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Pioglitazone and Losartan Provides Additional Renoprotection

Primary Purpose

Type 2 Diabetes, Diabetic Nephropathy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

pioglitazone+losartan

losartan

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring pioglitazone, losartan, proteinuria, end stage renal disease (ESRD)

Eligibility Criteria

32 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Type1 diabetes or nondiabetic renal disease abnormal liver function heart dysfunction

Sites / Locations

Outcomes

Primary Outcome Measures

Renal function

fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)

Secondary Outcome Measures

Full Information

NCT ID

NCT00364988

First Posted

August 14, 2006

Last Updated

October 23, 2014

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00364988

Brief Title

Pioglitazone and Losartan Provides Additional Renoprotection

Official Title

Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Diabetic Nephropathy

Keywords

pioglitazone, losartan, proteinuria, end stage renal disease (ESRD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

pioglitazone+losartan

Intervention Description

Pioglitazone (30 mg/daily) losartan (100 mg daily)

Intervention Type

Drug

Intervention Name(s)

losartan

Intervention Description

losartan (100 mg daily)

Primary Outcome Measure Information:

Title

Renal function

Description

fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

32 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui M Jin, MD

Organizational Affiliation

Shanghai No.3 People's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Pioglitazone and Losartan Provides Additional Renoprotection

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