Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000135415
Ethics application status
Approved
Date submitted
19/02/2007
Date registered
19/02/2007
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of pioglitazone versus metformin monotherapy in Indigenous Australians with Type 2 Diabetes: effects on metabolic and cardiovascular parameters
Scientific title
Drug naïve Indigenous Australians with Type 2 Diabetes, enrolled in a randomised controlled trial of pioglitazone versus metformin monotherapy to assess the effects on metabolic and cardiovascular parameters
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 1628 0
Condition category
Condition code
Metabolic and Endocrine 1736 1736 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pioglitazone 15mg taken orally (Intervention) once a day for 4weeks if tolerated increased to 15mg oral twice a day taken for 6 months by Indigenous Australians with Type 2 Diabetes
Intervention code [1] 1610 0
Treatment: Drugs
Comparator / control treatment
Metformin 500mg oral (Control) twice a day for 4 weeks if tolerated increased to 1g oral twice a day taken for 6 months by Indigenous Australians with Type 2 Diabetes
Control group
Active

Outcomes
Primary outcome [1] 2413 0
HbA1c values
Timepoint [1] 2413 0
Baseline and at 2, 4 and 6 months after intervention commencement
Primary outcome [2] 2414 0
Weight gain
Timepoint [2] 2414 0
Baseline and at 2, 4 and 6 months after intervention commencement
Primary outcome [3] 2415 0
Weight distribution
Timepoint [3] 2415 0
Baseline and at 2, 4 and 6 months after intervention commencement
Primary outcome [4] 2416 0
Medication side effects
Timepoint [4] 2416 0
Baseline and at 2, 4 and 6 months after intervention commencement
Secondary outcome [1] 4189 0
Medication compliance, side effects, lipids, endothelial dysfunction.
Timepoint [1] 4189 0
2,3,4,5 and 6 months after intervention commencement

Eligibility
Key inclusion criteria
Residential: Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commencesConsent: Participants must be able to give informed voluntary consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women not on a reliable means of contraceptionIndividuals who are unable to give voluntary informed consentIndividual’s permanently living outside of Darwin during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double Blinded Randomised Controlled Trial- Simple randomisation by using a randomisation table created by a computer software (i.e. computerised sequence generation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation by computer-generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and assessors are blinded
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1886 0
Charities/Societies/Foundations
Name [1] 1886 0
Diabetes Australia Research Trust
Country [1] 1886 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Menzies School of Health Research
Address
Menzies School of Health Research
PO Box 41096
CASUARINA NT 0811

Building 58
Royal Darwin Hospital Campus
Rocklands Drive
CASUARINA NT 0810
Country
Australia
Secondary sponsor category [1] 1700 0
None
Name [1] 1700 0
nil
Address [1] 1700 0
Country [1] 1700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3510 0
Human Research Ethics Committee of Northern Territory Department of Health & Community Services and Menzies School of Health Research
Ethics committee address [1] 3510 0
Ethics committee country [1] 3510 0
Australia
Date submitted for ethics approval [1] 3510 0
Approval date [1] 3510 0
Ethics approval number [1] 3510 0
06/29

Summary
Brief summary
This study compares metformin (current first-line medication) to rosiglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of rosiglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropirate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27544 0
Address 27544 0
Country 27544 0
Phone 27544 0
Fax 27544 0
Email 27544 0
Contact person for public queries
Name 10799 0
Mr Suresh Sharma
Address 10799 0
Menzies School of Health Research
PO Box 41096
CASUARINA NT 0811
Building 54
Royal Darwin Hospital Campus
Rocklands Drive
CASUARINA NT 0810
Country 10799 0
Australia
Phone 10799 0
08 8922 8673
Fax 10799 0
0889275187
Email 10799 0
[email protected]
Contact person for scientific queries
Name 1727 0
Dr Louise Maple Brown
Address 1727 0
Menzies School of Health Research
PO Box 41096
CASUARINA NT 0811
Building 54
Royal Darwin Hospital Campus
Rocklands Drive
CASUARINA NT 0810
Country 1727 0
Australia
Phone 1727 0
0889228196
Fax 1727 0
0889275187
Email 1727 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
No additional documents have been identified.