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Liraglutide Use in Prader-Willi Syndrome

This study has been terminated.
(Subject withdrew)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542242
First Posted: March 2, 2012
Last Update Posted: December 9, 2015
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.
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
David E. Harris, MD, Vancouver General Hospital
  Purpose

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 Intervention Phase
Diabetes Mellitus Type 2 Prader Willi Syndrome Drug: Liraglutide Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by David E. Harris, MD, Vancouver General Hospital:

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: Change from baseline in A1C at 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome
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.
Other Name: Victoza

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Canada, British Columbia
Vancouver General Hospital - Diamond Center
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver General Hospital
Novo Nordisk A/S
Investigators
Principal Investigator: Jason Kong, MD, FRCPC Vancouver General Hospital, University of British Columbia
  More Information

Publications:
Responsible Party: David E. Harris, MD, MD, Clinical Endocrinology Fellow, University of British Columbia, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT01542242     History of Changes
Other Study ID Numbers: PWS.VGH.UBC
First Submitted: February 21, 2012
First Posted: March 2, 2012
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by David E. Harris, MD, Vancouver General Hospital:
Diabetes Mellitus Type 2
Prader Willi Syndrome

Additional relevant MeSH terms:
Syndrome
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prader-Willi Syndrome
Disease
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists