Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000862640p
Ethics application status
Submitted, not yet approved
Date submitted
19/07/2023
Date registered
11/08/2023
Date last updated
11/08/2023
Date data sharing statement initially provided
11/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of Glucagon-like peptide 1 agonists in dialysis patients
Scientific title
Assessment of the feasibility, safety, tolerability and efficacy of dulaglutide, a glucagon-like peptide-1 receptor agonist in dialysis patients
Secondary ID [1] 310140 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease 330701 0
Diabetes 330702 0
Condition category
Condition code
Renal and Urogenital 327541 327541 0 0
Kidney disease
Metabolic and Endocrine 327542 327542 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study aims to assess the feasibility, safety, tolerability and efficacy of dulaglutide (one type of GLP-receptor agonist) in dialysis patients.

All dialysis patients, including both haemodialysis and peritoneal dialysis under the care of Te Whatu Ora Te Toka Tumai Auckland City Hospital will be screened for diabetes with HbA1c of more than 53mmol/mol, or who are already on anti-diabetic therapies. They will be assessed by the investigators if they fulfil the inclusion criteria. They will then be approached by study investigators to see if they are willing to participate in this trial. If they are willing to participate in the study, they will be given dulaglutide in accordance with recommendations from New Zealand Society of Diabetes.

For the intervention drug, the dose administered is dulaglutide 1.5mg weekly, with duration of treatment for 12 months. This is a subcutaneous injection.

In patients who dialyses in units that can administer subcutaneous medications, this would be administered in the unit when they attend for dialysis. In other patients, they will be asked about adherence during clinic and study visits.
Intervention code [1] 326538 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335395 0
Blood tests will be done to check for glycated haemoglobin (HBA1c)
Timepoint [1] 335395 0
3, 6 and 12 months post intervention commencement
Primary outcome [2] 335396 0
All cause mortality
Timepoint [2] 335396 0
12 months post-intervention commencement
Primary outcome [3] 335397 0
Height will be measured by stadiometer or wall mounted height measure, and weight is measured using balance scales. Body mass index will then be calculated from the height and weight. The changes in body mass index will be measured.
Timepoint [3] 335397 0
3,6 and 12 months post-intervention commencement
Secondary outcome [1] 424345 0
Composite outcome of cardiovascular events, including myocardial infarction, cardiac failure, cerebrovascular events and hospitalizations. The data will be collected through electronic medical records or scanned paper medical records by the investigators or study coordinator.
Timepoint [1] 424345 0
12, 24, 36 months post-intervention commencement
Secondary outcome [2] 424346 0
Blood pressure via sphygmomanometer
Timepoint [2] 424346 0
3,6 and 12 months post-intervention commencement
Secondary outcome [3] 424347 0
Blood tests will be taken, to test for lipid profile, including total cholesterol, HDL, LDL and triglyceride
Timepoint [3] 424347 0
3, 6 and 12 months post-intervention commencement
Secondary outcome [4] 424348 0
Blood test will be taken to check for lipase
Timepoint [4] 424348 0
1, 3, 6 and 12 months post-intervention commencement
Secondary outcome [5] 424349 0
Changes in doses of oral hypoglycaemic, through study specific survey
Timepoint [5] 424349 0
Baseline and 12 months post-intervention commencement
Secondary outcome [6] 424350 0
Ability to stop insulin through study-specific survey
Timepoint [6] 424350 0
12 months post-intervention commencement
Secondary outcome [7] 424351 0
Serious adverse events including severe diarrhoea, pancreatitis, liver dysfunction, new atrial fibrillation, cholecystitis and skin reaction through assessment of electronic medical records or scanned paper medical records
Timepoint [7] 424351 0
throughout study period up to 12 months post-intervention commencement
Secondary outcome [8] 424352 0
Discontinuation rate through audit of study withdrawal logs
Timepoint [8] 424352 0
12 months post-intervention commencement
Secondary outcome [9] 424353 0
Blood test for hypoglycaemia, during each study visit
Timepoint [9] 424353 0
Throughout study period up to 12 months post-intervention commencement
Secondary outcome [10] 424355 0
Quality of life questionnaire with EQ 5D-5L
Timepoint [10] 424355 0
1,6 and 12 months post intervention commencement
Secondary outcome [11] 424356 0
Blood, urine and peritoneal dialysate test to calculate adequacy test for residual renal function in peritoneal dialysis patients
Timepoint [11] 424356 0
6 and 12 months post-intervention commencement
Secondary outcome [12] 424772 0
Changes in doses of insulin doses, through study specific survey
Timepoint [12] 424772 0
Baseline and 12 months post-intervention commencement
Secondary outcome [13] 425104 0
Ability to stop other non insulin diabetes medications through study specific survey
Timepoint [13] 425104 0
12 months post intervention commencement
Secondary outcome [14] 425105 0
Gastrointestinal Symptom Rating Scale
Timepoint [14] 425105 0
At baseline, 1 month, 6 month and 12 month post intervention commencement

