Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000935932
Ethics application status
Approved
Date submitted
30/08/2011
Date registered
31/08/2011
Date last updated
31/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical pharmacokinetics of metformin in Australian Aboriginal and Torres Strait Islanders
Scientific title
A study of factors affecting the concentrations of metformin in Australian Aboriginal and Torres Strait Islanders with type 2 diabetes
Secondary ID [1] 262962 0
Nil
Universal Trial Number (UTN)
U1111-1123-9802
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 270685 0
Condition category
Condition code
Metabolic and Endocrine 270859 270859 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Australian Aboriginal patients who are taking metformin for their type 2 diabetes are required to provide a minimum of 1 blood sample and a maximum of 6 blood samples on different occasions. There are no fixed timing period. Blood samples are used to determine metformin concentrations, glycosylated haemoglobin (HbA1c), creatinine, vitamin B12 and lactic acid concentration. The overall duration of this study is 24 months.
Intervention code [1] 269301 0
Not applicable
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279538 0
To investigate whether the pharmacokinetics of metformin is different in Australian Aboriginal and Torres Strait Islander patients compared to non-Indigenous Australians.
Timepoint [1] 279538 0
Data analysis at the end of recruitment.
Secondary outcome [1] 287867 0
To investigate factors influencing the pharmacokinetics of metformin between Australian Aboriginal patients. This includes the influence of kidney function (creatinine clearance), body size descriptors (weight) and age. These factors will be used as covariates in a population pharmacokinetic model to investigate inter-patient variability in metformin pharmacokinetics.
Timepoint [1] 287867 0
At the first instance for each patient.

Eligibility
Key inclusion criteria
Australian Aboriginal or Torres Strait Islander patients with type 2 diabetes and taking metformin.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to provide informed consent to participate in the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4422 0
2036
Recruitment postcode(s) [2] 4423 0
4870

Funding & Sponsors
Funding source category [1] 269767 0
Government body
Name [1] 269767 0
ARC Linkage Grant
Country [1] 269767 0
Australia
Primary sponsor type
Individual
Name
Prof Richard Day
Address
Dept of Clinical Pharmacology and Toxicology
Level 2, St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 268808 0
None
Name [1] 268808 0
Address [1] 268808 0
Country [1] 268808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271724 0
Aboriginal Health and Medical Research Council (AH&MRC) Ethics Committee
Ethics committee address [1] 271724 0
Ethics committee country [1] 271724 0
Australia
Date submitted for ethics approval [1] 271724 0
Approval date [1] 271724 0
27/05/2011
Ethics approval number [1] 271724 0
1/11/0785
Ethics committee name [2] 271725 0
Cairns Base Hospital HREC
Ethics committee address [2] 271725 0
Ethics committee country [2] 271725 0
Australia
Date submitted for ethics approval [2] 271725 0
Approval date [2] 271725 0
09/05/2011
Ethics approval number [2] 271725 0
HREC/11/QCH/33-727

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33095 0
Address 33095 0
Country 33095 0
Phone 33095 0
Fax 33095 0
Email 33095 0
Contact person for public queries
Name 16342 0
Janna Duong
Address 16342 0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 16342 0
Australia
Phone 16342 0
+61 2 8382 2309
Fax 16342 0
Email 16342 0
[email protected]
Contact person for scientific queries
Name 7270 0
Prof Richard Day
Address 7270 0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 7270 0
Australia
Phone 7270 0
+61 2 8382 2304
Fax 7270 0
Email 7270 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe pharmacokinetics of metformin and concentrations of haemoglobin A1C and lactate in Indigenous and non-Indigenous Australians with type 2 diabetes mellitus.2015https://dx.doi.org/10.1111/bcp.12525
N.B. These documents automatically identified may not have been verified by the study sponsor.