Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00749047




Registration number
NCT00749047
Ethics application status
Date submitted
8/09/2008
Date registered
9/09/2008
Date last updated
16/09/2009

Titles & IDs
Public title
How Does the Diabetes Drug, Pioglitazone, Reduce Protein Loss in the Urine?
Scientific title
A Study on the Anti-proteinuric Effects of Pioglitazone in Patients With Type 2 Diabetes.
Secondary ID [1] 0 0
H6E-AY-O017
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pioglitazone

Experimental: 1 - Open label arm


Treatment: Drugs: Pioglitazone
15-45 mg/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in proteinuria
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Reduction in non-fasting plasma glucose concentration
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
* Diabetes mellitus, Type 2
* Age 18-70 yrs
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Overt proteinuria (urine albumin:creatinine ratio >10.0
* Plasma creatinine 0.15 mmol/L
* HbA1c >10%
* Hear failure Class III or IV
* Peripheral oedema
* Abnormal liver function (serum AST >2.5 times upper limit of normal)
* Pregnancy or breastfeeding
* History of urinary tract infections
* Serious concomitant disorder

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2010
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
Christchurch Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00749047