Liraglutide Use in Prader-Willi Syndrome

December 8, 2015 updated by: David E. Harris, MD, Vancouver General Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital - Diamond Center

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

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liraglutide
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome
Drug: Liraglutide
Liraglutide 0.6 mg SQ daily for one week, increase to a maximum dose of 1.8 mg SQ daily by 6 weeks, and subsequent continuation for the remainder of a year.
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1C
Time Frame: Change from baseline in A1C at 12 months
Change from baseline in A1C at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Blood Glucose (mmol/L)
Time Frame: Change from baseline in fasting blood glucose at 12 months
Change from baseline in fasting blood glucose at 12 months
Fasting Blood Insulin level
Time Frame: Change from baseline in fasting blood insulin at 12 months
Change from baseline in fasting blood insulin at 12 months
Body Weight (kg)
Time Frame: Change from baseline in body weight at 12 months
Change from baseline in body weight at 12 months
Fasting Lipid Profile
Time Frame: Change from baseline in fasting lipid profile at 12 months
Change from baseline in fasting lipid profile at 12 months
Hip Circumference (cm)
Time Frame: Change from baseline in hip circumference at 12 months
Change from baseline in hip circumference at 12 months
Total Body Adipose Tissue Distribution (whole body Computed Tomography)
Time Frame: Change from baseline in total body adipose tissue distribution at 12 months
Change from baseline in total body adipose tissue distribution at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vancouver General Hospital

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Jason Kong, MD, FRCPC, Vancouver General Hospital, University of British Columbia

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

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

February 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (ESTIMATE)

March 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PWS.VGH.UBC

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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