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Pioglitazone and Losartan Provides Additional Renoprotection

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ClinicalTrials.gov Identifier: NCT00364988
Recruitment Status : Completed
First Posted : August 16, 2006
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Hui Min Jin, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Diabetic Nephropathy Drug: pioglitazone+losartan Drug: losartan Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy
Study Start Date : January 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : January 2006



Intervention Details:
    Drug: pioglitazone+losartan
    Pioglitazone (30 mg/daily) losartan (100 mg daily)
    Drug: losartan
    losartan (100 mg daily)


Primary Outcome Measures :
  1. Renal function [ Time Frame: 12 month ]
    fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)



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Ages Eligible for Study:   32 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364988


Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Hui M Jin, MD Shanghai No.3 People's Hospital

Responsible Party: Hui Min Jin, Chief,department of Nephrology,shanghai No.3 people's hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00364988     History of Changes
Other Study ID Numbers: PLAN
First Posted: August 16, 2006    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Keywords provided by Hui Min Jin, Shanghai Jiao Tong University School of Medicine:
pioglitazone
losartan
proteinuria
end stage renal disease (ESRD)

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pioglitazone
Losartan
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action