Trial Review

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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
Scientific title
A short term study of safety and glycaemic outcomes in haemodialysis patients with type 2 diabetes treated with metformin
Secondary ID [1] 280222 0
Nil
Universal Trial Number (UTN)
U1111-1129-4788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 286178 0
Chronic Renal failure on haemodialysis 286179 0
Condition category
Condition code
Metabolic and Endocrine 286361 286361 0 0
Diabetes
Renal and Urogenital 286362 286362 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin dosed orally at 500mg within one hour post each haemodialysis session for 3 weeks (after 9 dialysis sessions)
Intervention code [1] 284552 0
Treatment: Drugs
Comparator / control treatment
Own controls- assessed off drug initially
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286819 0
Establishing a safe dosing regimen for metformin in patients on haemodialysis based on pharmacokinetic data collected after metformin is dosed.
Timepoint [1] 286819 0
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.
Secondary outcome [1] 296731 0
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).
Timepoint [1] 296731 0
Baseline and at 4 weeks for a 72 hour period each time

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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284973 0
Hospital
Name [1] 284973 0
Department Clinical Pharmacology ,Flinders Medical Centre
Country [1] 284973 0
Australia
Primary sponsor type
Individual
Name
Dr Tilenka Thynne
Address
Flinders Dr,
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 283840 0
Individual
Name [1] 283840 0
Dr Matthew Doogue
Address [1] 283840 0
Flinders Dr,
Bedford Park
SA 5042
Country [1] 283840 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286979 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 286979 0
Flinders Dr,
Bedford Park
SA 5042
Ethics committee country [1] 286979 0
Australia
Date submitted for ethics approval [1] 286979 0
26/03/2012
Approval date [1] 286979 0
04/04/2012
Ethics approval number [1] 286979 0
EC00188
Application Number: 324.11

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33979 0
Address 33979 0
Country 33979 0
Phone 33979 0
Fax 33979 0
Email 33979 0
Contact person for public queries
Name 17226 0
Dr Tilenka Thynne
Address 17226 0
Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Dr,
Bedford Park
SA 5042
Country 17226 0
Australia
Phone 17226 0
+61 8 82045511
Fax 17226 0
Email 17226 0
tilenka.thynne@health.sa.gov.au
Contact person for scientific queries
Name 8154 0
Dr Matthew Doogue
Address 8154 0
Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Dr,
Bedford Park
SA 5042
Country 8154 0
Australia
Phone 8154 0
+61 8 82045511
Fax 8154 0
Email 8154 0
matt.doogue@health.sa.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseThe pharmacokinetics of metformin in patients receiving intermittent haemodialysis.2020https://dx.doi.org/10.1111/bcp.14244
N.B. These documents automatically identified may not have been verified by the study sponsor.