Liraglutide Use in Prader-Willi Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01542242|
Recruitment Status : Terminated (Subject withdrew)
First Posted : March 2, 2012
Last Update Posted : December 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2 Prader Willi Syndrome||Drug: Liraglutide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome
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 Name: Victoza
- Hemoglobin A1C [ Time Frame: Change from baseline in A1C at 12 months ]
- Fasting Blood Glucose (mmol/L) [ Time Frame: 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 ]
- Body Weight (kg) [ Time Frame: Change from baseline in body weight at 12 months ]
- Fasting Lipid Profile [ Time Frame: Change from baseline in fasting lipid profile at 12 months ]
- Hip Circumference (cm) [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542242
|Canada, British Columbia|
|Vancouver General Hospital - Diamond Center|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Jason Kong, MD, FRCPC||Vancouver General Hospital, University of British Columbia|