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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

Key inclusion criteria
- Diabetes mellitus, Type 2

- Age 18-70 yrs
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
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
Basic Science
Allocation to intervention
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 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Christchurch Hospital

Ethics approval
Ethics application status

Brief summary
Pioglitazone is an insulin sensitising drug used in the treatment of patients with type 2
diabetes. In addition to its blood sugar lowering effect, pioglitazone also has a number of
other beneficial effects, one of which is to reduce the loss of protein in the urine. The
mechanism of this protein "sparing effect" of pioglitazone is not fully understood. The
proposed study will investigate whether pioglitazone has beneficial effects on the filtration
characteristics of filters in the kidney that are responsible for retaining protein in the
body. The effect of pioglitazone on the size of the pores in the filters and also the
electrostatic charge barriers that surround these pores will be investigated. The clinical
study will involve 12 patients with type 2 diabetes with minimal urine protein loss, taking
low dose pioglitazone for 3 months. Blood and urine samples will be collected at the
beginning, mid point and end of the study and used to measure the concentration of specific
proteins of different size and electrostatic charge. This data will be used to identify and
characterise changes in the filtration properties of the kidney filters during the study.
Trial website
Trial related presentations / publications
Public notes

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 data has been provided for results reporting
Summary results
Not applicable