Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients

NCT01316068 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-03-16

No results posted yet for this study

Summary

Current therapies targeting albuminuria in diabetic nephropathy leave residual urinary albumin secretion, which meanwhile leave residual cardiovascular risk. Previous studies demonstrated that sulodexide could reduce albuminuria in type 2 diabetic patients. But no data concerning Chinese population is available. The investigators aim to provide evidence of effects of sulodexide on diabetic nephropathy in Chinese diabetic patients. Further the investigators also test the hypothesis that sequential administration of intravenous and oral replacement of the drug would gain an earlier and greater reduction of albuminuria, compared with oral use only.

Conditions

Interventions

DRUG

intravenous use of sulodexide followed by oral use

Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.

DRUG

use of sulodexide orally only

Patients receive 1000 LSU per day orally for 52 weeks

Sponsors & Collaborators

  • ALFA WASSERMANN(BJ) Market Research and Management Co., Ltd

    collaborator UNKNOWN
  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yanbing Li, PhD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01316068 on ClinicalTrials.gov