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Pioglitazone and Losartan Provides Additional Renoprotection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hui Min Jin, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00364988
First received: August 14, 2006
Last updated: October 23, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Renal function [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   32 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 14, 2006
Last Updated: October 23, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Losartan
Pioglitazone
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014