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Liraglutide Use in Prader-Willi Syndrome

NCT01542242 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-12-09

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus Type 2
  • Prader Willi Syndrome

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jason Kong, MD, FRCPC · Vancouver General Hospital, University of British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542242 on ClinicalTrials.gov