

5 results

Liraglutide and the preservation of pancreatic β-cell function in early type 2 diabetes: the LIBRA trial.

Retnakaran et al. 2014Diabetes carecited by 101

PMID 25249651DOI 10.2337/dc14-0893PUB-25249651

Full text at the publisher5 results
Publisher pageSee results (5)

More studies

1 study on this page

PubMed tag: none · 2017

Impact of the Glucagon Assay When Assessing the Effect of Chronic Liraglutide Therapy on Glucagon Secretion.

Kramer et al. 2017The Journal of clinical endocrinology and metabolismcited by 14

PMID 28472325DOI 10.1210/jc.2017-00928PUB-28472325

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedNunez 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. PMID 30503831
  • DerivedKramer 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. PMID 27547422
  • DerivedKramer 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. PMID 26079776
  • DerivedStein 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. PMID 25495067
  • DerivedKramer 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. PMID 24550219
  • DerivedKramer 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. PMID 24129396

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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