Clinical Trial: Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients

Brief 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.

Detailed Summary:
Sponsor: Sun Yat-sen University

Current Primary Outcome: Change from Baseline in urine albumin/creatinine ratio [ Time Frame: 52th week since the commence of therapy ]

conversion to normoalbuminuria and at least a 25% reduction in UACR opposed to baseline, or 50% reduction in UACR opposed to baseline


Original Primary Outcome: Same as current

Current Secondary Outcome: Change from Baseline in urine albumin/creatinine ratio and serum creatinine [ Time Frame: before and 2nd,12th,24th,36th and 60th week since the commence of therapy ]

Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: March 15, 2011
Date Started: March 2011
Date Completion: August 2012
Last Updated: March 15, 2011
Last Verified: August 2010