Eligibility
Key inclusion criteria
1. Type 2 diabetes.
2. Stable on either haemodialysis, peritoneal dialysis or hybrid therapy (both haemodialysis and peritoneal dialysis) for at least 3 months.
3. Aged 18 years old or older
4. Able to give informed consent.
5. HbA1c >53mmol/mol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Known allergy or adverse drug effect to GLP-1 receptor agonists
2. Known severe hepatic dysfunction such as portal hypertension or cirrhosis, acute or chronic hepatitis, signs or symptoms of other liver disease, or an alanine transaminase (ALT) level >3 times the upper limit of normal
3. Have a past history of acute, chronic or idiopathic pancreatitis
4. Excessive alcohol intake above recommended levels
5. Type 1 diabetes
6. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B
7. Malnutrition
8. Pregnancy
9. Planning for coronary, carotid or peripheral artery revascularisation
10. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or had undergone gastric bypass (bariatric) surgery
11. Acute coronary syndrome or cerebrovascular event within 14 days prior to screening
12. In the judgement of the investigator, have any other condition that is likely to limit protocol compliance or reporting of adverse events

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
95
Accrual to date
Final
Recruitment outside Australia
Country [1] 25647 0
New Zealand
State/province [1] 25647 0
Auckland

Funding & Sponsors
Funding source category [1] 314300 0
Charities/Societies/Foundations
Name [1] 314300 0
Auckland Hospitals Research and Endowment Fund (AHREF),
Country [1] 314300 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Auckland City Hospital
2 Park Road
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 316244 0
None
Name [1] 316244 0
Address [1] 316244 0
Country [1] 316244 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313413 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 313413 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 313413 0
New Zealand
Date submitted for ethics approval [1] 313413 0
17/07/2023
Approval date [1] 313413 0
Ethics approval number [1] 313413 0

Summary
Brief summary
Background:
Glucagon-like peptide 1 (GLP-1) receptor agonists are incretin-mimetic agents that are increasingly used in diabetes. The benefits of this class of medications include improvement in glycaemic control, weight loss, modifying cardiovascular risk. Patients with end stage renal disease (ESRD) on dialysis are largely excluded from the seminal large, randomized trials. Cardiovascular disease remains the main cause of mortality and morbidity in patients with ESRD. This study aims to investigate the safety, efficacy and feasibility of investigating GLP-1 agonists in dialysis patients.

Aims
This pilot study aims to assess the feasibility, safety, tolerability and efficacy of dulaglutide (one type of GLP-receptor agonist) in dialysis patients.

Hypothesis
It is feasible and safe to use dulaglutide in dialysis patients with diabetes. This will lead to improvement in HbA1c, weight and cardiovascular outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128070 0
Dr Tze Liang Goh
Address 128070 0
Renal Department
Auckland City Hospital
2 Park Road
Auckland 1023
Country 128070 0
New Zealand
Phone 128070 0
+64 93074949
Fax 128070 0
Email 128070 0
goht@adhb.govt.nz
Contact person for public queries
Name 128071 0
Dr Tze Liang Goh
Address 128071 0
Renal Department
Auckland City Hospital
2 Park Road
Auckland 1023
Country 128071 0
New Zealand
Phone 128071 0
+64 3074949
Fax 128071 0
Email 128071 0
goht@adhb.govt.nz
Contact person for scientific queries
Name 128072 0
Dr Tze Liang Goh
Address 128072 0
Renal Department
Auckland City Hospital
2 Park Road
Auckland 1023
Country 128072 0
New Zealand
Phone 128072 0
+64 93074949
Fax 128072 0
Email 128072 0
goht@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.