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Trial registered on ANZCTR


Registration number
ACTRN12620000627954
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
29/05/2020
Date last updated
29/10/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a GLP-1 agonist in patients with a dual diagnosis of Parkinson's Disease and Type 2 Diabetes Mellitus
Scientific title
The effect of a GLP-1 agonist in patients with a dual diagnosis of Parkinson's Disease and Type 2 Diabetes Mellitus
Secondary ID [1] 301182 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 317328 0
Type 2 Diabetes Mellitus 317483 0
Condition category
Condition code
Neurological 315437 315437 0 0
Parkinson's disease
Metabolic and Endocrine 315584 315584 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is administration of GLP1-agonist Exenatide extended release (Bydureon) 2mg subcutaneously weekly in patients with a dual diagnosis of Parkinson's Disease and Type 2 Diabetes Mellitus. The study intervention will be administered for a total of 12 months. Patients will be monitored for their Parkinson's symptoms and glycemic control at baseline, 3 months, 6 months and 12 months.
Intervention code [1] 317491 0
Treatment: Drugs
Comparator / control treatment
The control group will receive no treatment (ie. their normal treatment regimen will be unaltered). This normal treatment regimen is their prescribed diabetic and Parkinson's drugs recorded at enrolment, as determined by their regular treating GPs and specialists. Patients will be monitored for their Parkinson's symptoms and glycemic control at baseline, 3 months, 6 months and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 323688 0
Change in motor symptoms of Parkinson's disease as determined by OFF-MED UPDRS part 3 scores
Timepoint [1] 323688 0
12 months from baseline (and initial administration of therapy)
Secondary outcome [1] 382587 0
Change in motor symptoms of Parkinson's disease as determined by OFF-MED UPDRS part 3 scores
Timepoint [1] 382587 0
3 months from baseline (and initial administration of therapy)
Secondary outcome [2] 382588 0
Change in motor symptoms of Parkinson's disease as determined by OFF-MED UPDRS part 3 scores
Timepoint [2] 382588 0
6 months from baseline (and initial administration of therapy)
Secondary outcome [3] 382589 0
Change in total OFF-MED UDPRS score
Timepoint [3] 382589 0
12 months from baseline (and initial administration of therapy)
Secondary outcome [4] 382590 0
Change in total OFF-MED UDPRS score
Timepoint [4] 382590 0
6 months from baseline (and initial administration of therapy)
Secondary outcome [5] 382591 0
Change in total OFF-MED UDPRS score
Timepoint [5] 382591 0
3 months from baseline (and initial administration of therapy)
Secondary outcome [6] 382592 0
Change in PDQ39 score
Timepoint [6] 382592 0
12 months from baseline (and initial administration of therapy)
Secondary outcome [7] 382593 0
Change in PDQ39 score
Timepoint [7] 382593 0
6 months from baseline (and initial administration of therapy)
Secondary outcome [8] 382594 0
Change in PDQ39 score
Timepoint [8] 382594 0
3 months from baseline (and initial administration of therapy)

Eligibility
Key inclusion criteria
1. Diagnosis of Parkinson’s disease meeting UK Brain Bank Criteria
2. Diagnosis of Type 2 Diabetes not receiving GLP-1 agonist therapy
3. HbA1c greater than or equal to 7 %
4. Willingness to give written informed consent and willingness to participate to and comply with the study.
5. Patients with cognitive impairment sufficient to impair capacity to provide informed consent are excluded from the study (MMSE<24)
6. Age >45 years
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient incapable of providing informed consent
2. Patients receiving insulin treatment for type 2 diabetes
3. Contraindications to Extended release Exentatide (Bydureon) therapy including: pregnancy, Multiple Endocrine Neoplasia Type 2, Medullary Carcinoma of the thyroid, active Crohn’s disease or Ulcerative colitis, gastritis or severe gastroparesis, pancreatitis and chronic renal impairment with eGFR<30 ml/min

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305632 0
Self funded/Unfunded
Name [1] 305632 0
Unfunded
Address [1] 305632 0
Unfunded
Country [1] 305632 0
Primary sponsor type
Hospital
Name
St Vincent's Health Network
Address
St Vincent's Hospital,
390 Victoria Street,
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 306039 0
None
Name [1] 306039 0
Not applicable
Address [1] 306039 0
Not applicable
Country [1] 306039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305921 0
Nepean Blue Mountains Local Health District Human Research Ethics
Ethics committee address [1] 305921 0
Level 5
South Block
Nepean Hospital
Kingswood NSW 2747
Ethics committee country [1] 305921 0
Australia
Date submitted for ethics approval [1] 305921 0
11/03/2020
Approval date [1] 305921 0
25/05/2020
Ethics approval number [1] 305921 0

Summary
Brief summary
Parkinson’s Disease (PD) is a progressive neurodegenerative condition that is associated with significant morbidity and loss of independence. Currently, there are few avenues of treatment and even the most potent dopamine-replacement therapies, whilst alleviating some cardinal symptoms, do not alter the underlying disease process or interfere with the progression of the disease. This study will address the potential use of GLP-1 agonists, approved for the use of Type 2 Diabetes, as a therapeutic option. Pre-clinical and human studies have been released that show:

(1) The shared mechanism of Parkinson's Disease and Type 2 Diabetes
(2) The neuro-protective effects of GLP-1 agonists in Parkinson's Disease

However, this study will be the first to analyse this effect in patients with a dual diagnosis of Type 2 Diabetes and Parkinson's Disease. A positive outcome from this study has the clinical potential for becoming the basis for a larger scale randomised-control trial and adjusting the existing diabetes management of this patient population. Both disease processes could be targeted with a medication that is already PBS-listed and the standard of care for one.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102070 0
Ms Simran Dahiya
Address 102070 0
Work address: UNSW Medicine, Wallace Wurth Building, UNSW Sydney, 18 High St, Kensington NSW 2052
Country 102070 0
Australia
Phone 102070 0
+61 430044750
Fax 102070 0
Email 102070 0
simrandahiya0710@gmail.com
Contact person for public queries
Name 102071 0
Ms Simran Dahiya
Address 102071 0
Work address: UNSW Medicine, Wallace Wurth Building, UNSW Sydney, 18 High St, Kensington NSW 2052
Country 102071 0
Australia
Phone 102071 0
+61 430044750
Fax 102071 0
Email 102071 0
simrandahiya0710@gmail.com
Contact person for scientific queries
Name 102072 0
Ms Simran Dahiya
Address 102072 0
Work address: UNSW Medicine, Wallace Wurth Building, UNSW Sydney, 18 High St, Kensington NSW 2052
Country 102072 0
Australia
Phone 102072 0
+61 430044750
Fax 102072 0
Email 102072 0
simrandahiya0710@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no current plan to make individual participant data publicly available. Participant data will be coded and re-identifiable. The sample size is small and participants will be recruited from a single site, such that patient confidentiality may be jeopardised by releasing this information.
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7847 0
Study protocol
Citation [1] 7847 0
Link [1] 7847 0
Email [1] 7847 0
Other [1] 7847 0
Type [2] 7848 0
Informed consent form
Citation [2] 7848 0
Link [2] 7848 0
Email [2] 7848 0
Other [2] 7848 0
Summary results
No Results