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Trial registered on ANZCTR


Registration number
ACTRN12611000908932
Ethics application status
Approved
Date submitted
24/08/2011
Date registered
24/08/2011
Date last updated
24/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of factors affecting the concentrations of metformin in type 2 diabetic patients
Scientific title
The clinical pharmacokinetics of metformin in patients with type 2 diabetes
Secondary ID [1] 262914 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 270642 0
Condition category
Condition code
Metabolic and Endocrine 270814 270814 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study involves recruiting patients who are taking metformin for their type 2 diabetes. Patients 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 and lactic acid concentration.
Intervention code [1] 269267 0
Not applicable
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279509 0
To investigate the pharmacokinetics of metformin in patients with type 2 diabetes by developing a population pharmacokinetic model.
Timepoint [1] 279509 0
Metformin concentrations at different occasions within a patient for intra-patient variability and metformin concentrations between patients to examine inter-patient variability. The number of metformin concentrations is not fixed, therefore can range from 1 to 6.
Secondary outcome [1] 287769 0
To investigate factors influencing the pharmacokinetics of metformin between patients. This includes the influence of kidney function (creatinine clearance), body size descriptors (weight), age and genetic polymorphisms of transporters involved in the uptake of metformin.
Timepoint [1] 287769 0
At the first instance for each patient.

Eligibility
Key inclusion criteria
Patients with type 2 diabetes and taking metformin.
Minimum age
18 Years
Maximum age
100 Years
Gender
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
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269731 0
Government body
Name [1] 269731 0
ARC Linkage Grant
Address [1] 269731 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA
Country [1] 269731 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] 268773 0
None
Name [1] 268773 0
Address [1] 268773 0
Country [1] 268773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271699 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 271699 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 271699 0
Australia
Date submitted for ethics approval [1] 271699 0
Approval date [1] 271699 0
06/05/2008
Ethics approval number [1] 271699 0
1/08/0035

Summary
Brief summary
This study investigates the use of metformin in patients with type 2 diabetes with an aim to develop a population pharmacokinetic model to describe the pharmacokinetics. It involves obtaining a medical history of the patient and asking patients about their metformin formulation, dose, dosing times and their compliance to the medication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33072 0
Address 33072 0
Country 33072 0
Phone 33072 0
Fax 33072 0
Email 33072 0
Contact person for public queries
Name 16319 0
Janna Duong
Address 16319 0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 16319 0
Australia
Phone 16319 0
+61 2 8382 2309
Fax 16319 0
+61 2 8382 2724
Email 16319 0
janna.duong@unsw.edu.au
Contact person for scientific queries
Name 7247 0
Prof Richard Day
Address 7247 0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 7247 0
Australia
Phone 7247 0
+61 2 8382 2304
Fax 7247 0
Email 7247 0
r.day@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary