Pioglitazone and Losartan Provides Additional Renoprotection

This study has been completed.

First Received on August 14, 2006. No Changes Posted

Sponsor:	Shanghai Jiao Tong University School of Medicine
Information provided by:	Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT00364988

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 Drug: losartan

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Diabetic Kidney Problems

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Estimated Enrollment:	35
Study Start Date:	January 2005

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

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

ClinicalTrials.gov Identifier:	NCT00364988 History of Changes
Other Study ID Numbers:	PLAN
Study First Received:	August 14, 2006
Last Updated:	August 14, 2006
Health Authority:	China: State 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 Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Pioglitazone
Losartan

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012