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Trial registered on ANZCTR


Registration number
ACTRN12612000864820
Ethics application status
Not yet submitted
Date submitted
14/08/2012
Date registered
15/08/2012
Date last updated
15/08/2012
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 peritoneal dialysis
Scientific title
A short term study of safety and glycaemic outcomes in peritoneal dialysis patients with type 2 diabetes treated with metformin
Secondary ID [1] 281030 0
nil
Universal Trial Number (UTN)
U1111-1133-4789
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 287166 0
Chronic kidney Disease- on peritoneal dialysis 287167 0
Condition category
Condition code
Metabolic and Endocrine 287490 287490 0 0
Diabetes
Renal and Urogenital 287491 287491 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin 250 mg orally (half a 500mg tablet once a day) for 4 weeks of active treatment while continuing participants' existing peritoneal dialysis treatment. Peritoneal dialysis is not standardised
Intervention code [1] 285490 0
Treatment: Drugs
Comparator / control treatment
Own control- participants will have baseline glycaemic measures (via HbA1c and via the continuous blood glucose monitoring and via measures of insulin sensitivity) prior to treatment and be used as their own comparator for repeat testing after 4 weeks of metformin therapy.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287746 0
Pharmacokinetics of metformin in the setting of peritoneal dialysis
Timepoint [1] 287746 0
Metformin plasma concentrations matched with metformin peritoneal dialysis concentrations hourly 1-6 hours post first dose and post last dose at steady state (4 weeks later). In between trough metformin concentrations (plasma and peritoneal dialysis fluid and urine) weekly.
Primary outcome [2] 287747 0
Safety of metformin in peritoneal dialysis
Timepoint [2] 287747 0
Baseline and weekly lactate, bicarbonate and pH concentrations.
Secondary outcome [1] 298769 0
To describe the pharmacodynamic effects of metformin in patients on peritoneal dialysis treated with metformin- evaluating insulin sensitivity pre and post treatment and blood glucose concentrations
Timepoint [1] 298769 0
Continous blood glucose monitor worn for 72 hours in the week prior and the final week of treatment.
Own blood glucose concentrations 3-4 times a day.
Fasting glucose and insulin for Homeostasis Model Assessment (HOMA2) of insulin sensitivity pre treatment and final week of treatment.

Eligibility
Key inclusion criteria
(1)>18 years old
(2)Type 2 DM
(3)Peritoneal Dialysis treatment of chronic kidney disease
(4)Patients in whom metformin would be used if they had normal renal function
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1)Any patient in whom metofrmin would not be used in the setting of normal renal function- moderate-severe heart failure, liver failure, alcohol abuse, major psychaitric disorder, acutely unwell or otherwise medically unstable.
(2)Unability or unwilling to measure own blood glucose concentrations via glucometer.
(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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
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] 285815 0
Hospital
Name [1] 285815 0
Department Clinical Pharmacology ,Flinders Medical Centre
Country [1] 285815 0
Australia
Primary sponsor type
Individual
Name
Tilenka Thynne
Address
Department Clinical Pharmacology ,Flinders Medical Centre
Flinders Dr,
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 284640 0
Individual
Name [1] 284640 0
Dr Matthew Doogue
Address [1] 284640 0
Flinders Dr,
Bedford Park
SA 5042
Country [1] 284640 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287828 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 287828 0
Flinders Dr,
Bedford Park
SA 5042
Ethics committee country [1] 287828 0
Australia
Date submitted for ethics approval [1] 287828 0
16/08/2012
Approval date [1] 287828 0
Ethics approval number [1] 287828 0

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 peritoneal dialysis for their end stage kidney disease. The study runs over 4 weeks of active treatment, 250mg of metformin daily orally.
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 34579 0
Address 34579 0
Country 34579 0
Phone 34579 0
Fax 34579 0
Email 34579 0
Contact person for public queries
Name 17826 0
Dr Tilenka Thynne
Address 17826 0
Department of Clinical Pharmacology
Flinders Dr,
Bedford Park
SA 5042
Country 17826 0
Australia
Phone 17826 0
+61 8 82045511
Fax 17826 0
Email 17826 0
[email protected]
Contact person for scientific queries
Name 8754 0
Dr Matthew Doogue
Address 8754 0
Department of Clinical Pharmacology
Flinders Dr,
Bedford Park
SA 5042
Country 8754 0
Australia
Phone 8754 0
+61 8 82045511
Fax 8754 0
Email 8754 0
[email protected]

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

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