Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients (Soften)

Sun Yat-sen University

Status and phase

Unknown

Phase 4

Conditions

Diabetic Nephropathy

Albuminuria

Treatments

Drug: intravenous use of sulodexide followed by oral use

Drug: use of sulodexide orally only

Study type

Interventional

Funder types

Other

Identifiers

NCT01316068

sulodexide20110311

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of type 2 diabetes based on WHO criteria
Age 18-75 years old
Serum creatinine ≤ 1.5 mg/dL (130umol/L)
Albuminuria defined by a urine albumin/creatinine ratio(ACR) according to ADA criteria 2009 (microalbuminuria by 30-299 ug albumin/mg creatinine and macroalbuminuria by ≥300 ug albumin/mg creatinine on random spot urine collection )
Continued stable seated systolic blood pressure < 180 mmHg and diastolic blood pressure < 110 mmHg
Willing to change antihypertensive medication regimen if necessary
Willing to provide written informed consent to participate in the study
Willing to take contraception,or infertility for the duration of the study

Exclusion criteria

Type 1 diabetes mellitus
Present acute diabetic complication, or severe chronic diabetic complication(e.g. proliferative diabetic retinopathy)
Complicating uncontrolled severe infection
Hepatic insufficiency or renal insufficiency or severe disturbance of lipid metabolism
Blood pressure ≥ 180/110mmHg
Severe concomitant systemic disease(e.g. cardiac insufficiency, stroke), anticipated to be unable to finish the trial
Uncooperative,unable to follow up, or anticipated unable to finish the trial
Patients with other known specific renal diseases
Untreated urinary tract infection that would impact urinary protein values
Evidence of hepatic dysfunction including total bilirubin > 2.0 mg/dL (34 mmol/L) or elevated transaminases
History of Cardiovascular disease as follows: Unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebrovascular accident, New York Heart Association Functional Class III or IV heart failure, obstructive valvular heart disease or hypertrophic cardiomyopathy
Any risk of bleeding, or platelet count < 100×109/L or anticipated surgery within research period
Active, recurrent or metastatic cancer, or known HIV infection
Participant in any experimental drug study in the past 90 days prior to the enrollment of the study, or plan to participate in any drug study during the study period
Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study
Known allergy or intolerance to any heparin-like compounds or multiple drug allergies
Lactation, pregnancy, or an anticipated or planned pregnancy during the study period
Inability to give an informed consent or to cooperate with researchers (e.g. psychiatric disorder) or history of noncompliance to medical regimen