Back to resultsLiraglutide Use in Prader-Willi Syndrome
Primary Purpose
Diabetes Mellitus Type 2, Prader Willi Syndrome
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Diabetes Mellitus Type 2, Prader Willi Syndrome
Eligibility Criteria
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
Sites / Locations
- Vancouver General Hospital - Diamond Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liraglutide
Arm Description
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome
Outcomes
Primary Outcome Measures
Hemoglobin A1C
Secondary Outcome Measures
Fasting Blood Glucose (mmol/L)
Fasting Blood Insulin level
Body Weight (kg)
Fasting Lipid Profile
Hip Circumference (cm)
Total Body Adipose Tissue Distribution (whole body Computed Tomography)
Full Information
NCT ID
NCT01542242
First Posted
February 21, 2012
Last Updated
December 8, 2015
Sponsor
Vancouver General Hospital
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT01542242
Brief Title
Liraglutide Use in Prader-Willi Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Subject withdrew
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vancouver General Hospital
Collaborators
Novo Nordisk A/S
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Prader Willi Syndrome
Keywords
Diabetes Mellitus Type 2, Prader Willi Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Time Frame
Change from baseline in A1C at 12 months
Secondary Outcome Measure Information:
Title
Fasting Blood Glucose (mmol/L)
Time Frame
Change from baseline in fasting blood glucose at 12 months
Title
Fasting Blood Insulin level
Time Frame
Change from baseline in fasting blood insulin at 12 months
Title
Body Weight (kg)
Time Frame
Change from baseline in body weight at 12 months
Title
Fasting Lipid Profile
Time Frame
Change from baseline in fasting lipid profile at 12 months
Title
Hip Circumference (cm)
Time Frame
Change from baseline in hip circumference at 12 months
Title
Total Body Adipose Tissue Distribution (whole body Computed Tomography)
Time Frame
Change from baseline in total body adipose tissue distribution at 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Kong, MD, FRCPC
Organizational Affiliation
Vancouver General Hospital, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital - Diamond Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21388446
Citation
Cyganek K, Koblik T, Kozek E, Wojcik M, Starzyk J, Malecki MT. Liraglutide therapy in Prader-Willi syndrome. Diabet Med. 2011 Jun;28(6):755-6. doi: 10.1111/j.1464-5491.2011.03280.x. No abstract available.
Results Reference
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PubMed Identifier
21632815
Citation
Sze L, Purtell L, Jenkins A, Loughnan G, Smith E, Herzog H, Sainsbury A, Steinbeck K, Campbell LV, Viardot A. Effects of a single dose of exenatide on appetite, gut hormones, and glucose homeostasis in adults with Prader-Willi syndrome. J Clin Endocrinol Metab. 2011 Aug;96(8):E1314-9. doi: 10.1210/jc.2011-0038. Epub 2011 Jun 1.
Results Reference
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Learn more about this trial
Liraglutide Use in Prader-Willi Syndrome
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