NCT01542242

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

February 21, 2012

Last Update Submit

December 8, 2015

Conditions

Diabetes Mellitus Type 2Prader Willi Syndrome

Keywords

Diabetes Mellitus Type 2Prader Willi Syndrome

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C

    Change from baseline in A1C at 12 months

Secondary Outcomes (6)

  • Fasting Blood Glucose (mmol/L)

    Change from baseline in fasting blood glucose at 12 months

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Liraglutide

EXPERIMENTAL

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

Drug: Liraglutide

Interventions

LiraglutideDRUG

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.

Also known as: Victoza
Liraglutide

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prader Willi Syndrome, Diabetes Type 2

You may not qualify if:

  • Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome.
  • Subjects with acute or chronic Pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital - Diamond Center

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related 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. No abstract available.

    PMID: 21388446BACKGROUND

  • 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.

    PMID: 21632815BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prader-Willi Syndrome

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting DisordersObesityOverweightOvernutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Jason Kong, MD, FRCPC

    Vancouver General Hospital, University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Clinical Endocrinology Fellow, University of British Columbia

Study Record Dates

First Submitted

February 21, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

CA(1)