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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):

August 14, 2006
August 16, 2006
October 27, 2014
January 2005
December 2005   (Final data collection date for primary outcome measure)
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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Complete list of historical versions of study NCT00364988 on ClinicalTrials.gov Archive Site
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Pioglitazone and Losartan Provides Additional Renoprotection
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Diabetic Nephropathy
  • Drug: pioglitazone+losartan
    Pioglitazone (30 mg/daily) losartan (100 mg daily)
  • Drug: losartan
    losartan (100 mg daily)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2006
December 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
32 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00364988
PLAN
Yes
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Hui Min Jin, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
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Principal Investigator: Hui M Jin, MD Shanghai No.3 People's Hospital
Shanghai Jiao Tong University School of Medicine
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP