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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01542242
Other study ID # PWS.VGH.UBC
Secondary ID
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


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
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