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Pioglitazone and Losartan Provides Additional Renoprotection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364988
First Posted: August 16, 2006
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hui Min Jin, Shanghai Jiao Tong University School of Medicine
  Purpose
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 Intervention
Type 2 Diabetes Diabetic Nephropathy Drug: pioglitazone+losartan Drug: losartan

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hui Min Jin, Shanghai Jiao Tong University School of Medicine:

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


Enrollment: 60
Study Start Date: January 2005
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pioglitazone+losartan
    Pioglitazone (30 mg/daily) losartan (100 mg daily)
    Drug: losartan
    losartan (100 mg daily)
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: August 14, 2006
First Posted: August 16, 2006
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