Liraglutide Use in Prader-Willi Syndrome

Sponsor
Vancouver General Hospital
Study ID
NCT01542242
Phase
PHASE4
Status
Terminated

Conditions

  • Diabetes Mellitus Type 2
  • Prader Willi Syndrome

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Liraglutide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
Dec 2015
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Hemoglobin A1C [ Time Frame: Change from baseline in A1C at 12 months ]

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