Type 2 DiabetesNCT00364988
Pioglitazone and Losartan Provides Additional Renoprotection
A study testing pioglitazone+losartan and losartan in people with Type 2 Diabetes and Diabetic Nephropathy, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with… Read more about this study
- Who is it for?
- Ages 32 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Diabetic Nephropathy
- What is being tested?
- pioglitazone+losartan and losartan
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L
- 2h plasma glucose level of 7.5-13 mmol/L
- serum creatinine values between 190 and 660umol/L
- Two occasions of a ratio of urinary albumin to urinary creatinine≥300 or 24 hours urinary protein concentration is >150mg
- Informed consent
Who cannot join
- Type1 diabetes or nondiabetic renal disease
- abnormal liver function
- heart dysfunction
About this study
Official title: Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy
Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.
- Conditions
- Type 2 Diabetes, Diabetic Nephropathy
- Being tested
- pioglitazone+losartan, losartan
- Keywords
- pioglitazone, losartan, proteinuria, end stage renal disease (ESRD)
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Proteinuria, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazone+losartanDrug
Pioglitazone (30 mg/daily) losartan (100 mg daily)
losartanDrug
losartan (100 mg daily)
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Min Jin, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hui M Jin, MD, Principal investigator, Shanghai No.3 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364988
- Sponsor's protocol ID
- PLAN
- Status last verified
- Oct 2014
- First submitted
- 14 Aug 2006
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00364988
- Acronym / sponsor ID
- PLAN
- Conditions
- Type 2 Diabetes, Diabetic Nephropathy
- Keywords
- pioglitazone, losartan, proteinuria, end stage renal disease (ESRD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 16 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 32 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L
- 2h plasma glucose level of 7.5-13 mmol/L
- serum creatinine values between 190 and 660umol/L
- Two occasions of a ratio of urinary albumin to urinary creatinine≥300 or 24 hours urinary protein concentration is >150mg
- Informed consent
Key exclusion criteria (3 listed)
- Type1 diabetes or nondiabetic renal disease
- abnormal liver function
- heart dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pioglitazone+losartanPioglitazone (30 mg/daily) losartan (100 mg daily) | Drug | – |
| losartanlosartan (100 mg daily) | Drug | – |
Primary outcome
Renal function
Time frame: 12 month
fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui M Jin, MD principal investigator
Shanghai No.3 People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing pioglitazone+losartan and losartan in people with Type 2 Diabetes and Diabetic Nephropathy, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.