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Trial registered on ANZCTR
Registration number
ACTRN12612000352808
Ethics application status
Approved
Date submitted
26/03/2012
Date registered
27/03/2012
Date last updated
14/08/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigation of whether metformin can be used safely and effectively in patients with type 2 diabetes on haemodialysis
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Scientific title
A short term study of safety and glycaemic outcomes in haemodialysis patients with type 2 diabetes treated with metformin
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Secondary ID [1]
280222
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Nil
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Universal Trial Number (UTN)
U1111-1129-4788
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Chronic Renal failure on haemodialysis
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Condition category
Condition code
Metabolic and Endocrine
286361
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0
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Diabetes
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Renal and Urogenital
286362
286362
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Metformin dosed orally at 500mg within one hour post each haemodialysis session for 3 weeks (after 9 dialysis sessions)
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Intervention code [1]
284552
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Treatment: Drugs
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Comparator / control treatment
Own controls- assessed off drug initially
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Establishing a safe dosing regimen for metformin in patients on haemodialysis based on pharmacokinetic data collected after metformin is dosed.
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Assessment method [1]
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Timepoint [1]
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Dialysis cycles 1,2, 3: Metformin concentrations and bicarbonate, lactate and pH measured at 120 min, 240min post metformin dose and the next morning, then prior to and post dialysis.
Dialysis cycles 4,5, 6,7,8: Metformin concentrations pre and post dialysis. Lactate, pH and Bicarbonate concentrations pre dialysis on cycle 6.
Dialysis cycle 9: Metformin concentrations pre dialysis and post dialysis at 120 min, 240min post metformin dose and the next morning, along with measurement of bicarbonate, lactate and pH.
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Secondary outcome [1]
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To describe the effects of metformin on diabetes control in patients with type 2 diabetes treated with haemodialysis -Metformin effect will be assessed by change in insulin sensitivity by the Homeostasis Model Assessment (HOMA2) and by change in average blood glucose measured by continutous glucose monitoring (CGMS).
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Assessment method [1]
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Timepoint [1]
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Baseline and at 4 weeks for a 72 hour period each time
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Eligibility
Key inclusion criteria
> 18 years
Type 2 Diabetes
Receiving haemodialysis 3 times a week for greater than 3 months
Patients in which metformin would normally be used if they had normal renal function.
Consent
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1)Any patients in whom metformin would not be used in the setting of normal renal function including: Moderate to severe heart failure, liver failure, alcohol abuse, major psychiatric disorder, acutely unwell or otherwise medically unstable.
(2)Unable or unwilling to self monitor and record blood glucose levels via glucometer readings.
(3)Inability to provide written informed consent.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Pharmacokinetics / pharmacodynamics
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/04/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Department Clinical Pharmacology ,Flinders Medical Centre
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Address [1]
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Flinders Dr,
Bedford Park
SA 5042
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Tilenka Thynne
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Address
Flinders Dr,
Bedford Park
SA 5042
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Matthew Doogue
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Address [1]
283840
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Flinders Dr,
Bedford Park
SA 5042
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Country [1]
283840
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
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Ethics committee address [1]
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Flinders Dr,
Bedford Park
SA 5042
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/03/2012
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Approval date [1]
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04/04/2012
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Ethics approval number [1]
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EC00188
Application Number: 324.11
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Summary
Brief summary
This is a study aiming to evaluate whether metformin, an antidiabetic medication, can be used safety and effectively in patients with type 2 diabetes who are receiving haemodialysis for their end stage kidney disease. The study runs over 4 weeks and 500mg of metformin (one tablet) will be given to participants after each dialysis session in weeks 2-4 of the study (9 times).
We hypothesise that metformin can be safely used in patients with type 2 diabetes with end stage renal failure if dosed based on predicted drug clearance.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
33979
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Contact person for public queries
Name
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Dr Tilenka Thynne
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Address
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Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Dr,
Bedford Park
SA 5042
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Country
17226
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Australia
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Phone
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+61 8 82045511
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Matthew Doogue
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Address
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Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Dr,
Bedford Park
SA 5042
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Country
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Australia
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Phone
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+61 8 82045511
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Fax
8154
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
The pharmacokinetics of metformin in patients receiving intermittent haemodialysis.
2020
https://dx.doi.org/10.1111/bcp.14244
N.B. These documents automatically identified may not have been verified by the study sponsor.
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