Liraglutide Use in Prader-Willi Syndrome

NCT ID: NCT01542242

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus Type 2 Prader Willi Syndrome

Keywords

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Diabetes Mellitus Type 2 Prader Willi Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide

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

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role lead

Responsible Party

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David E. Harris, MD

MD, Clinical Endocrinology Fellow, University of British Columbia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Kong, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Vancouver General Hospital, University of British Columbia

Locations

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Vancouver General Hospital - Diamond Center

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 21388446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21632815 (View on PubMed)

Other Identifiers

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PWS.VGH.UBC

Identifier Type: -

Identifier Source: org_study_id