Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
The clinical pharmacokinetics of metformin in patients with type 2 diabetes
Query!
Secondary ID [1]
262914
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1123-9802
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes
270642
0
Query!
Condition category
Condition code
Metabolic and Endocrine
270814
270814
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
269267
0
Not applicable
Query!
Comparator / control treatment
Not applicable.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
279509
0
To investigate the pharmacokinetics of metformin in patients with type 2 diabetes by developing a population pharmacokinetic model.
Query!
Assessment method [1]
279509
0
Query!
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.
Query!
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.
Query!
Assessment method [1]
287769
0
Query!
Timepoint [1]
287769
0
At the first instance for each patient.
Query!
Eligibility
Key inclusion criteria
Patients with type 2 diabetes and taking metformin.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
100
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patients unable to provide informed consent to participate in the study.
Query!
Study design
Purpose
Natural history
Query!
Duration
Cross-sectional
Query!
Selection
Convenience sample
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
6/05/2008
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
269731
0
Government body
Query!
Name [1]
269731
0
ARC Linkage Grant
Query!
Address [1]
269731
0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA
Query!
Country [1]
269731
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Prof Richard Day
Query!
Address
Dept of Clinical Pharmacology and Toxicology
Level 2, St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Query!
Country
Australia
Query!
Secondary sponsor category [1]
268773
0
None
Query!
Name [1]
268773
0
Query!
Address [1]
268773
0
Query!
Country [1]
268773
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
271699
0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Query!
Ethics committee address [1]
271699
0
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Query!
Ethics committee country [1]
271699
0
Australia
Query!
Date submitted for ethics approval [1]
271699
0
Query!
Approval date [1]
271699
0
06/05/2008
Query!
Ethics approval number [1]
271699
0
1/08/0035
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
33072
0
Query!
Address
33072
0
Query!
Country
33072
0
Query!
Phone
33072
0
Query!
Fax
33072
0
Query!
Email
33072
0
Query!
Contact person for public queries
Name
16319
0
Janna Duong
Query!
Address
16319
0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Query!
Country
16319
0
Australia
Query!
Phone
16319
0
+61 2 8382 2309
Query!
Fax
16319
0
+61 2 8382 2724
Query!
Email
16319
0
[email protected]
Query!
Contact person for scientific queries
Name
7247
0
Prof Richard Day
Query!
Address
7247
0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Query!
Country
7247
0
Australia
Query!
Phone
7247
0
+61 2 8382 2304
Query!
Fax
7247
0
Query!
Email
7247
0
[email protected]
Query!
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
A dosing algorithm for metformin based on the relationships between exposure and renal clearance of metformin in patients with varying degrees of kidney function.
2017
https://dx.doi.org/10.1007/s00228-017-2251-1
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF