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Liraglutide Use in Prader-Willi Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novo Nordisk
Information provided by (Responsible Party):
David E. Harris, MD, Vancouver General Hospital
ClinicalTrials.gov Identifier:
NCT01542242
First received: February 21, 2012
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Liraglutide
U.S. FDA Resources

Further study details as provided by Vancouver General Hospital:

Primary Outcome Measures:
  • Hemoglobin A1C [ Time Frame: Change from baseline in A1C at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting Blood Glucose (mmol/L) [ Time Frame: Change from baseline in fasting blood glucose at 12 months ] [ Designated as safety issue: No ]
  • Fasting Blood Insulin level [ Time Frame: Change from baseline in fasting blood insulin at 12 months ] [ Designated as safety issue: No ]
  • Body Weight (kg) [ Time Frame: Change from baseline in body weight at 12 months ] [ Designated as safety issue: No ]
  • Fasting Lipid Profile [ Time Frame: Change from baseline in fasting lipid profile at 12 months ] [ Designated as safety issue: No ]
  • Hip Circumference (cm) [ Time Frame: Change from baseline in hip circumference at 12 months ] [ Designated as safety issue: No ]
  • Total Body Adipose Tissue Distribution (whole body Computed Tomography) [ Time Frame: Change from baseline in total body adipose tissue distribution at 12 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2012
Estimated Study Completion Date: March 2013
Estimated 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

Ages Eligible for Study:   19 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542242

Locations
Canada, British Columbia
Vancouver General Hospital - Diamond Center
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver General Hospital
Novo Nordisk
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
Study First Received: February 21, 2012
Last Updated: February 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by Vancouver General Hospital:
Diabetes Mellitus Type 2
Prader Willi Syndrome

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prader-Willi Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
 Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013