Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients (Soften)

NCT01316068 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 4
Status	UNKNOWN
Enrolment	80
Start date	2011-03
Completion	2012-08

Conditions

• Diabetic Nephropathy
• Albuminuria

Interventions

• intravenous use of sulodexide followed by oral use
• use of sulodexide orally only

Primary outcomes

• Change from Baseline in urine albumin/creatinine ratio — 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

Countries

China