NCT00364988

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2006

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

August 14, 2006

Last Update Submit

October 23, 2014

Conditions

Type 2 DiabetesDiabetic Nephropathy

Keywords

pioglitazonelosartanproteinuriaend stage renal disease (ESRD)

Outcome Measures

Primary Outcomes (1)

  • Renal function

    fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)

    12 month

Interventions

pioglitazone+losartanDRUG

Pioglitazone (30 mg/daily) losartan (100 mg daily)

losartanDRUG

losartan (100 mg daily)

Eligibility Criteria

Age32 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L
  • h 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

You may not qualify if:

  • Type1 diabetes or nondiabetic renal disease
  • abnormal liver function
  • heart dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic NephropathiesProteinuriaKidney Failure, Chronic

Interventions

Losartan

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyChronic DiseaseDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Hui M Jin, MD

    Shanghai No.3 People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief,department of Nephrology,shanghai No.3 people's hospital

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 16, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2005

Study Completion

January 1, 2006

Last Updated

October 27, 2014

Record last verified: 2014-10