Liraglutide Use in Prader-Willi Syndrome

Phase 4

Terminated

• Conditions: Diabetes Mellitus Type 2; Prader Willi Syndrome
• Interventions: Drug: Liraglutide

• Registration Number: NCT01542242
• Lead Sponsor: Vancouver General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liraglutide	Liraglutide	Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	Change from baseline in A1C at 12 months

Secondary Outcome Measures

Name	Time	Method
Fasting Blood Insulin level	Change from baseline in fasting blood insulin at 12 months
Body Weight (kg)	Change from baseline in body weight at 12 months
Fasting Lipid Profile	Change from baseline in fasting lipid profile at 12 months
Hip Circumference (cm)	Change from baseline in hip circumference at 12 months
Fasting Blood Glucose (mmol/L)	Change from baseline in fasting blood glucose at 12 months
Total Body Adipose Tissue Distribution (whole body Computed Tomography)	Change from baseline in total body adipose tissue distribution at 12 months

Trial Locations

Locations (1)

Vancouver General Hospital - Diamond Center; 🇨🇦 Vancouver, British Columbia, Canada