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Trial · Interventional

TerminatedPhase 4Registry data

Liraglutide Use in Prader-Willi Syndrome

NCTNCT01542242 (opens ClinicalTrials.gov in a new tab)Other idPWS.VGH.UBC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
1 participants (actual)
Sponsor
Vancouver General Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Canada

Start
Feb 2012
Primary completion
Mar 2013
Completion
Mar 2013
First posted
2 Mar 2012 (estimated)
Last update posted
9 Dec 2015 (estimated)
Conditions
Diabetes Mellitus Type 2 · Prader Willi Syndrome

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 4

    Liraglutide Use in Prader-Willi Syndrome

    NCT01542242

    Feb 2012 to Mar 2013

    Terminated

Registry summary

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

Liraglutide is a glucagon like peptide -1 (GLP-1) agonist, which is approved for use in patients with type 2 diabetes. Studies of liraglutide have shown an appetite suppressive effect and has been associated with weight loss in patients with type 2 diabetes. Liraglutide use in the treatment of PWS is limited to one case report by Cyganek et el (See attached Citation). In this case report, the subject showed improvements in hemoglobin A1c and body weight over 14 weeks. The investigators plan to examine the use of liraglutide in a single subject with Prader Willi Syndrome and type 2 diabetes for one year. The investigators will examine clinical parameters, clinical assessment of hunger, and biochemical markers of diabetes and lipid control.

Interventions

  • LiraglutideDrug

Arms1

  • Experimental

    Liraglutide

    Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Hemoglobin A1C

    Time frame · Change from baseline in A1C at 12 months

Secondary outcomes(6)

  1. Fasting Blood Glucose (mmol/L)

    Time frame · Change from baseline in fasting blood glucose at 12 months

  2. Fasting Blood Insulin level

    Time frame · Change from baseline in fasting blood insulin at 12 months

  3. Body Weight (kg)

    Time frame · Change from baseline in body weight at 12 months

  4. Fasting Lipid Profile

    Time frame · Change from baseline in fasting lipid profile at 12 months

  5. Hip Circumference (cm)

    Time frame · Change from baseline in hip circumference at 12 months

  6. Total Body Adipose Tissue Distribution (whole body Computed Tomography)

    Time frame · Change from baseline in total body adipose tissue distribution at 12 months

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

10 results

Effects of a single dose of exenatide on appetite, gut hormones, and glucose homeostasis in adults with Prader-Willi syndrome.

Sze et al. 2011The Journal of clinical endocrinology and metabolismcited by 44

PMID 21632815DOI 10.1210/jc.2011-0038PUB-21632815

Full text at the publisher10 results
Publisher pageSee results (10)

More studies

1 study on this page

Indexing hint: Case report · 2011

Liraglutide therapy in Prader-Willi syndrome.

Cyganek et al. 2011Diabetic medicine : a journal of the British Diabetic Associationcited by 19

PMID 21388446DOI 10.1111/j.1464-5491.2011.03280.xPUB-21388446

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 19 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Prader Willi Syndrome, Diabetes Type 2 Exclusion Criteria: * Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome. * Subjects with acute or chronic Pancreatitis

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