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Trial registered on ANZCTR


Registration number
ACTRN12611000893909
Ethics application status
Approved
Date submitted
22/08/2011
Date registered
22/08/2011
Date last updated
24/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of metformin in diabetic patients with kidney disease
Scientific title
Evaluating the safety and efficacy of metformin in patients with type 2 diabetes and chronic renal impairment
Secondary ID [1] 262890 0
Nil
Universal Trial Number (UTN)
U1111-1123-9802
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney disease 270618 0
Type 2 diabetes 270621 0
Condition category
Condition code
Renal and Urogenital 270785 270785 0 0
Kidney disease
Metabolic and Endocrine 270788 270788 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic renal impairment were administered low dose metformin, 500mg oral capsule daily for 6 weeks. Patients on dialysis were administered metformin at lower doses of 250mg daily for 6 weeks. At least 8 clinic visits were required for routine clinical care, including pathology tests.
Intervention code [1] 269243 0
Treatment: Drugs
Comparator / control treatment
An active control was not used. Patients were compared pre- and post-treatment with metformin.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279482 0
Accumulation of metformin in the body assessed by assaying metformin concentrations in plasma
Timepoint [1] 279482 0
Weekly for 6 weeks.
Secondary outcome [1] 287723 0
Relationship between metformin concentration, glycaemic control and lactate concentration. Glycaemic control is assessed by self-monitored fasting blood sugar levels, fructosamine and HbA1c test.
Timepoint [1] 287723 0
Baseline, and at 6 weeks after intervention

Eligibility
Key inclusion criteria
Kidney disease, type 2 diabetes
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cardiac disease, any hypoxic condition, alcohol abuse, history of lactic acidosis.

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. Patients were screened prior to enrolment to ensure they meet the inclusion criteria and none of the exclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were not randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
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] 269716 0
Government body
Name [1] 269716 0
ARC Linkage Grant
Address [1] 269716 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA
Country [1] 269716 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] 268756 0
None
Name [1] 268756 0
Address [1] 268756 0
Country [1] 268756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271680 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 271680 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 271680 0
Australia
Date submitted for ethics approval [1] 271680 0
Approval date [1] 271680 0
12/08/2009
Ethics approval number [1] 271680 0
1/09/0092

Summary
Brief summary
This is an open-label, fixed regimen clinical study. Enrolled patients were administered low dose metformin (250mg or 500mg) to examine the effect and exposure of metformin in patients with chronic renal impairment. Patients were monitored frequently to ensure metformin concentrations and lactic acid concentrations were not high. The aim of this study is to determine whether metformin can be safely administered to patients with renal impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33057 0
Address 33057 0
Country 33057 0
Phone 33057 0
Fax 33057 0
Email 33057 0
Contact person for public queries
Name 16304 0
Janna Duong
Address 16304 0
Dept of Clinical Pharmacology and Toxicology
Level 2, St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 16304 0
Australia
Phone 16304 0
+61 2 8382 2309
Fax 16304 0
Email 16304 0
janna.duong@unsw.edu.au
Contact person for scientific queries
Name 7232 0
Prof Richard Day
Address 7232 0
Dept of Clinical Pharmacology and Toxicology
Level 2 St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Country 7232 0
Australia
Phone 7232 0
+61 2 8382 2304
Fax 7232 0
Email 7232 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