Liraglutide Use in Prader-Willi Syndrome

Diabetes Mellitus Type 2 Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01542242
• Other study ID #: PWS.VGH.UBC
• Status: Terminated
• Phase: Phase 4
• First received: February 21, 2012
• Last updated: December 8, 2015
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2015
• Source: Vancouver General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Prader Willi Syndrome
• Prader-Willi Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital - Diamond Center	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Vancouver General Hospital	Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C		Change from baseline in A1C at 12 months	No
Secondary	Fasting Blood Glucose (mmol/L)		Change from baseline in fasting blood glucose at 12 months	No
Secondary	Fasting Blood Insulin level		Change from baseline in fasting blood insulin at 12 months	No
Secondary	Body Weight (kg)		Change from baseline in body weight at 12 months	No
Secondary	Fasting Lipid Profile		Change from baseline in fasting lipid profile at 12 months	No
Secondary	Hip Circumference (cm)		Change from baseline in hip circumference at 12 months	No
Secondary	Total Body Adipose Tissue Distribution (whole body Computed Tomography)		Change from baseline in total body adipose tissue distribution at 12 months	No