Diabetes Mellitus Type 2Phase 4NCT01542242
Liraglutide Use in Prader-Willi Syndrome
A Phase 4 study testing Liraglutide in people with Diabetes Mellitus Type 2 and Prader Willi Syndrome, run by Vancouver General Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2, Prader Willi Syndrome
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prader Willi Syndrome, Diabetes Type 2
Who cannot join
- Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome.
- Subjects with acute or chronic Pancreatitis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital - Diamond Center
Vancouver, British Columbia, V5Z 1M9
About this study
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.
- Conditions
- Diabetes Mellitus Type 2, Prader Willi Syndrome
- Being tested
- Liraglutide
- Keywords
- Diabetes Mellitus Type 2, Prader Willi Syndrome
- Medical subject headings
- Diabetes Mellitus, Type 2, Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
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.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Treatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Measured: Change from baseline in A1C at 12 months
Secondary outcomes (6)
Fasting Blood Glucose (mmol/L)
Measured: Change from baseline in fasting blood glucose at 12 months
Fasting Blood Insulin level
Measured: Change from baseline in fasting blood insulin at 12 months
Body Weight (kg)
Measured: Change from baseline in body weight at 12 months
Fasting Lipid Profile
Measured: Change from baseline in fasting lipid profile at 12 months
Hip Circumference (cm)
Measured: Change from baseline in hip circumference at 12 months
Total Body Adipose Tissue Distribution (whole body Computed Tomography)
Measured: Change from baseline in total body adipose tissue distribution at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Subject withdrew
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, David E. Harris, MD, Vancouver General Hospital
- Investigators
- Jason Kong, MD, FRCPC, Principal investigator, Vancouver General Hospital, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542242
- Sponsor's protocol ID
- PWS.VGH.UBC
- Status last verified
- Dec 2015
- First submitted
- 21 Feb 2012
- Last updated
- 9 Dec 2015
- Results posted
- No
Publications
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.
PubMed 21388446Sze 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.
PubMed 21632815
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide Use in Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT01542242
- Acronym / sponsor ID
- PWS.VGH.UBC
- Conditions
- Diabetes Mellitus Type 2, Prader Willi Syndrome
- Keywords
- Diabetes Mellitus Type 2, Prader Willi Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject withdrew
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vancouver General HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: LiraglutideTreatment of Diabetes Mellitus Type 2 with Liraglutide in the setting of Prader Willi Syndrome |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prader Willi Syndrome, Diabetes Type 2
Key exclusion criteria (2 listed)
- Previous or family history of Medullary Carcinoma of the Thyroid or multiple endocrine neoplasia syndrome.
- Subjects with acute or chronic Pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: VictozaLiraglutide 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. | Drug | Liraglutide |
Primary outcome
Hemoglobin A1C
Time frame: Change from baseline in A1C at 12 months
6 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Subject withdrew). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 21388446Cyganek 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.
- Background: PubMed 21632815Sze 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Kong, MD, FRCPC principal investigator
Vancouver General Hospital, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Diabetes Mellitus Type 2 and Prader Willi Syndrome, run by Vancouver General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Subject withdrew). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: Change from baseline in A1C at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542242, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.