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
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
- Diabetic Nephropathy
- Albuminuria
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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